The effects of caregiver's burden on dynamic structure in disorder of consciousness families: An observational study.

INTRODUCTION: Disorder of consciousness is a clinical condition due to severe brain damage. The impact of consciousness disorder on the family is characterized by a combination of biopsychosocial factors. The burden and suffering perceived by caregivers can cause psychological distress characterized by anxiety, depression, and physical illness. The aim of the study was to investigate the interaction between family dynamics and caregiver burden. METHODS: We enlisted 35 caregivers of subjects in a minimally conscious state. Two skilled psychologists administered the Olson's Adaptability and Family Cohesion Assessment Scale and the Novak's Burden Inventory Caregiver Scale to assess family function and family burden, respectively. RESULTS: We found that the caregiver burden correlates with the family adaptability and cohesion, as well as with enmeshment, rigidity, and disengagement. CONCLUSION: Findings suggest that the traumatic event does not affect the family structure. Families are able to maintain a balanced functioning and control distress.

Neuropsychological assessment in Niemann-Pick disease type C: a systematic review.

BACKGROUND: The neuropsychological profile of Niemann-Pick type C (NP-C) patients is characterized by an early deterioration in executive functions and attention. There are few studies on cognitive impairment and on neuropsychological assessment of NP-C disease. The purpose of this review is to analyze the studies on a psychological assessment for NP-C patients. METHOD: This review aims to identify a neuropsychological assessment to evaluate cognitive domains and neuropsychological changes in these patients. There were a total of 73 articles. The search terms were identified as titles and abstracts. All articles were evaluated by title, abstract, and text. RESULTS: Only four of the 73 articles were included because they met the criteria of our review. Furthermore, in these studies, possible diagnostic protocols are proposed on NP-C subjects. DISCUSSION AND CONCLUSION: The cognitive impairment in NP-C has a negative impact on daily functioning and quality of life. Early diagnosis could identify cognitive deficits and promote cognitive interventions to improve the neuropsychological profile. The management of NP-C disease should be based on a multidisciplinary approach, to treating symptoms, preserving neurological functions, and guaranteeing the best possible quality of life. Early identification of neurological and psychological symptoms of the disease is necessary in order to decrease the progression of neurological disease and improve patient care and treatment outcomes. Furthermore, research should focus more on cognitive aspects, not only in the diagnostic process but also in the rehabilitation process.

Assessment and rehabilitation of cognitive deficit in a Niemann-Pick type C disease patient.

Niemann-Pick type C (NP-C) disease is a lipid storage disorder characterized by visceral (hepatosplenomegaly) and neurological symptoms: ataxia, dystonia, cognitive disorder, psychiatric disorder, and vertical supranuclear gaze palsy. Cognitive impairment is one of the core symptoms of NP-C disease, but there are few data about the cognitive rehabilitation treatment in NP-C patients. This case report aims to evaluate the effects of the cognitive rehabilitation treatment of a young woman affected by NP-C. Cognitive rehabilitation was performed with pc-based and paper and pencil exercises. We used a clinical approach that includes psychotherapy-based diagnostic and rehabilitation procedures and neuropsychological methods, using strategies to improve cognitive residual abilities. Our data showed an improvement of cognitive functions and quality of life after an intensive rehabilitation program.

Discovering Genotype Variants in an Infant with VACTERL through Clinical Exome Sequencing: A Support for Personalized Risk Assessment and Disease Prevention.

Congenital anomalies may have an increased risk of noncommunicable diseases (NCDs) We performed a clinical exome analysis in an infant affected by "Vertebral, Anorectal, Cardiac, Tracheoesophageal, Genitourinary, and Limb" (VACTERL) malformation association to identify potential biomarkers that may be helpful for preventing malignancy risk or other chronic processes. Among the variants, six variants that may be linked with VACTERL were identified in the exome analysis. The variants c.501G>C on OLR1 and c.-8C>G on PSMA6 were previously associated with myocardial infarction. The variants c.1936A>G on AKAP10 and c.575A>G on PON1 are linked to defects in cardiac conduction and artery disease, respectively. Alterations in metabolism were also suggested by the variants c.860G>A on EPHX2 and c.214C>A on GHRL. In addition, three variants associated with colon cancer were discovered. Specifically, the reported variants were c.723G>A on CCND1 and c.91T>A on AURKA proto-oncogenes as well as c.827A>C in the tumor suppressor PTPRJ. A further inspection identified 15 rare variants carried by cancer genes. Specifically, these mutations are located on five tumor suppressors (SDHA, RB1CC1, PTCH1, DMBT1, BCR) and eight proto-oncogenes (MERTK, CSF1R, MYB, ROS1, PCM1, FGFR2, MYH11, BRCC3) and have an allele frequency lower than 0.01 in the Genome Aggregation Database (GnomAD). We observed that the cardiac and metabolic phenotypic traits are linked with the genotype of the patient. In addition, the risk of developing neoplasia cannot be excluded a priori. Long-term surgical issues of patients with VATER syndrome could benefit from the clinical exome sequencing of a personalized risk assessment for the appearance of further disease in pubertal timing and adult age.

Neurophysiological assessment in a patient affected by Marfan syndrome.

BACKGROUND: Marfan syndrome (MS) is a hereditary connective tissue disorder characterized by different multiorgan patterns. The guidelines for MS diagnosis do not highlight the usefulness-or even the use-of any neurophysiological techniques for diagnosing this disease. Moreover, few neurophysiological studies assessing the central and peripheral nervous systems in MS subjects have been reported to date.Case presentation: We describe a male patient affected by MS. To assess sensory and nociceptive pathways in this patient, a neurophysiological assessment was performed using electroencephalogram, nerve conduction studies, and somatosensory and laser-evoked potentials. To the best of our knowledge, this is the first published case report to evaluate the role of evoked potential assessments for the study of sensory and nociceptive pathways in MS. CONCLUSION: Future studies should investigate the use of a complete neurophysiological approach for the clinical and therapeutic management of MS patients in a large sample.

Assessment of insight in hospitalized neurological patient: Cognitive profile and mood disorder.

PURPOSE: Many studies have evaluated the characteristics of insight, especially in psychiatric patient populations. However, this construct has been poorly examined within neurological disorders. We explored the relationship between altered insight, mood disorders and neurocognitive functioning in a sample of patients admitted to a neurological rehabilitation unit. METHOD: Each patient, at the time of hospitalization (T0), underwent an evaluation of the overall cognitive profile, of the frontal functions, and the compilation of scales aimed at investigating the 4 domains under examination of insight and anxiety-depressive symptomatology. After 3 months (T1), at the end of the rehabilitative and supportive treatment, the patients underwent the same evaluation performed at T0. RESULTS: Our results showed significant differences between T0 and T1 in the variables examined related to insight. In particular, there was a correlation between the global cognitive profile, including executive functions, and all insight domains. This confirms how the degree of cognitive deficit, especially of executive type, affects all levels of awareness of the individual. We have also found correlations between mood disorders and insight. In particular, our results show that depression versus anxiety plays a fundamental role in a person's awareness. CONCLUSIONS: The study of insight is fundamental not only for the relapses it could have on the patient, but also on those to health care professionals. In fact, having an adequate insight could lead to a greater motivation of the patient to be more complimentary to pharmacological and rehabilitative therapies, also favoring social reintegration.

Assessment of spinal cord stimulation and radiofrequency: Chronic pain and psychological impact.

Pain has a major impact on anxiety and depression levels. The aim of this study is to demonstrate how these symptoms (depression and anxiety) could positively influence the perception of pain after neurostimulation system implantation.We enrolled 100 patients and divided in 2 different groups, by using tests screening such as Beck Depression Inventory (BDI), Hamilton Anxiety Rating Scale (HAM-A), Nursing Rating Scale (NRS): the group with spinal cord stimulation (SCS) and the group with pulsed spinal cord radiofrequency (RFP).We highlighted a significant decrease of scores (BDI, HAM-A, NRS) in each group between T0 (baseline) and T1. Moreover, the intra-group analysis showed a positive significant correlation between NRS and depressive and anxiety symptoms.We assert that the use of alternative methods (SCS and RFP) to the traditional pharmaceutical-surgical treatments, provide the reduction of the algic and anxiety-depressant symptoms, restoring also the perception of psychological well-being.

Telerehabilitation in individuals with severe acquired brain injury: Rationale, study design, and methodology.

BACKGROUND: Severe acquired brain injury (SABI) rehabilitation should be as intensive and long as to allow the patients get the best independence and quality of life (QoL), but facing with the rehabilitation socioeconomic burden. Telerehabilitation (TR) could supply frail subjects requiring long-term rehabilitation. METHODS: A multicenter, prospective, parallel design, single-blind trial will be conducted at the IRCCS Neurolesi Bonino Pulejo (Messina, Italy) and IRCCS Hospital San Camillo (Venice, Italy) involving patients suffering from SABI and requiring home motor and cognitive rehabilitation. We will investigate the use of TR, based on advanced Information and Communication Technology (ICT) solutions, taking into account that the supervision of rehabilitation at home will be enriched with the counseling and vital parameters monitoring. The enrolled patients will be balanced for pathology, and randomized in 2 groups, performing TR (G1) or standard rehabilitation training (G2), respectively, according to a pc-generated random assignment. TR will be delivered by means of an advanced video-conferencing system, whereas the patient will be provided with low-cost monitoring devices, able to collect data about his/her health status and QoL. In both the groups each treatment (either cognitive or motor, or both as per patient functional status) will last about 1 hour a day, 5 days/week, for 12 weeks. Two structured telephone interviews will be administered to the patients (when possible) and/or their caregivers, and to all the healthcare professionals involved in the patient management, 1 week after the beginning and at the end of the TR. All the patients will undergo a complete neurological and cognitive examination performed by skilled physicians and psychologists, blindly. Clinical evaluations will be administered blindly, before and after the treatments. RESULTS: the data of this study should demonstrate that TR is at least non-inferior in comparison with the same amount of usual territorial rehabilitative physical treatments, taking into account patients' functional recovery, psychological well-being, caregiver burden, and healthcare costs. CONCLUSION: data coming from this study could demonstrate the usefulness of TR in facing the rehabilitation socioeconomic burden of managing patients with SABI, so to allow the patients get the best independence and quality of life (QoL).

Assessment of Duodopa® effects on quality of life of patients with advanced Parkinson's disease and their caregivers.

The gold standard of treatment in Parkinson's disease (PD) is levodopa/carbidopa whose long-term use induces motor and non-motor fluctuations and dyskinesias. Continuous infusion of intrajejunal levodopa/carbidopa intestinal gel (Duodopa®) reduces motor and non-motor symptoms and dyskinesias, and improves the quality of life of patients. The aim of this open observational prospective study was to evaluate the impact of Duodopa® on conditions of PD patients and caregivers, and their quality of life. We enrolled 12 patients with advanced PD and their caregivers. The PD patients were assessed at baseline, 3 and 6 months after Duodopa® treatment initiation using Unified Parkinson's Disease Rating Scale-Part III and IV (UPDRS-III and IV), Unified Dyskinesia Rating Scale (UdysRS), Beck Depression Inventory (BDI-II), Hamilton Anxiety Rating Scale (HAM-A) and Parkinson's Disease Quality of Life Questionnaire (PDQ-39). The caregivers were assessed, at the same time as the patients, using BDI-II, HAM-A, Caregiver Burden Inventory (CBI) and SF-36 Health Status Questionnaire. Six months after Duodopa® therapy, the scores of UPDRS-III and IV, UdysRS, BDI-II, HAM-A and PDQ-39 were significantly decreased (p < 0.01). After Duodopa® therapy, in caregiver group the scores of BDI-II, HAM-A and CBI were significantly decreased and the scores of SF-36 Health Status Questionnaire were significantly increased (p < 0.01). A reduction of anxiety after therapy correlated with mental status domains of SF-36 Health Status Questionnaire (r = 0.56). Overall, Duodopa® is effective even in the short time to improve the clinical conditions of PD patients and caregivers and their quality of life.

Neuropsychological assessment in migraine patients: a descriptive review on cognitive implications.

Migraine is considered a disabling disorder with highly prevalence in population. Recent studies report that migraine patients have a cognitive decline associated to structural brain alterations. We search on PubMed and Web of Science databases and screening references of included studies and review articles for additional citations. From 519 studies identified, only 16 met the inclusion criteria. All studies were conducted on 1479 migraineurs (190 non-migraine headache and 11,978 controls subject) and examined the association between migraine and cognitive impairment. The results are discordant. Indeed, while cognitive deficits during the attack of migraine are now recognized, only few studies confirmed the presence of cognitive impairment in migraine patients. Given the prevalence of migraine in the population (especially among women), and the early age of the population, an association between migraine and cognitive impairment could have substantial public health implications. Future studies should determine if specific migraine characteristics, for example, attack frequency, may impact the association between migraine and cognitive decline.

Observational study of quality of life of Parkinson's patients and their caregivers.

BACKGROUND: Parkinson's disease (PD) is a degenerative disorder that leads to a decrease in cognitive performance and affects patients' quality of life (QoL). The purpose of this study was to investigate the QoL of PD patients and their caregivers in relation to each patient's cognitive impairment. METHODS: A total of 60 subjects with idiopathic PD were recruited; all had a primary caregiver. Patients' cognitive abilities were evaluated by the Mini-Mental State Examination, the Activities of Daily Living Scale, and the Instrumental Activities of Daily Living Scale. The 39-item Parkinson's Disease Questionnaire and the 36-item Short Form Health Survey were used to assess the QoL of patients and caregivers, respectively. RESULTS: The Mini-Mental State Examination was a significant predictor of most of the QoL subscales, including mobility, stigma, social support, cognition, and physical discomfort. The Activities of Daily Living Scale and the Instrumental Activities of Daily Living Scale were significant predictors of mobility, activities of daily living, and cognition. Patients' clinical conditions also significantly affected all of the 36-item Short Form Health Survey subscales; predicted physical functioning, bodily pain, vitality, and social role functioning on the Activities of Daily Living Scale; and predicted physical functioning, physical role functioning, and emotional role functioning on the Mini-Mental State Examination. CONCLUSIONS: Our results confirm a relationship between PD patients QoL and the perceived burden of their caregivers. Indeed, patients' cognitive impairment strictly correlated to lower QoL scores in both patients and caregivers and is a strong predictor of caregiver stress and burden. These results emphasize the importance of implementing early interventions to prevent or ameliorate caregivers' burnout.

Neuropsychiatric symptoms in dementia may predict caregiver burden: a Sicilian exploratory study.

BACKGROUND: Behavioural and psychological symptoms of dementia are very common. They represent a main cause of burden and distress in caregivers and can lead to early institutionalization of patients. We aimed to find the most specific behavioural and psychological symptoms of dementia that can strongly affect the caregivers' burden. METHODS: Twenty-seven patients and their caregivers were enrolled in this study. All of the patients were affected by Alzheimer's, vascular, or frontotemporal dementia and were evaluated with the Neuropsychiatric Inventory and Mini-Mental State Examination. Caregivers were administered the Caregiver Burden Inventory. RESULTS: Apathy, depression, anxiety, and agitation were the most common symptoms and were found in up to 90% of the patients. We detected strong correlations between patient neuropsychiatric symptoms, (i.e. irritability, hallucinations, aberrant motor behavioural, depression, and agitation) and Caregiver Burden Inventory scores. Multiple regression analysis found hallucinations, irritability, and depression to be significant predictors of caregiver burden. Moreover, the Neuropsychiatric Inventory score was more closely related to caregiver burden than the Mini-Mental State Examination score. CONCLUSION: Our results revealed that demented patients' behavioural problems are related to the level of caregiver burden and distress. Further investigations are needed to differentiate the present findings among dementia subtypes and to better evaluate the effect of caregivers' personal characteristics on their own burden.

Evaluation of Qualitative Outcomes after Surgical Intervention on Patients Affected by Arteriovenous Malformations.

BACKGROUND: Arteriovenous malformations are abnormal tangles of blood vessels that cause irregular connections between arteries and veins. Rupture of arteriovenous malformations represents a frequent complication associated with a neurological impairment and physical disability. METHODS: We investigated the relationship among coping dimensions and overall quality of life (QoL), and health status after surgical intervention in 20 patients affected by arteriovenous malformations. Each patient was administered a battery of self-report questionnaires (Short Form 12 Health Survey Questionnaire, Brief COPE Inventory, Beck Depression Inventory, and Hamilton Rating Scale for Anxiety). RESULTS: We found that surgical treatment of arteriovenous malformations affected subjective well-being and emotional aspects. Coping ability influenced the QoL and the presence of anxiety and depressive symptoms. We found a significant correlation between depression and humor (r = -.47, P = .03) and between QoL and self-distraction (r = -.48, P = .03) and humor (r = .44, P = .05). In particular, humor was a significant predictor of mental health and physical health. CONCLUSIONS: The presence of anxiety and depression was the cause of deterioration of QoL, even if psychological resources used to deal with the disease significantly modified the subjective perception of well-being. The evaluation of the impact of cerebrovascular disease on QoL should be a basis for planning and evaluating therapeutic and psychological rehabilitative interventions.

Could autonomic system assessment be helpful in disorders of consciousness diagnosis? A neurophysiological study.

Although patients with chronic disorders of consciousness (DOC), including unresponsive wakefulness syndrome (UWS) and minimally conscious state (MCS), show a limited repertoire of awareness signs, owing to a large-scale cortico-thalamo-cortical functional disconnectivity, an activation of some cortical areas in response to relevant stimuli has been described by means of electrophysiological and functional neuroimaging approaches. In addition, cognitive processes associated with autonomic nervous system (ANS) responses elicited by nociceptive stimuli have been identified in some DOC patients. In an attempt to identify ANS functionality markers that could be useful in differentiating UWS and MCS individuals, we measured the amplitude, latency and γ-band power (γPOW) of ultra-late laser-evoked potentials (CLEPs) and skin reflex (SR), which both express some aspects of cognitive processes related to ANS functionality, besides other ANS parameters either during a 24(hh)-polygraphy or following a solid-state laser repetitive nociceptive stimulation. MCS showed physiological modification of vital signs (O2 saturation, hearth rate, hearth rate variability) throughout the night and a preservation of SR-γPOW, whereas UWS did not show significant variations. Following repetitive nociceptive stimulation, MCS patients had a significant increase in CLEP-γPOW, O2 saturation, hearth rate, and hearth rate variability, whereas UWS individuals did not show any significant change (but two patients, who reached high Coma Recovery Scale-Revised scores). Hence, our work suggests that a wide-spectrum electrophysiological evaluation of ANS functionality may support DOC differential diagnosis. Interestingly, the two above-mentioned UWS patients showed MCS-like vital sign modifications and electrophysiological pain responsiveness. It is therefore hypothesizable that our approach could be helpful in identifying residual aware autonomic system-related cognitive processes even in some UWS patients. Such issue draws the attention to either DOC clinical diagnosis or adequate pain treatment in DOC patients.

Robotic gait rehabilitation and substitution devices in neurological disorders: where are we now?

Gait abnormalities following neurological disorders are often disabling, negatively affecting patients' quality of life. Therefore, regaining of walking is considered one of the primary objectives of the rehabilitation process. To overcome problems related to conventional physical therapy, in the last years there has been an intense technological development of robotic devices, and robotic rehabilitation has proved to play a major role in improving one's ability to walk. The robotic rehabilitation systems can be classified into stationary and overground walking systems, and several studies have demonstrated their usefulness in patients after severe acquired brain injury, spinal cord injury and other neurological diseases, including Parkinson's disease, multiple sclerosis and cerebral palsy. In this review, we want to highlight which are the most widely used devices today for gait neurological rehabilitation, focusing on their functioning, effectiveness and challenges. Novel and promising rehabilitation tools, including the use of virtual reality, are also discussed.

Evaluating Sativex® in Neuropathic Pain Management: A Clinical and Neurophysiological Assessment in Multiple Sclerosis.

OBJECTIVE: The aim of our study was to better investigate the role of Sativex(®) in improving pain in multiple sclerosis (MS) patients by means of either clinical or neurophysiological assessment. SETTING: Pain is a common symptom of MS, affecting up to 70% of patients. Pain treatment is often unsatisfactory, although emerging drugs (including cannabinoids) are giving encouraging results. Clinical pain assessment in MS is very difficult, and more objective tools are necessary to better quantify this symptom and its potential response to the treatments. SUBJECTS AND METHODS: We enrolled 20 MS patients (10 with and 10 without neuropathic pain), who underwent a specific clinical (such as visual analog scale) and neurophysiological assessment (by means of laser-evoked potentials and transcranial magnetic stimulation), before and after 4 weeks of Sativex administration. RESULTS: One month of drug administration in MS patients with neuropathic pain successfully reduced pain rating and improved quality of life. Interestingly, such effects were paralleled by an increase of fronto-central γ-band oscillation and of pain-motor integration strength. CONCLUSIONS: Our data suggest that Sativex may be effective in improving MS-related neuropathic pain, maybe through its action on specific cortical pathways.

Tele-health services for the elderly: A novel southern Italy family needs-oriented model.

INTRODUCTION: The world population is aging. By 2050, the global population aged over 65 years will have doubled, leading to big societal challenges for ensuring healthy, independent, and productive lives for older people. Thus, innovative local and national initiatives for e-health services are growing in an attempt to overcome such problems. METHODS: We examined the effects of a telehealth system, i.e. tele-monitoring of vital parameters and neurological/psychological tele-counseling, within a family-centred service provided by a local day centre. We evaluated the clinical and neurobehavioral symptoms of 18 elderly patients (aged 65 years and over) and the care burden of their 20 caregivers, besides the usability of the tool. RESULTS: The one-way repeated analysis revealed a significant worsening in daily living activities (p < 0.01 and p = 0.02, respectively for Activities of Daily Living (ADL) and Independent IADL (IADL)) versus a significant improvement of the patients' psychiatric condition (p < 0.001), besides a significant gradual reduction of the caregivers burden (p < 0.001). Health status perception increased through time (from an average score of 5.67 ± 1.08 at baseline to 7.72 ± 1.32 at the end of the study). DISCUSSION: It appears that a telehealth system integrated in a local health care service may significantly improve elderly persons' behaviour, and also reduce the caregivers' burden.

Neurophysiological assessment for evaluating residual cognition in vegetative and minimally conscious state patients: a pilot study.

The aim of this study was to assess residual cognitive function and perform outcome evaluation in vegetative state (VS) and minimally conscious state (MCS) patients, using Neurowave, a system able to monitor event-related potentials (ERPs) induced by neurosensory stimulation. Eleven VS and five MCS patients underwent neurological examination and clinical evaluation performed using validated clinical and behavioral scales; they also underwent neurosensory stimulation, which consisted of administration of target images (rare stimuli), relevant to the patient's personal history and having emotional significance, alternated with nontarget images ("standard" stimuli), which had no emotional significance. All simultaneous ERP responses at baseline (T0) and at three months from T0 (T1) were recorded. At T0 we found significant differences between the VS and MCS patients for the N200 (p=0.02) and P300 (p=0.04) waves. The neurophysiological analysis at T1 showed a significant difference only for P300 (p=0.02), probably due to the improvements observed in the VS subjects for the N100 (p=0.009) and N200 (p=0.02) sensory components. Neurophysiological assessment for evaluating residual cognition in vegetative and minimally conscious state patients: a pilot study Our findings seem to show the value of ERP monitoring in VS and MCS patients as a means of investigating residual cognitive function. This approach could guide early therapeutic and rehabilitation interventions, and contribute to identifying better diagnostic and prognostic markers for use in unresponsive or low-responsive patients.

Diffusion tensor imaging and neuropsychologic assessment in aphasic stroke.

With the recent advances in neuroimaging it has become possible to characterize the cerebral reorganization that occurs in response to therapy and the conditions under which this reorganization occurs. Diffusion tensor imaging (DTI) is a neuroimaging technique that allows us to visualize white matter tracts and potential changes associated with different treatments. To date, only few data on structural neuroplasticity related to the recovery of poststroke aphasia were reported. We describe a case of aphasic stroke patient, who was studied before and after the intense rehabilitative treatment by using neuropsychologic evaluation and DTI examination, to assess the integrity of the arcuate fasciculus related to motor, language, and cognitive recovery.

Sexual dysfunction induced by intrathecal baclofen administration: is this the price to pay for severe spasticity management?

INTRODUCTION: Intrathecal administration of baclofen (ITB) is widely recognized as an effective treatment for severe spasticity of both spinal and supraspinal origin with fewer side effects. The lower drug dosages used for spinal intrathecal administration, acting directly on the receptor sites, result in greater therapeutic efficacy with less systemic toxicity than with oral preparations. AIM: This study aims to prospectively evaluate the effects of ITB on erectile function in male patients affected by severe spasticity. METHODS: Twenty adult male patients, with a 34.85 ± 10.27 mean age, affected by severe spasticity mainly due to spinal cord lesions (10 traumatic, three vascular, six degenerative, and one congenital in origin) and treated with ITB, were enrolled in the study. All participants underwent specific clinical scales to evaluate force, muscle tone, cognition and mood, and specific sexual questionnaires, including an accurate semi-structured interview. MAIN OUTCOME MEASURE: The International Index of Erectile Function (IIEF) was used to evaluate sexual function before and after pump implantation. RESULTS: A comparative analysis of the neurological scales and psychometric scores at T1 (baseline) and T2 (follow-up) showed statistically significant differences before and after pump implantation. In particular, we noted a significant decrease in the IIEF median scores (from 0.42 ± 0.07 to 0.14 ± 0.02, P value < 0.0001) and a correlation between ITB dosage and IIEF scores (ρ = -0.60; P < 0.05). CONCLUSIONS: This study supports previous findings on a possible negative effect of ITB on sexual function, with regard to erection. Patients who are considering ITB for treatment of severe spasticity should be informed about possible but reversible sexual side effects, especially at higher dosage. Future studies with larger samples should be fostered to confirm these findings for a better management of these, often young, patients.