On the recovery of disorders of consciousness under intrathecal baclofen administration for severe spasticity-An observational study.

BACKGROUND: Occasionally, patients show dramatic recovery from disorders of consciousness (DOC) under intrathecal baclofen (ITB), an established treatment option for severe supraspinal spasticity. Anecdotal explanations for ITB-related recovery of cognition include modulation of afferent impulses at the spinal level, thereby reducing spasticity-related proprioceptive information overload within cortico-thalamo-cortical connections. OBJECTIVE: In this retrospective patient chart analysis, we assessed whether a reduction in spasticity would be associated with an increase in Coma Recovery Scale revised (CRS-R) scores in a larger sample of patients than previously published. METHODS: From a hospital-based ITB treatment register, we extracted data from 26 patients with DOC and severe supraspinal spasticity who improved by >2 points on the Coma Recovery Scale revised (CRS-R) within 6 months after ITB treatment initiation. We assessed Modified Ashworth scale (MAS) scores and CRS-R scores on admission (PRE) and 3 and 6 months after initiation of ITB treatment (3M, 6M). We performed correlation analysis of the scores and their respective changes (PRE to 3M, 3M to 6M). We also correlated the time from acute event until ITB initiation to CRS-R scores at 3M and 6M. RESULTS: ITB led to significant improvement in spasticity based on MAS scores, which did not correlate to the improvements seen in CRS-R total and subscale scores. Daily ITB dose did neither correlate to MAS scores nor to CRS-total scores in the whole patient group, but after 3 months, ITB dose correlated to some CRS-R subscale scores in some patient subgroups. Time until ITB treatment did not correlate to CRS-R scores later on. CONCLUSIONS: Our data confirm that ITB may exert beneficial effects in selected DOC patients with respect to improved cognitive functions, which, however, do not correlate to its antispastic effect. The lack of correlation between time to ITB and CRS-R outcome, but significant CRS-R improvements following pump implantation, renders spontaneous remissions unlikely and leaves room for alternative pharmacological mechanisms.

Complications After Dual Placement of a Baclofen Pump and Ventricular Shunt in Individuals With Severe Brain Injury.

OBJECTIVE: To assess the complications of dual placement of an intrathecal baclofen (ITB) pump and a ventriculoperitoneal shunt (VPS) in people with severe brain injury. DESIGN: Case series. SETTING: Referral center, ambulatory, and hospitalized care. PARTICIPANTS: Referred sample (N=9) composed of 5 men and 4 women with severe brain injuries (5 traumatic brain injuries, 3 subarachnoid hemorrhages, 1 intracerebral hemorrhage) and a mean disease duration of 6±4.5 years (range, 0.5-11.4y). INTERVENTION: Both systems (ie, an ITB device and a VPS system) were implanted in all participants. MAIN OUTCOME MEASURES: We assessed the number and type of complications that occurred after implantation of the second system, as well as subsequent interventions. RESULTS: The ITB delivery system was implanted after the VPS system in 5 patients (ITB group), and the VPS system was the second implanted system in 4 groups (VPS group). Seven complications occurred in 7 patients after implantation of the second system, 4 in the ITB group and 3 in the VPS group. Three of the complications were drug-related, 2 were procedure-related, and 2 were device-related. The complication occurred within 4 days after implantation of the second system in 6 patients. CONCLUSIONS: Complications are frequent in patients who undergo implantation of both an ITB delivery device and a VPS system. Drug-related complications were more common. Complications occurred more often when an ITB device was implanted as the second system. The critical period is the first 4 days.

Intrathecal Baclofen in Hereditary Spastic Paraparesis.

Introduction: Treatment with intrathecal baclofen (ITB) is a therapeutic option in the management of severe spasticity in patients with hereditary spastic paraparesis (HSP). However, information on the impact of ITB on the natural course of disease, especially the effect of ITB on functional parameters over time is limited. Materials and Methods: We evaluated seven patients with HSP retrospectively who were treated with an ITB device. The following parameters were measured before (pre-implantation) and after implantation (post-implantation) of the ITB device at steady state dosage of ITB and annually until last follow-up: modified Ashworth Scale, Reflex Scale, modified Rankin Scale, and Rivermead Mobility Index. The ITB dosages were assessed after reaching steady state as well as annually until last follow-up. Results: The ITB device was implanted 13 ± 6 (range 9-16) years after diagnosis of HSP on average. Severe spasticity was controlled in all patients by a mean baclofen dosage of 188 ± 60 (range 145-230) µg per day at steady state post-implantation. The modified Ashworth Scale improved significantly from 3 (interquartile range [IQR] 3-3.25) to 1 (IQR 1-1.25; p = 0.046), as did the Reflex Scale from 5 (IQR 4.75-5) to 3 (IQR 2.75-3; p = 0.046) at steady state dosage of ITB. The modified Rankin Scale improved from 2 (IQR 2-2) to 1 (IQR 1-1.5; p = 0.083) and the Rivermead Mobility Index remained 14 (IQR 13.5-14 pre-implantation, IQR 14-14 post-implantation; p = 0.18). Post-implantation, spasticity improved for 2-3 years, followed by a stable phase of ambulatory and other mobility functions for 4-5 years. Thereafter, the maintenance or progressive loss of mobility depended on individual courses of the disease. No ITB-related severe side effects occurred. Discussion: Our data further support the role of ITB in the treatment of severe spasticity in patients with deteriorated walking performance suffering HSP. ITB therapy may initially improve spasticity and stabilize mobility functions for the first 6-8 years in patients with HSP.

Intrathecal Baclofen Trial Before Device Implantation: 12-Year Experience With Continuous Administration.

OBJECTIVE: To report our experience using continuous intrathecal baclofen (ITB) administration prior to a possible ITB device implantation. DESIGN: Retrospective open label study. Mean duration of follow-up 64 months. SETTING: Primary-care and referral center, ambulatory and hospitalized care. PARTICIPANTS: Patients (N=116) undergoing continuous ITB trials between 2006 and 2017. INTERVENTIONS: Continuous application of baclofen via a temporary intrathecal catheter connected to an external pump. MAIN OUTCOME MEASURES: Assessment of the modified Ashworth Scale and range of movement prior versus end of ITB trial. According to the Barthel Index, definition of high-level patients (60-100 scoring points) and low-level patients (0-55 scoring points). Calculation of the Rivermead Mobility Index in high-level patients prior versus end of ITB trial. Evaluation of occurring adverse events. RESULTS: A total of 119 ITB trials were performed in 116 patients (78 men, mean age 41±16), 113 patients completed the trials (31 of 113 high level, 82 of 113 low level). The median modified Ashworth scale improved from 4 (interquartile range [IQR] 3-4) to 2 (IQR 1-2; P≤.001), the range of movement from 2 (IQR 1-3) to 3 (IQR 3-3; P≤.001). The Rivermead Mobility Index increased from 9 (IQR 6-12) to 10 (IQR 7-12.5; P=.004) in high-level patients. Eighty-eight out of 113 patients (78%) were appropriate candidates for ITB device surgery, 75 of 88 (85%) proceeded to an implantation. A total of 69 adverse events occurred in 57 of 119 trials (48%), 37 of 69 (54%) were drug related, 32 of 69 (46%) were procedure related, and 42 of 69 (61%) were minor. The ITB device was implanted in 69 of 75 patients (92%) at last follow-up. CONCLUSIONS: Continuous administration of ITB is an effective and useful alternative to ITB bolus application during ITB screening period. Half of the patients experienced adverse events; the majority were minor events.

Dysphagia in cerebral hypoxia.

INTRODUCTION: Dysphagia is a frequent problem in various neurological disorders. However, knowledge on swallowing function in patients with cerebral hypoxia is sparse. The objective of this study is to report the development of swallowing function in a series of adolescent and young-adult patients with cerebral hypoxia. METHODS: We recruited eight patients (1 male) who were admitted to our institution after the acute phase following cerebral hypoxia. Each patient underwent detailed neurological evaluation, magnetic resonance imaging (MRI), standardized neurophysiological assessment and repeated clinical and fiber-endoscopic evaluation of swallowing. Furthermore, all patients received daily physical and occupational therapy and intensive logopedic therapy for swallowing. RESULTS: Mean age in this case series was 19.9±3.6 years (range 16-25). All eight patients initially displayed severe swallowing dysfunction, but the reflexive components of swallowing were intact in seven patients without brainstem lesions. The only patient with additional brainstem involvement initially suffered from absence of an intact swallowing reflex and developed silent aspiration. However, follow-up examinations revealed intact swallowing reflexes in all eight patients. DISCUSSION: Dysphagia is common in patients with cerebral hypoxia, mainly resulting in a delayed oral phase consistent with impaired volitional execution of swallowing. Additional lesions in the brainstem may affect the integrity of the central pattern-generating circuitry for swallowing, resulting in additional dysfunction of the non-volitional reflexive component. In conclusion, dysphagia in patients with cerebral hypoxia is a common complication particularly in the early stages of remission, while long-term prognosis with respect to swallowing is often good. Swallowing function should be closely monitored in patients with acquired brain injury.

Intrathecal baclofen in paroxysmal sympathetic hyperactivity: Impact on oral treatment.

INTRODUCTION: Intrathecal baclofen (ITB) is a commonly used treatment in severe spasticity. The main objective of this study was to assess the impact of ITB on reduction or withdrawal of oral drugs in patients with paroxysmal sympathetic hyperactivity (PSH) after severe traumatic brain injury. METHODS: We retrospectively evaluated 20 patients with PSH due to severe traumatic brain injury who were treated with ITB in a primary care and referral center of neurology. Rates of and time until complete withdrawal or possible reduction in oral baclofen and oral propranolol after ITB treatment were calculated. Moreover, vegetative parameters (heart rate and blood pressure) as well as hypertonic attacks were assessed. RESULTS: The median time of complete oral baclofen disposal was 5 ± 3.7 (CI 95% [2.9-7.1], range 0-14) days after ITB pump implantation in 20 of 20 patients, and the median time of complete oral propranolol disposal was 24 ± 62.97 (CI 95% [-7.87-55.87], range 5-191) in 15 of 20 patients. With ITB treatment, PSH improved promptly in all patients with alleviation of heart rate and blood pressure as well as reduction in attacks with motor phenomena. ITB treatment was safe and without complications. CONCLUSIONS: ITB might facilitate cutting back or dispensing with other conventional oral drugs, such as oral baclofen and oral propranolol. Our study provides further evidence that ITB treatment should be considered in patients with otherwise medically refractory PSH in severe traumatic brain injury. Further prospective multicenter studies are needed to confirm the findings of this study.

Eleven years' experience with Intrathecal Baclofen - Complications, risk factors.

Objective: Treatment with intrathecal baclofen (ITB) is commonly used in patients with severe spasticity. However, complications may occur after implantation of the ITB-device, albeit mainly procedure- and device-related problems. The aim of the study was to assess surgical- as well as catheter- and pump-related complications and define their risk factors. Methods: We retrospectively evaluated all patients with an implanted ITB-device who were treated at the Department of Neurology, Hochzirl Hospital, Zirl, Austria, between 2006 and 2016. Results: Twenty-nine of 116 (25%) patients experienced 32 complications: 5 procedure- and 27 device-related (4 pump- and 23 catheter-associated) problems occurred. Risk factors for sustaining any complication were a spinal localization of lesion (odds ratio [OR] OR 2.71, p = .021), other catheter types than an Ascenda® catheter (OR 3.87, p = .041), a lower modified Rankin Scale (median 4 vs. 5; OR 2.86, p = .015) and a higher Barthel Index (median 53 vs. 0; OR 2.84, p = .006). The median time from the last ITB-related surgery to the first complication was 18 (IQR 1-57) months. Overall, 47% complications occurred within the first year after any surgical procedure regarding the ITB-device, thereof 25% within the first month. Conclusions: Procedure- and device-related complications are frequent after implantation of an ITB-device with catheter-associated complications as the most frequently encountered problems. Patients with a spinal origin of spasticity, a lower modified Rankin Scale and a higher Barthel Index have a higher risk to sustain a complication.

Thrombolysis and clinical outcome in patients with stroke after implementation of the Tyrol Stroke Pathway: a retrospective observational study.

BACKGROUND: Intravenous thrombolysis for ischaemic stroke remains underused worldwide. We aimed to assess whether our statewide comprehensive stroke management programme would improve thrombolysis use and clinical outcome in patients. METHODS: In 2008-09, we designed the Tyrol Stroke Pathway, which provided information campaigns for the public and standardised the entire treatment pathway from stroke onset to outpatient rehabilitation. It was commenced in Tyrol, Austria, as a long-term routine-care programme and aimed to include all patients with stroke in the survey area. We focused on thrombolysis use and outcome in the first full 4 years of implementation (2010-13). FINDINGS: We enrolled 4947 (99%) of 4992 patients with ischaemic stroke who were admitted to hospitals in Tyrol; 675 (14%) of the enrollees were treated with alteplase. Thrombolysis administration in Tyrol increased after programme implementation, from 160 of 1238 patients (12·9%, 95% CI 11·1-14·9) in 2010 to 213 of 1266 patients (16·8%, 14·8-19·0) in 2013 (ptrend 2010-13<0·0001). Differences in use of thrombolysis in the nine counties of Tyrol in 2010 (range, 2·2-22·6%) were reduced by 2013 (12·1-22·5%). Median statewide door-to-needle time decreased from 49 min (IQR 35-60) in 2010 to 44 min (29-60) in 2013; symptomatic post-thrombolysis intracerebral haemorrhages occurred in 28 of 675 patients (4·1%, 95% CI 2·8-5·9) during 2010-13. In four Austrian states without similar stroke programmes, thrombolysis administration remained stable or declined between 2010 and 2013 (mean reduction 14·4%, 95% CI 10·9-17·9). Although the 3-month mortality was not affected by our programme (137 [13%] of 1060 patients in 2010 vs 143 [13%] of 1069 patients in 2013), 3-month functional outcome significantly improved (modified Rankin Scale score 0-1 in 375 [40%] of 944 patients in 2010 vs 493 [53%] of 939 in 2013; score 0-2 in 531 [56%] patients in 2010 and 615 [65%] in 2013; ptrend 2010-13<0·0001). INTERPRETATION: During the period of implementation of our comprehensive stroke management programme, thrombolysis administration increased and clinical outcome significantly improved, although mortality did not change. We hope that these results will guide health authorities and stroke physicians elsewhere when implementing similar programmes for patients with stroke. FUNDING: Reformpool of the Tyrolean Health Care Fund.

The impact of intrathecal baclofen on gastrointestinal function.

Intrathecal baclofen (ITB) application has become the first choice in the management of otherwise intractable generalized spasticity. The mechanism whereby ITB alleviates increased skeletal muscle tone is generally accepted; however, less is known about its effect on smooth muscles. The authors present two patients who developed a paralytic ileus during ITB infusion for supraspinal spasticity. In addition, they performed a retrospective chart analysis of another 12 patients receiving ITB with respect to their intestinal function. They calculated the cumulative sum of days without bowel movements plus the cumulative sum of interventions intended to promote intestinal peristalsis before and during ITB treatment. Intestinal function deteriorated in 10, remained unchanged in one, and improved in three patients compared to baseline, irrespective of concomitant oral baclofen medication. This is the first study addressing a previously unnoticed, but potentially deleterious side effect of ITB treatment. The findings suggest, however, that close observation of intestinal activity in conjunction with the generous use of prokinetic, laxantic or eubiotic drugs may allow for continuation of ITB treatment, even in particularly sensitive patients.