Impact of the cough stimulation system on the care burden and life quality of caregivers of tetraplegics.

OBJECTIVES: To determine caregiver burden and quality of life of primary family caregivers of participants with cervical SCI before and after use of the cough stimulation system (CSS). DESIGN: Prospective assessment at four timepoints via questionnaire responses. SETTING: Out-patient hospital, United States. PARTICIPANTS: 15 primary family caregivers of participants with cervical SCI completed questionnaires including a respiratory care burden index (n = 15) and a commonly employed caregiver burden inventory (n = 9), before and at the 6-month, 1-year and 2-year timepoints following use of the CSS. RESULTS: SCI participants had significant clinical improvements in terms of restoration of an effective cough and ability to manage airway secretions with use of the CSS. Restoration of expiratory muscle function with use of the CSS also resulted in less caregivers (CG) stress, greater control of their participants' breathing problems, and improvement in quality of life. Results of the caregiver burden inventory demonstrated marked reductions in caregiver burden in development items, physical health and social relationship. Overall caregiver burden fell from 43.4 ± 13.8 pre-implant to 32.4 ± 7.9 (P = 0.06), 31.7 ± 10.5 (P = 0.05), and 26.5 ± 9.3 (P = 0.01) at the 6-month, 1-year and 2-year timepoints. CONCLUSION: Use of the CSS by cervical SCI participants results in restoration of an effective cough with significant clinical benefits. While caregiver burden is very high in primary family caregivers, they derive marked improvement in caregiver burden and quality of life with implementation of this device.Trial registration: ClinicalTrials.gov identifier: NCT00116337.Trial registration: ClinicalTrials.gov identifier: NCT01659541.

Effects of restoration of cough via spinal cord stimulation on subject quality of life.

Objectives: To determine participant quality of life before and after use of the cough stimulation system (Cough System). Design: Prospective assessment of life quality at 4 timepoints via questionnaire responses. Setting: Out-patient hospital, United States. Participants: 28 subjects with spinal cord injury (SCI) completed life quality assessment questionnaires before and at the 28- 40- and 52-week timepoints following use of the Cough System. Results: Each subject demonstrated significant clinical improvements in terms of restoration of an effective cough and ability to manage airway secretions with use of the Cough System. Positive airway pressures and peak expiratory airflows approached values associated with a normal cough. Related to cough/secretion management, use of this system also resulted less interference with family life and daily activities, less financial difficulties, less requirement for caregiver assistance, less stress, less embarrassment and greater control of their breathing problems (p < 0.01), for each comparison). There also significant improvements in that their overall health and quality of life (p < 0.01, for each comparison). Subjects also reported greater ease in breathing, restored ability to sneeze and enhanced mobility. The incidence of acute respiratory tract infections fell from 1.3 ± 0.3 to 0.2 ± 0.1 events/subject year (p < 0.01). Ten subjects developed mild hemodynamic effects consistent with autonomic dysreflexia that abated completely with continued use of the Cough System. Some subjects experienced mild leg jerks during SCS, which were well tolerated and abated completely with reduction in stimulus amplitude, No subjects reported bowel or bladder leakage. Conclusion: Use of the Cough System by SCI subjects is a safe and efficacious method which significantly improves life quality and has the potential to reduce the mortality and morbidity associated with SCI.

Comparison of disc and wire electrodes to restore cough via lower thoracic spinal cord stimulation.

OBJECTIVE: To compare the safety and effectiveness of wire (WE) vs. disc (DE) electrodes to restore cough in subjects with spinal cord injury (SCI). DESIGN: Clinical trials assessing the effectiveness and clinical outcomes associated with two electrode systems to activate the expiratory muscles. SETTING: Inpatient hospital setting for DE or WE electrode insertion; outpatient evaluation of cough efficacy and instructions for home use. PARTICIPANTS: Twenty-nine subjects with SCI; 17 participants with DE and 12 with WE implants. INTERVENTION: Surgical implantation of WE or DE to restore cough. Daily application of spinal cord stimulation (SCS) at home. MAIN OUTCOME MEASURE(S): Airway pressure (P) and peak airflow (F) generation achieved with SCS; clinical parameters including ease in raising secretions, incidence of acute respiratory tract infections (RTI) and side effects. RESULTS: P and F achieved with DE and WE were not significantly different. For example, at total lung capacity (TLC) with participant effort, P was 128 ± 12 cmH2O and 118 ± 14 cmH2O, with DE and WE, respectively. The degree of difficulty in raising secretions improved markedly in both groups. The incidence of RTI per year fell from 1.3 ± 0.3 and 1.3 ± 0.5-0.3 ± 0.1 and 0.1 ± 0.1 for DE and WE groups, respectively (P < 0.01 for both when compared to pre-implant values and NS between DE and WE groups). The only significant side effect i.e. short-term autonomic dysreflexia was also similar between groups. CONCLUSIONS: The results of this investigation indicate that both DE and WE result in comparable degrees of expiratory muscle activation, clinical benefits and side effects. Importantly, SCS to restore cough can be achieved with use of WE which can be placed using minimally invasive techniques and associated reduction in cost, surgical time and overall risk.Trial registration: ClinicalTrials.gov identifier: NCT00116337., NCT01659541, FDA IDE: G980267.

Effects of Lower Thoracic Spinal Cord Stimulation on Bowel Management in Individuals With Spinal Cord Injury.

OBJECTIVE: To systematically determine whether use of the spinal cord stimulation (SCS) system to restore cough may improve bowel management (BM) in individuals with spinal cord injury (SCI). DESIGN: Experimental studies (clinical trial). SETTING: Inpatient hospital setting for electrode insertion; outpatient setting for measurement of respiratory pressures; home setting for application of SCS. PARTICIPANTS: Participants (N=5) with cervical SCI. INTERVENTION: A fully implantable SCS cough system was surgically placed in each subject. SCS was applied at home, 2-3 times/d, on a chronic basis, every time bowel regimen was performed and as needed for secretion management. Stimulus parameters were set at values resulting in near maximum airway pressure generation, which was used as an index of expiratory muscle strength. Participants also used SCS during their bowel routine. MAIN OUTCOME MEASURES: Airway pressure generation achieved with SCS. Weekly completion of Bowel Routine Log including BM time, mechanical measures, and medications used. RESULTS: Mean pressure during spontaneous efforts was 30±8 cmH2O. After a period of reconditioning, SCS resulted in pressure of 146±21 cmH2O. The time required for BM routines was reduced from 118±34 minutes to 18±2 minutes (P<.05) and was directly related to the magnitude of pressure development during SCS. Mechanical methods for BM were completely eliminated in 4 patients. No patients experienced fecal incontinence as result of SCS. Each participant also reported marked overall improvement associated with BM. CONCLUSIONS: Our results of this pilot study suggest that SCS to restore cough may be a useful method to improve BM and life quality for both patients with SCI and their caregivers. Our results indicate that the improvement in BM is secondary to restoration of intra-abdominal pressure development.

Restoration of cough via spinal cord stimulation improves pulmonary function in tetraplegics.

Background: Spinal cord injury (SCI) results in significant loss in pulmonary function secondary to respiratory muscle paralysis. Retention of secretions and atelectasis and, recurrent respiratory tract infections may also impact pulmonary function. Objective: To determine whether usage of lower thoracic spinal cord stimulation (SCS) to restore cough may improve spontaneous pulmonary function in individuals with chronic SCI. Design/Methods: 10 tetraplegics utilized SCS system on a regular daily basis. Spontaneous inspiratory capacity (IC), maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) were measured at baseline prior to usage of the device and repeated every 4-5 weeks over a 20-week period. Maximum airway pressure generation (P) during SCS (40 V, 50 Hz, 0.2 ms) at total lung capacity (TLC) with subject maximal expiratory effort, at the same timepoints were determined, as well. Results: Following daily use of SCS, mean IC improved from 1636 ± 229 to 1932 ± 239 ml (127 ± 8% of baseline values) after 20 weeks (P < 0.05). Mean MIP increased from 40 ± 7, to 50 ± 8 cmH2O (127 ± 6% of baseline values) after 20 weeks, respectively (P < 0.05). MEP also improved from 27 ± 3.7 to 33 ± 5 (127 ± 14% of baseline values) (NS). During SCS, P increased from baseline in all participants from mean 87 ± 8 cmH2O to 117 ± 14 cmH2O at weeks 20, during TLC with subject maximal expiratory effort, respectively (P < 0.05). Each subject stated that they experienced much greater ease in raising secretions with use of SCS. Conclusion: Our findings indicate that use of SCS not only improves expiratory muscle function to restore cough but also results in improvement inspiratory function, as well.

Advanced Assessment of the Upper Limb in Tetraplegia: A Three-Tiered Approach to Characterizing Paralysis.

Background: More than half of all individuals who sustain a spinal cord injury (SCI) experience some degree of impairment in the upper limb. Functional use of the arm and hand is of paramount importance to these individuals. Fortunately, the number of clinical trials and advanced interventions targeting upper limb function are increasing, generating optimism for improved recovery and restoration after SCI. New interventions for restoring function and improving recovery require more detailed examination of the motor capacities of the upper limb. Objectives: The purpose of this article is to introduce a three-tiered approach to evaluating motor function, with specific attention to the characteristics of weak and fully paralyzed muscles during acute rehabilitation. The three tiers include (1) evaluation of voluntary strength via manual muscle testing, (2) evaluation of lower motor neuron integrity in upper motor neuron-paralyzed muscles using surface electrical stimulation, and (3) evaluation of latent motor responses in paralyzed muscles that exhibit a strong response to electrical stimulation, using surface electromyographic recording electrodes. These characteristics contribute important information that can be utilized to mitigate potential secondary conditions such as contractures and identify effective interventions such as activity-based interventions or reconstructive procedures. Our goal is to encourage frontline clinicians - occupational and physical therapists who are experts in muscle assessment - to consider a more in-depth analysis of paralysis after SCI. Conclusion: Given the rapid advancements in SCI research and clinical interventions, it is critical that methods of evaluation and classification evolve. The success or failure of these interventions may depend on the specific characteristics identified in our three-tiered assessment. Without this assessment, the physiological starting point for each individual is unknown, adding significant variability in the outcomes of these interventions.

Comparison of Responsiveness and Minimal Clinically Important Difference of the Capabilities of Upper Extremity Test (CUE-T) and the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP).

Background: The Capabilities of Upper Extremity Test (CUE-T) and the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) were both developed to detect change in upper extremity (UE) function in persons with tetraplegia. Objective: To compare the responsiveness and minimal clinically important difference (MCID) of the CUE-T and the quantitative prehension (QtP) scale of the GRASSP. Methods: Subjects included 69 persons with tetraplegia: 60 with acute and 9 with chronic injuries. Subjects were assessed twice 3 months apart using the CUE-T, QtP-GRASSP, and upper extremity motor scores (UEMS). Subjects rated their impression of change in overall and right/left UE function from -7 to +7. The standardized response mean (SRM) was determined for acute subjects. MCID was estimated using a small subjective change (2-3 points) and change in UEMS. Results: Subjects were 41.9 ± 18.1 years old, neurological levels C1-C7; 25 were motor complete. For acute subjects, the SRMs for total/side CUE-T scores were 1.07/0.96, and for the QtP-GRASSP they were 0.88/0.78. MCIDs based on subjective change for total/side CUE-T scores were 11.7/6.1 points and for QtP-GRASSP were 6.4/3.0 points. Based on change in UEMS, MCIDs for total/side were 11.9/6.3 points for CUE-T and 6.0/3.3 points for QtP-GRASSP. Some subjects had changes in the CUE-T due to its arm items that were not seen with the QtP-GRASSP. Conclusion: Both the CUE-T and QtP-GRASSP are responsive to change in persons with acute cervical spinal cord injury with large SRMs. The CUE-T detects some changes in UE function not seen with the QtP-GRASSP.

Evolution of Neuroprosthetic Approaches to Restoration of Upper Extremity Function in Spinal Cord Injury.

Background: Spinal cord injury (SCI) occurring at the cervical levels can result in significantly impaired arm and hand function. People with cervical-level SCI desire improved use of their arms and hands, anticipating that regained function will result in improved independence and ultimately improved quality of life. Neuroprostheses provide the most promising method for significant gain in hand and arm function for persons with cervical-level SCI. Neuroprostheses utilize small electrical currents to activate peripheral motor nerves, resulting in controlled contraction of paralyzed muscles. Methods: A myoelectrically-controlled neuroprosthesis was evaluated in 15 arms in 13 individuals with cervical-level SCI. All individuals had motor level C5 or C6 tetraplegia. Results: This study demonstrates that an implanted neuroprosthesis utilizing myoelectric signal (MES)-controlled stimulation allows considerable flexibility in the control algorithms that can be utilized for a variety of arm and hand functions. Improved active range of motion, grip strength, and the ability to pick up and release objects were improved in all arms tested. Adverse events were few and were consistent with the experience with similar active implantable devices. Conclusion: For individuals with cervical SCI who are highly motivated, implanted neuroprostheses provide the opportunity to gain arm and hand function that cannot be gained through the use of orthotics or surgical intervention alone. Upper extremity neuroprostheses have been shown to provide increased function and independence for persons with cervical-level SCI.

Percutaneous peripheral nerve stimulation for treatment of shoulder pain after spinal cord injury: A case report.

CONTEXT: This describes the first person with spinal cord injury (SCI) treated with percutaneous peripheral nerve stimulation for chronic shoulder pain. FINDINGS: From baseline to one-week after treatment, the subject's worst pain in the last week, rated on a 0-10 numerical rating scale (BPI-SF3), decreased by 44%. Pain interference decreased and remained below baseline 12 weeks after the end of treatment. There was an associated improvement in the mental component of quality of life. CONCLUSION: This case demonstrates the feasibility of treating shoulder pain in patients with SCI with percutaneous PNS. To demonstrate efficacy further studies are required.

Upper Extremity Assessment in Tetraplegia: The Importance of Differentiating Between Upper and Lower Motor Neuron Paralysis.

Scientific advances are increasing the options for improved upper limb function in people with cervical level spinal cord injury (SCI). Some of these interventions rely on identifying an aspect of paralysis that is not uniformly assessed in SCI: the integrity of the lower motor neuron (LMN). SCI can damage both the upper motor neuron and LMN causing muscle paralysis. Differentiation between these causes of paralysis is not typically believed to be important during SCI rehabilitation because, regardless of the cause, the muscles are no longer under voluntary control by the patient. Emerging treatments designed to restore upper extremity function (eg, rescue microsurgical nerve transfers, motor learning-based interventions, functional electrical stimulation) all require knowledge of LMN status. The LMN is easily evaluated using surface electrical stimulation and does not add significant time to the standard clinical assessment of SCI. This noninvasive evaluation yields information that contributes to the development of a lifetime upper extremity care plan for maximizing function and quality of life. Given the relative simplicity of this assessment and the far-reaching implications for treatment and function, we propose that this assessment should be adopted as standard practice for acute cervical SCI.

Implanted neuroprosthesis for restoring arm and hand function in people with high level tetraplegia.

OBJECTIVE: To develop and apply an implanted neuroprosthesis to restore arm and hand function to individuals with high level tetraplegia. DESIGN: Case study. SETTING: Clinical research laboratory. PARTICIPANTS: Individuals with spinal cord injuries (N=2) at or above the C4 motor level. INTERVENTIONS: The individuals were each implanted with 2 stimulators (24 stimulation channels and 4 myoelectric recording channels total). Stimulating electrodes were placed in the shoulder and arm, being, to our knowledge, the first long-term application of spiral nerve cuff electrodes to activate a human limb. Myoelectric recording electrodes were placed in the head and neck areas. MAIN OUTCOME MEASURES: Successful installation and operation of the neuroprosthesis and electrode performance, range of motion, grasp strength, joint moments, and performance in activities of daily living. RESULTS: The neuroprosthesis system was successfully implanted in both individuals. Spiral nerve cuff electrodes were placed around upper extremity nerves and activated the intended muscles. In both individuals, the neuroprosthesis has functioned properly for at least 2.5 years postimplant. Hand, wrist, forearm, elbow, and shoulder movements were achieved. A mobile arm support was needed to support the mass of the arm during functional activities. One individual was able to perform several activities of daily living with some limitations as a result of spasticity. The second individual was able to partially complete 2 activities of daily living. CONCLUSIONS: Functional electrical stimulation is a feasible intervention for restoring arm and hand functions to individuals with high tetraplegia. Forces and movements were generated at the hand, wrist, elbow, and shoulder that allowed the performance of activities of daily living, with some limitations requiring the use of a mobile arm support to assist the stimulated shoulder forces.

The misapplication of the term spinal cord injury without radiographic abnormality (SCIWORA) in adults.

BACKGROUND: Spinal cord injury without radiographic abnormality (SCIWORA) is generally considered a disease of children; however, it is commonly used when referring to adults who have spinal cord injury without computed tomography evidence of trauma (SCIWOCTET). The purpose of this study was to describe characteristics of patients with both adult and pediatric cervical SCIWOCTET admitted to hospitals in our region. METHODS: A retrospective review of all patients admitted to our two ACS-verified trauma centers with cervical spinal cord injury from January 2005 to December 2009 was performed. All patients with vertebral or ligamentous injury identified on computed tomographic (CT) scan of the cervical spine were excluded. Data gathered on the remaining patients included demographics, injury mechanism, Injury Severity Score, neurologic level and severity of spinal cord injury, magnetic resonance imaging results, and mortality rates. RESULTS: During the 5-year period of this study, 11,644 adult patients and 3,458 pediatric trauma patients were admitted. Of these, 313 patients were thought to have cervical spinal cord injury based on International Classification of Diseases, Ninth Revision (ICD-9) codes, 279 (89.1%) were excluded due to injury noted on CT cervical spine, and 9 were excluded as they were found to not truly have cervical spinal cord injury after review of the medical record. The remaining 25 patients were identified as having cervical SCIWOCTET. Twenty-three patients (92%) were male. The patient ages ranged from 10 to 83 years with a median age of 56 years. The mean Injury Severity Score was 22.6. Sixty-eight percent had a mechanism of fall. Degenerative changes were found on the CT scan of the cervical spine in 96% of all patients and in all 24 adult patients. There was only one pediatric patient with SCIWORA, a 10-year-old boy who had a normal CT scan of the cervical spine but had a persistent neurologic deficit. CONCLUSION: SCIWOCTET is mainly a disease of adults, and its subset SCIWORA, a disease of children, is much less common. Adults with this disease have CT scans showing canal stenosis and significant degenerative changes in the cervical spine; thus, it is not accurate to state that they have SCIWORA. The characteristics of this patient population are important as SCIWOCTET is the concern when clearing the cervical spines of trauma patients with a CT scan of the cervical spine negative for injury. LEVEL OF EVIDENCE: Epidemiologic study, level III.

A descriptive study on vitamin D levels in individuals with spinal cord injury in an acute inpatient rehabilitation setting.

OBJECTIVE: To determine the prevalence of inadequate or severely deficient levels of vitamin D in patients with spinal cord injury (SCI) admitted to an inpatient rehabilitation service and to describe any associations between patient demographics and injury characteristics and vitamin D levels. DESIGN: Retrospective case series. SETTING: Academic inpatient SCI rehabilitation program. SUBJECTS: One hundred patients with SCI who were consecutively admitted to acute inpatient rehabilitation from January to December 2007. METHODS: Data were retrospectively abstracted from the patient's medical chart. OUTCOME MEASURE: VitD-25(OH). RESULTS: The prevalence of VitD-25(OH) inadequacy or severe deficiency was 93% in this sample of patients with SCI. The mean VitD-25(OH) level was 16.29 +/- 7.73 ng/mL, with a range from 7.00 to 36.80 ng/mL. Twenty-one percent of the sample had VitD-25(OH) levels that were considered as severely deficient (< or =10 ng/mL). African-American subjects had statistically significant lower mean VitD-25(OH) levels compared with Caucasian subjects (12.96 versus 17.79 ng/mL; P = .003). Persons with an incomplete injury had significant lower mean VitD-25(OH) levels compared with complete injuries (14.64 versus 18.15 ng/mL; P = .023). CONCLUSIONS: Inadequate or severely deficient levels of VitD-25(OH) were highly prevalent in patients with SCI admitted to an acute inpatient rehabilitation service. Evaluation of serum VitD-25(OH) levels are recommended in patients with SCI because low levels may contribute to osteoporosis.

Lower thoracic spinal cord stimulation to restore cough in patients with spinal cord injury: results of a National Institutes of Health-Sponsored clinical trial. Part II: clinical outcomes.

OBJECTIVE: To evaluate the clinical effects of spinal cord stimulation (SCS) to restore cough in subjects with cervical spinal cord injury. DESIGN: Clinical trial assessing the clinical outcomes and side effects associated with the cough system. SETTING: Outpatient hospital or residence. PARTICIPANTS: Subjects (N=9; 8 men, 1 woman) with cervical spinal cord injury. INTERVENTIONS: SCS was performed at home by either the subjects themselves or caregivers on a chronic basis and as needed for secretion management. MAIN OUTCOME MEASURES: Ease in raising secretions, requirement for trained caregiver support related to secretion management, and incidence of acute respiratory tract infections. RESULTS: The degree of difficulty in raising secretions improved markedly, and the need for alternative methods of secretion removal was virtually eliminated. Subject life quality related to respiratory care improved, with subjects reporting greater control of breathing problems and enhanced mobility. The incidence of acute respiratory tract infections fell from 2.0+/-0.5 to 0.7+/-0.4 events/subject year (P<.01), and mean level of trained caregiver support related to secretion management measured over a 2-week period decreased from 16.9+/-7.9 to 2.1+/-1.6 and 0.4+/-0.3 times/wk (P<.01) at 28 and 40 weeks after implantation of the device, respectively. Three subjects developed mild hemodynamic effects that abated completely with continued SCS. Subjects experienced mild leg jerks during SCS, which were well tolerated. There were no instances of bowel or bladder leakage. CONCLUSIONS: Restoration of cough via SCS is safe and efficacious. This method improves life quality and has the potential to reduce the morbidity and mortality associated with recurrent respiratory tract infections in this patient population.