Spinal Stimulation for Chronic Complete Tetraplegia

Study Overview
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Brief Summary
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The purpose of this study is investigate the acceptability and effectiveness of transcutaneous spinal cord stimulation in people with complete high level spinal cord injury.

Official Title
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Non-invasive Spinal Cord Stimulation Combined With Activity-based Therapy in Chronic Complete High Level Spinal Cord Injury

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Other: Therapy with and without spinal cord stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing and able to give informed consent for participation in the study Aged ≥18 years Injury level C3-C7, American Spinal Cord injury Association Impairment Scale (ASIA) A ≥1 year post-injury Medically stable, cognitively intact, and able to breathe independently Able to attend all sessions two or three times per week, for 2 h sessions and assessments Exclusion Criteria: Any implanted active metallic device including, but not limited to neurostimulators, cochlear implants, pacemakers, implantable defibrillators, or drug delivery pumps Possible, suspected, or confirmed pregnancy and/or lactation Recent history or fracture, contractures or pressure sore, deep vein thrombosis (DVT) or urinary tract, or other infection that may interfere with the intervention and training History of epilepsy and/or seizures Severe spasticity which has been unstable over the 3 months prior to enrolment and is not expected to change and/or taking varying doses of anti-spasticity medications which could not be tapered to a stable dose and are not expected to change Botulinum toxin injections within 6 months of participation Non-injury related neurological impairment Clinically significant severe depression in spite of treatment Cardiovascular disease Autonomic dysreflexia that is severe, ongoing, and has required medical treatment within the past month Skin conditions or allergies that may affect electrode placement Do not understand English Received a stem cell treatment or other treatment that could possibly promote or attenuate neuroplastic changes in spinal or cortical function, within ≥2 years of enrolment; beyond this period, they may be included, provided the treatment was conducted in an accredited facility with proper ethics and regulatory approval. Involved in any other study involving stimulation of the spinal cord within 6 months of enrolment Information regarding recent rehabilitation or exercise programmes that participants may currently be engaged in will be discussed with clinical staff and fully documented for each participant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All participants will receive study intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapy<br>Conventional physical therapy will be used with and without spinal cord stimulation to investigate improvement of upper limb function. | Other: Therapy with and without spinal cord stimulation<br>* Conventional therapy only will be followed with conventional therapy combined with electrical spinal cord stimulation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptance | Whether the treatment protocol is acceptable by people with complete tetraplegia. This will be assessed using semi structured interview results of which will be analysed qualitatively to determine the number of participants who would use the therapy on an ongoing basis. | 26 weeks at the end of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical effectiveness of spinal cord stimulation using GRASSP tool | Effectiveness of spinal cord stimulation in inducing changes in functional outcome. This will be assessed using the Graded and Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP tool). The unit is based on the GRASSP measurement scale. | 26 and 38 weeks, at the end of intervention and at follow up respectively | 
| Neurophysiological change | Effectiveness of spinal cord stimulation in inducing changes in Neurophysiological equivalence of volitional movement. This will be assessed using changes in amplitude in mV of transcranial magnetic stimulation. | 26 and 38 weeks, at the end of intervention and at follow up respectively | 
| Sensation | Change in sensation due to the intervention. This will be assessed using change the sensory score of the International Standards for Neurological classification of SCI (ISNCSCI) | 26 weeks at the end of intervention | 
| Spasticity | Changes in upper limb muscle tone using change in the Modified Ashworth Scale. | 26 weeks at the end of intervention | 
| Autonomic function | Changes in autonomic function will be assessed using changes in the AUTONOMIC STANDARDS ASSESSMENT FORM of the International Spinal Cord Injury Data Set. | 26 weeks at the end of intervention | 
| Change in perceived health status | The effect of the study on perceived health status of the participants will be assessed using QUALITY OF LIFE BASIC DATA SET of the International Spinal Cord Injury Data Set. | 26 weeks at the end of intervention |