Spinal Cord Injury Clinical Trial
Official title:
Spinal Cord Stimulation for Functional Recovery in Humans With Tetraplegia
In support of the long-term goal of developing new strategies to increase limb function after SCI, the objectives of this proposal are to: 1) Examine the behavioral and physiological effects of TESS on upper-limb muscles after cervical SCI; and 2) Maximize the recovery of reaching and grasping potential by using tailored TESS in a task-specific manner with motor training. Veterans with cervical spinal injuries and healthy volunteers will be recruited for this study.
Status | Recruiting |
Enrollment | 86 |
Est. completion date | December 31, 2025 |
Est. primary completion date | January 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: Inclusion criteria for SCI: - Male and female Veterans between 18-70 years - Chronic SCI (1 year of injury) - Cervical injury at C8 or above - damage between cervical spinal segments will be confirmed using MRI [preliminary data (Benavides et al., 2020) and analysis of MRIs in ~100 participants with cervical SCI confirm that the investigators can meet our recruitment goals. Note that most SCI in humans damage several spinal cord segments - Verification of damage to cervical spinal segments will ensure that TESS electrodes will target the injured spinal cord (Benavides et al., 2020) - Intact or impaired, but not absent, innervations in dermatomes C6, C7 and C8 during light touch and pin prick stimulus using the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) sensory scores as tested before in our studies (Bunday and Perez, 2012; Bunday et al., 2018; Benavides et al., 2020; Jo and Perez, 2020) - Able to produce a visible power grip with one hand - Can score a minimum of two (2) in the cylindrical grasp the "Prehension Ability" GRASSP - This criterion was selected to ensure that hand impairment will not interfere with the ability to perform training and the proposed tests Inclusion criteria for controls: - Males and females (18-70 years) - Right-handed - Able to complete grasping Exclusion Criteria: Exclusion criteria for SCI and control subjects: - Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease - Any debilitating disease prior to the SCI that caused exercise intolerance - Premorbid, ongoing major depression or psychosis, altered cognitive status - History of head injury or concussion, skull fractures (or any skull deficit), unexplained headaches in the last 6 months, or stroke - Pacemaker - Metal plate in skull - History of seizures - Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold, such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressants - Pregnant females - Ongoing cord compression, or a syrinx in the spinal cord, or one who suffers from a spinal cord disease such as spinal stenosis, spina bifida, or herniated cervical disk |
Country | Name | City | State |
---|---|---|---|
United States | Shirley Ryan AbilityLab | Chicago | Illinois |
United States | Edward Hines Jr. VA Hospital, Hines, IL | Hines | Illinois |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in amplitude of Motor evoked potential size | Ten stimuli (0.2 Hz) will be delivered at each intensity to plot the mean peak-to-peak amplitude of the MEP from the non-rectified response against the TMS intensity in each subject (MEP recruitment curve). | Change from baseline at study completion, average of 5 weeks | |
Primary | Change in GRASSP Test | The GRASSP will be used to asses several domains of arm/hand function in humans with cervical SCI, specifically assessing three domains of hand function: 1) strength, 2) sensibility, and 3) prehension. The time to administer the test is ~45 min. The GRASSP has 5 subsets:
Dorsal sensation: (3 locations, each scored 0-4, sum=0-12) Palmar sensation: (3 locations, each scored 0-4, sum=0-12) Strength: (10 muscles of arm and hand, motor score 0-5, sum=0-50) Prehension ability: (3 grasps (cylindrical, lateral key, tip to tip), each scored 0-4, sum=0-12) Prehension performance: There are 6 prehension tasks. Pouring water from a bottle, opening jars, picking up and turning a key, transferring 9 pegs from board to board, picking up four coins and place in slots, screwing four nuts onto bolts. Each task is scored 0-5, sum=0-30. |
Through study completion(average of 5 weeks) and during 6-month follow-up | |
Primary | Changes in amplitude of cervicomedullary motor evoked potential size | Ten Transcranial magnetic stimuli (TMS) will be delivered to plot the mean peak-to-peak amplitude of the motor and cervicomedullary evoked potentials (MEPs and CMEPs, respectively) from the non-rectified response against the TMS intensity in each subject (MEP/CMEP recruitment curves). | Change from baseline at study completion, average of 5 weeks |
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