Selectivity and excitability of upper-limb muscle activation during cervical transcutaneous spinal cord stimulation in humans.
Roberto M de Freitas, Atsushi Sasaki, Dimitry G Sayenko...
https://pubmed.ncbi.nlm.nih.gov/34138648Actively Recruiting
Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID06773286
Evaluating Spinal Cord Transcutaneous Stimulation Combined with Activity-Based Training to Improve Upper Limb Function in Acute to Subacute Cervical Spinal Cord Injury During Inpatient Rehabilitation
Led by Kessler Foundation · Updated on 2025-01-14
30
Participants Needed
1
Research Sites
86 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety, feasibility, and preliminary effectiveness of combining spinal cord transcutaneous stimulation (scTS) with activity-based training (ABT) to improve upper limb function in individuals with acute to subacute cervical spinal cord injury (SCI) during inpatient rehabilitation. The study compares this combined approach to a sham stimulation with ABT and ABT alone to explore whether it leads to better recovery of hand, arm, and trunk abilities. Researchers also seek to understand the neurophysiological changes linked to these interventions by studying cortical and spinal excitability. Participants will receive one of three interventions over 10 sessions within two weeks: scTS plus ABT, sham scTS plus ABT, or ABT only. Each session lasts 30 minutes and is part of a daily three-hour therapy routine. The active scTS involves customized stimulation applied through electrodes placed on the skin over the cervical and thoracic spine, aiming for sub-threshold muscle activation without visible contractions. The sham group experiences a brief stimulation sensation without ongoing stimulation. The ABT focuses on gross and fine motor skills, including grasping and pinching tasks tailored to individual ability. Throughout the study, participants undergo assessments before, during, immediately after the intervention, and at 1-, 2-, and 3-month follow-ups. Researchers measure changes in pain, skin integrity, upper extremity motor function, handgrip strength, and overall functional ability. Safety is monitored by tracking adverse events related to scTS, ABT, and SCI symptoms. The study completion rate is also recorded to evaluate feasibility. The total participation duration spans the intervention period plus three months of follow-up evaluations.
CONDITIONS
Official Title
Combining Spinal Cord Transcutaneous Stimulation and Activity-based Training in Inpatient Rehabilitation to Facilitate Upper Limb Function of Individuals with Acute to Subacute Cervical Spinal Cord Injury
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- At least 18 years old
- Spinal cord injury occurred less than or equal to 8 weeks ago
- Traumatic cervical spinal cord injury with lesions classified as AIS A or B at C5-C7
- Some motor dysfunction in the hands with bilateral upper extremity motor score less than 25
- Medically stable for activity-based recovery training
- Able to tolerate spinal cord transcutaneous stimulation as determined by study staff
- Able to understand and willing to sign informed consent
You will not qualify if you...
- History of seizures, head trauma, or cognitive deficits
- Surgically implanted devices such as pacemaker or metal plates in the skull
- Presence of pressure sores or skin problems
- Severe spasticity
- Medically unstable condition
- History of illicit drug abuse
- History of medical disorders affecting heart, lungs, bladder, kidneys, or other parts unrelated to spinal cord injury
- Unable or unwilling to stop anti-spasticity medications like baclofen, Xeomin, or Lioresal
- Unable to meet attendance requirements
- Currently enrolled in another interventional research study
- Unable to follow instructions or stay alert during assessments and training
AI-Screening
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1
2
3
Trial Site Locations
Total: 1 location
1
Kessler Foundation
West Orange, New Jersey, United States, 07052
Actively Recruiting
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Research Team
F
Fan Zhang, PhD
G
Gail Forrest, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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