Actively Recruiting
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
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
The purpose of this clinical trial is to understand the safety and practicality of using spinal cord transcutaneous (through the skin) stimulation in an inpatient setting as well as how the combination of activity-based training (ABT) and spinal cord transcutaneous stimulation (scTS) can improve participants' ability to use their hands, arms, and trunk in an inpatient rehabilitation program. The main questions it aims to answer are: * Is the combination of spinal cord transcutaneous stimulation and ABT is safe and practical when applied to individuals with acute to subacute cervical SCI during inpatient rehabilitation? * How the combined intervention can improve hand and arm function when applied to those individuals? The investigators will assess the safety, feasibility, and preliminary efficacy of the combined intervention and compare to a sham control (sham stimulation combined with ABT) and a ABT only group to see if the combined intervention can lead to greater function recovery. Participants will: * Receive one type of the three intervention (scTS+ABT, sham scTS+ABT, or ABT only) for 10 sessions with 30 mins/session over 2 weeks. * Receive assessment before, during, and immediately after the intervention, and at 1-month, 2-month, and 3-month follow-up visits.
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
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Kessler Foundation
West Orange, New Jersey, United States, 07052
Actively Recruiting
Research Team
F
Fan Zhang, PhD
CONTACT
G
Gail Forrest, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here