NCT06773286 · Kessler Foundation
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
What this study 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, treatment group$1, 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 treatment group$1 function when applied to those individuals? The investigators will assess the safety, feasibility, and preliminary effectiveness 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.
View original scientific description
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.
Interventions
OTHER
Active Stimulation
Participants will receive activity-based training (ABT) while receiving concomitant, active spinal stimulation (scTS) applied at the cervical and thoracic spinal segments over the dorsal skin with optimized and customized stimulation parameters. Round self-adhesive electrodes will be placed over the skin at the midline of spinous processes as cathodes and a pair of rectangular anodes electrodes will be placed over the anterior iliac crests of the pelvis. The stimulation waveform is rectangular pulse with 1-ms duration filled with a carrier frequency of 5kHz. Target simulation will be sub-threshold for UE muscle activation and verified by the absence of visible muscle contraction. The stimulation parameters will be adjusted as needed throughout the intervention course based on the participant's performance and comfort level. The intervention will be administered over 2 consecutive weeks, for 30mins/session and 5 sessions/week, as a part of their daily 3-hour therapy.
OTHER
Sham
The sham-control group will go through ABT paired with sham stimulation to control for placebo effects associated with the perception of scTS. Stimulation will be delivered at one cervical location. No stimulation mapping procedure will be performed. During the training session, the stimulation intensity will be briefly ramped up to a level at which the participants report perceiving the stimulation, and then ramped down to 0mA at both the start and the end of session. The stimulator and electrodes will remain attached to the participant while receiving ABT training. The intervention will be administered over 2 consecutive weeks, for 30mins/session and 5 sessions/week, as a part of their daily 3-hour therapy.
OTHER
Training only
articipants in ABT group will receive ABT only. ABT will concentrate on activities of gross UE movement, grasping, pinching, gross and fine motor skill. The hand grasp task will focus on grasping objects with different shapes and weights (i.e. weighted container and tennis ball) and placing/removing them from small storage container; the pinch task involves picking up, translating, and releasing small objects with varied sizes (i.e. blocks, dices, marble balls, nuts, etc.). The training therapist selects tasks based on participant's level of impairment and individual goals. The dosage of ABT will be 30 minutes/session, with approximately 15 minutes allocated on each side.
Primary outcome measures
Change of pain before and after daily intervention
Time frame: From the beginning to the end of each intervention session at 30 minutes
Subjects will be asked to rate their pain intensity using an 11-point Numerical Rating Scale (i.e. 0-10), before and after each intervention session. The change in pain will be documented.
Change of skin integrity before and after daily intervention session
Time frame: From the beginning to the end of each intervention session at 30 minutes
Skin integrity under electrode placement site will be assessed by a clinician before and after each session, any change i.e., redness, swelling, breakdown, will be recorded.
Study completion rate
Time frame: From enrollment to the post-intervention assessment at 3 weeks
Study completion rate will be calculated at post-intervention by dividing the number of participants who will be present at these time points by the number of individuals who are enrolled and begin the intervention.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- must be at least 18 years of age.
- must have had a spinal cord injury for less than or equal to 8 weeks.
- must have a traumatic cervical SCI with lesions (AIS A or B, C5-C7).
- must have some degree of motor dysfunction in the hand (bilateral UE motor score \<25).
- must be medically stable enough to participate in activity-based recovery training.
- must be able to tolerate spinal cord transcutaneous stimulation, as determined by study staff.
- must have ability to understand and the willingness to sign an informed consent.
Exclusion criteria
- have a history of seizures, head trauma and/or cognitive deficit
- have surgically implanted foreign bodies such as a pacemaker, metal plate in the skull, and metal inside the skull
- have a pressure sore or skin issues.
- have severe spasticity.
- in medically unstable condition.
- have a history of illicit drug abuse.
- have a history of medical disorders of my heart, lungs, bladder, kidneys or other parts of my body that are unrelated to my spinal cord injury.
- unable or unwilling to wean from anti-spasticity medication (for an example: baclofen, Xeomin, and Lioresal).
- unable to meet the attendance requirements.
- currently enrolled in another interventional research study.
- unable to follow instructions and maintain alertness during assessments and training.
Where
- West Orange, New Jersey
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 14, 2025 · Source of record for eligibility and locations