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

Not Applicable

Recruiting

• Conditions: Spinal Cord Injury Cervical

• Registration Number: NCT06773286
• Lead Sponsor: Kessler Foundation

Brief Summary

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.

Detailed Description

The objective of this study is to investigate the use of scTS combined with ABT in inpatient rehabilitation, to facilitate UE functional recovery for individuals with acute to subacute cervical SCI. The investigators will assess the safety, feasibility, and preliminary efficacy of the combined intervention with a 10-day regimen in a randomized, sham-controlled clinical trial. The investigators hypothesize that the combination of scTS+ABT applied in individuals with acute to subacute cervical SCI will 1) be both safe and feasible when implemented as a part of the medical care in an inpatient SCI rehabilitation program, and 2) promote greater improvements in UE function compared to sham control and ABT alone. In addition, the investigators will explore the potential neurophysiological mechanism underlying the combined intervention by evaluating the pre-post changes of cortical and spinal excitability. The investigators anticipate that the functional outcome improvements will be associated with the gains of cortical and spinal excitability.

(Aim 1) To determine whether scTS+ABT intervention is safe when applied to persons with acute to subacute cervical SCI during inpatient rehabilitation. The investigators will evaluate the intervention safety based on the adverse event reports focusing three categories: (1) scTS-related (pain/discomfort and skin integrity), (2) ABT-related (musculoskeletal injuries, heart rate, and oxygen saturation levels), and (3) SCI-related (spasticity and autonomic dysreflexia). The type, frequency, and severity of adverse events reported in scTS+ABT group will be compared to those from ABT alone group. (Aim 2) To examine whether a 10-day regimen of scTS+ABT is feasible to apply to individuals with acute to subacute SCI during an inpatient rehabilitation program. The interest and willingness of participants to enroll and complete this study will provide insight into the feasibility of scTS+ABT intervention. The investigators will assess the feasibility based on quantitative data including ease of recruitment (accrual rate) and study completion rate and compare the study completion rate in scTS+ABT and ABT alone group. (Aim 3) To evaluate the efficacy of scTS+ABT intervention in promoting UE functional recovery in acute to subacute SCI, as compared to the sham control and ABT only. Given the greatest opportunity for recovery and neuroplasticity in acute-subacute SCI stage and the promising results demonstrated in the previous chronic SCI studies, the investigators expect that applying scTS+ABT at early stages would lead to greater UE function improvements compared to scTSsham+ABT and ABT only. UE motor impairment, voluntary handgrip strength, and UE functional ability will be quantitatively assessed three time at baseline, once at the end of intervention, and once at 1-, 2-, 3-month follow up. Within-group and between-group comparison will be made to evaluate the efficacy of different interventions. (Aim 4, Exploratory) To quantify and characterize the neurophysiological changes after scTS+ABT, as compared to the sham control or ABT alone. Previous chronic studies have suggested that scTS can increase the excitability of spinal network and activate the motor neurons within spinal cord distal to the lesion, leading to restoration of voluntary motor control. Here, the investigators will examine whether a 10-day regimen of scTS+ABT applied in the acute to subacute stage can also lead to neurophysiological gains. Pre-post changes in the cortical and spinal excitability will be measured and compared to the sham control and ABT only group. As an exploratory aim, the investigators will evaluated on a subset sample of each group (n=4).

Study Timeline

• Study Start: 2024-04-08
• Status Verified: 2025-01
• Study First Submitted: 2025-01-02
• Study First Submitted QC: 2025-01-08
• Last Update Submitted: 2025-01-08
• Study First Posted: 2025-01-14
• Last Update Posted: 2025-01-14
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change of pain before and after daily intervention	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Adverse event after daily intervention session	At the end of each intervention session at 30 minutes	An adverse events survey will be completed on a daily basis to evaluate adverse effects potentially related to spinal stimulation, activity-based training, and SCI.
Change of Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) Scores	From baseline to the end of intervention at 2 weeks, post-intervention at 1 month, 2 months, and 3 months	GRASSP is a standard clinical outcome measure used to evaluate the hand and UE function in people with cervical SCI. Specifically, this outcome measure evaluates UE strength, sensation, the ability to complete different grasp patterns, and the ability to utilize those grasp patterns to successfully complete functional activities. It consists of four subtests for each upper limb: dorsal and palmar sensation, strength (tested with motor grading of 10 muscles), and prehension (distinguishes scores for qualitative and quantitative grasping). The numerical scores in each subtest provide a comprehensive assessment of UE function.
Change of voluntary handgrip forces	From baseline to the end of intervention at 2 weeks, post-intervention at 1 month, 2 months, and 3 months	Maximum voluntary handgrip forces will be measured from both hands by using a hand-held dynamometer (Echo, JTECH Medical, Midvale, Utah) with stimulation turned off. To avoid compensation movement (tenodesis), testing will be performed in a standardized way with participants seated upright, shoulder adducted and neutrally rotated, elbow flexed 90 degrees, and forearm in the neutral position. A total of three trials will be assessed on each side, with a rest break between trials. The average of three maximal force measurements per trial will be reported.
Change of the Capabilities of Upper Extremity Test (CUE-T) Scores	From baseline to the end of intervention at 2 weeks, post-intervention at 1 month, 2 months, and 3 months	The Capabilities of Upper Extremity Test (CUE-T) will be used to evaluate the functional abilities, including 19 tasks (17 unilateral and 2 bilateral). Tasks involve a range of UE movements performed across proximal and distal joints for assessment of gross and fine motor function. Scoring for each item is based on ability to complete, rate of movement and time taken.

Trial Locations

Locations (1)

Kessler Foundation; 🇺🇸 West Orange, New Jersey, United States