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

Kessler Foundation

Status: Enrolling

Conditions: Spinal Cord Injury Cervical

Treatments: Other: Training only; Other: Sham; Other: Active Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06773286

CSCR23ERG001 (Other Grant/Funding Number)

40652

Details and patient eligibility

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.

Full 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).

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 3 patient groups

Active Spinal Cord Transcutaneous Stimulation Combined with Activity-based Training

Active Comparator group

Description:

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.

Treatment:

Other: Active Stimulation

Sham Spinal Cord Transcutaneous Stimulation Combined with Activity-based Training

Sham Comparator group

Description:

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.

Treatment:

Other: Sham

Activity-based Training Only

Other group

Description:

Participants 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.

Treatment:

Other: Training only