Paired Spinal Cord and Peripheral Nerve Stimulation to Recover Hand Function in SCI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-02

Study Completion Date

2026-11-01

Brief Summary

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Individuals who suffer a spinal cord injury in the neck region have difficulty using their hands due to paralysis and/or weakness of their arms and hand muscles. This project aims to test the effects of pairing spinal cord and nerve stimulation combined with physical therapy training in recovering arms and hand function. The long-term goal is to provide better therapies that will improve the ability of individuals with spinal cord injuries to use their arms and hands to perform everyday tasks, similar to injury before.

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Detailed Description

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Cervical spinal cord injury (SCI) results in paralysis and/or weakness of arms and hands that severely affects the independence and quality of life post-injury. Therefore, regaining arm and hand function remains the top priority of this population. Considering that SCI is mostly incomplete in nature, recent evidence suggests that physical or occupational therapy training combined with spinal cord transcutaneous stimulation (scTS) is effective in restoring arm and hand function post-cervical SCI. scTS is a non-invasive painless technique that augments the intrinsic capacity of the spinal cord to facilitate motor function post-SCI. The beneficial effects of scTS can be further improved by coupling it with peripheral nerve stimulation (PNS), which supplies the arm and hand muscles.

This study aims to investigate how precisely timed paired application of spinal cord transcutaneous stimulation (scTS) and peripheral nerve stimulation (PNS) combined with physical therapy can improve the use of arms and hands in those with a SCI. Spinal cord transcutaneous stimulation (scTS) is a non-invasive electrical stimulation provided on top of the skin over specific areas of the spinal cord to excite the nervous system for the activity being trained and promote connections between the brain and spinal cord. Peripheral nerve stimulation (PNS) is a non-invasive electrical stimulation provided on top of the skin over specific areas of the arm, forearm, and hand to excite the peripheral nerves and promote connections between the spinal cord and the muscles involved in the activity-based recovery training. We hypothesize that precisely timed application of scTS and PNS will increase spinal cord excitability. Increased spinal cord excitability coupled with physical therapy will facilitate hand function recovery post-SCI.

Study aims:

1. To establish optimal time sequencing for the paired scTS and PNS delivery resulting in the spinal cord motor neuron excitability in non-injured (NI) and SCI participants.
2. To investigate the acute effects of paired scTS and PNS delivery on spinal cord motor neuron and corticospinal excitability.
3. To investigate the effectiveness of paired scTS and PNS along with scTS combined with AB-UET in recovering hand function post cervical SCI.
4. To identify the potential mechanisms of action underlying the observed changes in the hand function following training with paired scTS and PNS along with scTS combined with AB-UET.

This is a pretest-posttest experimental design. SCI participants will be enrolled for Aims 1, 2, 3 and 4. For SCI participants, On site medical evaluation, ASIA Impairment Scale (ISNCSCI-AIS), MVC grip strength and nerve intactness study will be collected or performed during the screening process. If the individual is potentially eligible for the study, as determined by the study physician and investigators, they will undergo pre-training assessments, 20 training sessions, and post-training assessments. Non-Injured (NI) participants will be enrolled for Aims 1 and 2.

Conditions

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Spinal Cord Injury Spinal Cord Disease Spinal Cord Injuries (SCI)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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scTS

This arm will receive 20 sessions of spinal cord transcutaneous stimulation (scTS) combined with physical therapy.

Group Type ACTIVE_COMPARATOR

Spinal cord transcutaneous stimulation

Intervention Type DEVICE

Physical therapy combined with spinal cord transcutaneous stimulation will increase activity in the paralyzed or weak arm and hand muscles in individuals with spinal cord injury. Transcutaneous spinal cord stimulation is a non-invasive stimulation strategy and are known to facilitate recovery of lost function post spinal cord injury.

scTS+PNS

This arm will receive 20 sessions of paired application of spinal cord transcutaneous stimulation (scTS) and peripheral nerve stimulation (PNS) followed by scTS combined with physical therapy.

Group Type EXPERIMENTAL

Paired spinal cord and peripheral nerve stimulation

Intervention Type DEVICE

Physical therapy combined with paired spinal cord-peripheral nerve stimulation will increase activity in the paralyzed or weak arm and hand muscles in individuals with spinal cord injury. Transcutaneous spinal cord and peripheral nerve stimulation are both non-invasive stimulation strategy and are known to facilitate recovery of lost function post spinal cord injury.

Interventions

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Spinal cord transcutaneous stimulation

Physical therapy combined with spinal cord transcutaneous stimulation will increase activity in the paralyzed or weak arm and hand muscles in individuals with spinal cord injury. Transcutaneous spinal cord stimulation is a non-invasive stimulation strategy and are known to facilitate recovery of lost function post spinal cord injury.

Intervention Type DEVICE

Paired spinal cord and peripheral nerve stimulation

Physical therapy combined with paired spinal cord-peripheral nerve stimulation will increase activity in the paralyzed or weak arm and hand muscles in individuals with spinal cord injury. Transcutaneous spinal cord and peripheral nerve stimulation are both non-invasive stimulation strategy and are known to facilitate recovery of lost function post spinal cord injury.

Intervention Type DEVICE

Other Intervention Names

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Spinal cord transcutaneous stimulation Peripheral nerve stimulation

Eligibility Criteria

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Inclusion Criteria

* At least 18 years of age
* Non-progressive cervical SCI
* Greater than or equal to 6-months post spinal cord injury
* Stable medical condition
* Viable median and ulnar nerve as evident from MMR and M-Wave recordings
* Wrist extensor and finger flexors score between 1-3 for both upper extremity for ISNCSCI motor assessment.

* At least 18 years of age

Exclusion Criteria

* Ventilator Dependent
* Untreated fracture or pressure ulcer
* Untreated psychiatric disorder or ongoing drug abuse
* Cardiac, respiratory, bladder, renal, or other untreated medical disorder unrelated to SCI
* Skeletal muscle Botox injections less than 6 months prior
* Previous tendon transfer of the arm or arms
* Any implanted pump (i.e., baclofen pump, pain pump, etc.) prior to randomization
* Pregnant at the time of enrollment or planning to become pregnant during the course of the study
* Unable or unwilling to wean from anti-spasticity medications
* History of seizure or epilepsy
* Metal in Head
* Cochlear implant
* Implanted brain stimulators
* Aneurysm clips
* Increased intracranial pressure (which lowers seizure threshold)
* Cardiac pacemaker
* Personal or family history of epilepsy
* Tricyclic antidepressants or neuroleptics (which lower seizure threshold)

For healthy volunteer/participants:

* Neurological injury or disease
* Pregnant at the time of enrollment or planning to become pregnant during the course of the study
* Personal or family history of seizure or epilepsy
* Tricyclic antidepressants or neuroleptics (which lower seizure threshold)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes