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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKessler Foundation

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

At least 18 years of age

Non-progressive cervical SCI

Greater than or equal to 6-months post spinal cord injury

Stable medical condition

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Spinal cord transcutaneous stimulation

    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.

  • Paired spinal cord and peripheral nerve stimulation

    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.

Treatment groups

14 Participants
are divided into 2 treatment groups
Group A: scTSActive comparator 1 intervention
Group B: scTS+PNSExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

GRASSP

Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) is a 3-part assessment designed to measure participant's hand and arm function. The test specifically measures strength, sensation, and prehension. During strength testing, selected upper extremity muscles are assessed for the grade of muscle contraction or power of the muscle. During sensation testing, specific zones on the palmar and dorsal aspects of the hand are tested with Semmes Weinstein Monofilaments (SWM) with varying weights. Prehension is assessed both qualitatively and quantitatively. During the qualitative section, no specific position is required, except that the hand should be positioned appropriately for movement with assistance from the examiner, if necessary. During quantitative section, participant is asked to perform six tasks and performance is graded.

Time frame
From enrollment to the end of treatment at 4 weeks
2

NRS

Neuromuscular Recovery Scale Assessment (NRS) assesses the level of muscle activation and amount of external assistance required to perform motor tasks involving hand, arm, and trunk. The research participant will be asked to perform motor tasks as independently as possible. Research staff will score each of these tasks based on the algorithm. NRS consists of six sub-items focusing on UE function, including overhead press, shoulder flexion, grasp, door pull, open with key, and can open and manipulation. Items are scored from phase 1 to phase 4, the higher the phase, the better is the functional performance

Time frame
From enrollment to the end of treatment at 4 weeks
3

Voluntary hand opening and closing kinematics

Three-dimensional kinematic data will be collected using a motion capture system. Reflective markers will be placed on the participant's forearm, hand, and fingers to track wrist and finger movements during a maximum hand opening and closing task. Surface electrodes will be applied on the participant's skin to acquire EMG data.

Time frame
From enrollment to the end of treatment at 4 weeks
4

Maximal voluntary grip strength

For maximal voluntary grip strength, participants will be instructed to apply as much force as possible while trying to grasp or making a fist around the grip handle during a 3 second audio cue. Each MVC attempt will be followed by a rest period of 20 seconds of no activity. A total of 5 grip strength attempts will be collected.

Time frame
From enrollment to the end of treatment at 4 weeks

Secondary outcomes

1

Functional Neurophysiological assessment (FNPA)

The assessment will be performed with the participant in lying position. The participants will be asked to relax for a minimum of 5 minutes at the beginning of the assessment to acquire a baseline of the electrical noise in his/her muscles and in the room. Corresponding volitional motor tasks will then be performed to match the muscles being recorded at that time (elbow flexion to record from biceps brachii). Reflexive testing, including deep tendon reflexes, clonus, Babinski, and reaction to vibration may be performed after volitional testing.

Time frame
From enrollment to the end of treatment at 4 weeks
2

Multisegmental Motor Response (MMR)

MMR will be evoked transcutaneously by using a constant current stimulator between the C2 spinous processes and the coccyx. The cathode(s) (pre-gelled, soft surface electrodes) will be placed over the skin between C2 spinous processes and the coccyx, while large anode(s) will be placed over the clavicle, abdomen, iliac bone or at different levels or at segments just below the cathode. The stimulus intensities will be adjusted for each testing condition, i.e. supine and sitting conditions. MMRs will be recorded bilaterally from hand and arm muscles and the trunk using low-noise, pre-amplified surface electromyographic electrodes placed on the skin over the muscle to record signal

Time frame
From enrollment to the end of treatment at 4 weeks
3

Capabilities of Upper Extremity Questionnaire (CUE-Q)

The Capabilities of Upper Extremity Questionnaire (CUE-Q) is designed to assess functional capabilities of the upper extremities, specifically in individuals that have experienced a neurological injury. The CUE-Q is a 32-item questionnaire, scored by self-report through an interview with the participant. The 32 items assess six domains including unilateral (left and right) items, bilateral items, reaching items, pulling/pushing items, wrist items, and hand and finger items.

Time frame
From enrollment to the end of treatment at 4 weeks
4

Spinal Cord Injury-Quality of Life (SCI-QOL) Questionnaire

The SCI-QOL was developed to address the shortage of psychometrically sound and relevant patient reported outcome measures available for clinical card and research in SCI rehabilitation. This questionnaire is accessible through computer adaptive testing and addresses the following domains: emotional health, physical-medical health, social participation, and physical function.

Time frame
From enrollment to the end of treatment at 4 weeks

Other outcomes

Sponsors and contacts

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