Spinal Cord and Peripheral Nerve Stimulation for Hand Function in SCI
This study is testing if combining physical therapy with either "Spinal cord transcutaneous stimulation" or "Paired spinal cord and peripheral nerve stimulation" can help people with spinal cord injuries (SCI) in their neck regain hand and arm function. Spinal cord transcutaneous stimulation (scTS) is a non-invasive way to stimulate the spinal cord through the skin. Paired spinal cord and peripheral nerve stimulation adds stimulation to the nerves in the arm and hand. The goal is to improve your ability to use your arms and hands for everyday tasks. To join, you must be at least 18 years old, have a stable cervical SCI for at least 6 months, and have certain hand muscle strength. Success will be measured by changes in hand function, pain levels, and how you move your hand.
- Study design
- This interventional study plans to enroll 14 participants. The phase of the study is not specified.
- What's involved
- Physical therapy combined with stimulation will be provided. The primary outcomes will be measured from enrollment to the end of treatment at 4 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcomes are measured up to 4 weeks after the start of treatment. It is not specified if there is follow-up beyond this period.
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Paired Spinal Cord and Peripheral Nerve Stimulation to Recover Hand Function in SCI
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Gail Forrest, Ph.D. · PRINCIPAL_INVESTIGATOR · Kessler Foundation
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- GRASSPFrom enrollment to the end of treatment at 4 weeks
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.
- NRSFrom enrollment to the end of treatment at 4 weeks
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
- Voluntary hand opening and closing kinematicsFrom enrollment to the end of treatment at 4 weeks
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.
- Maximal voluntary grip strengthFrom enrollment to the end of treatment at 4 weeks
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.
- Transcranial magnetic stimulation motor evoked potential (MEP)From enrollment to the end of treatment at 4 weeks
To obtain MEP, transcortical magnetic stimulation (TMS) will be delivered through a figure-of-eight coil using a monophasic current waveform to the optimal scalp position along the arm and hand representation of the primary motor cortex eliciting largest MEP (MEPmax) from targeted arm and hand muscles. Electromyographic (EMG) sensors will be applied on the participant's skin to acquire muscle data.
- F-waveFrom enrollment to the end of treatment at 4 weeks
120% of the maximum stimulation intensity causing plateauing of the M-wave will be used to elicit F-wave. Evoked responses will be recorded using low-noise, pre-amplified surface EMG electrodes placed on the arm and hand muscles to record signals.