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COMPLETED
NCT07810712
NA

PNS Motor Stimulation Study

Sponsor: Walton Centre NHS Foundation Trust

View on ClinicalTrials.gov

Summary

Paralysis is one of the most disabling features of Spinal cord injury and stroke. In select cases, where the nerve is intact, stimulation can achieve meaningful muscle contraction e.g. to restore grip and release function. Previously, products to serve this purpose had been developed and successfully implanted (Freehand device). However, they had technical and cost limitations and have gone out of production. We aim to investigate if a simple implantable and commercially available system could replicate the same function. Patients implanted with a wireless peripheral nerve stimulation (PNS) system for chronic pain in the upper limb shall be identified and approached for consent. Surface electromyography (EMG, baseline and with active contraction) shall be performed to confirm intact motor nerves. Baseline MRC (Medical Research Council Scale for Muscle Strength) grade shall be assessed. PNS shall be programmed to produce muscle contraction (within FDA approved safe limits for the device) with the EMG monitoring. The muscle contraction shall be recorded on video for further evaluation. Strength of contraction shall be assessed on the MRC scale. Stimulation parameters shall be then re-adjusted to pain-relief setting. Neurological examination shall be performed and return to baseline EMG ascertained. Data shall be analysed and the Study shall end when the data for the last participant shall be gathered.

Official title: Determination of Efficacy of Sustained Motor Contraction Generated Using StimWave Peripheral Nerve Stimulator

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

4

Start Date

2023-02-01

Completion Date

2024-08-06

Last Updated

2026-09-09

Healthy Volunteers

Yes

Interventions

PROCEDURE

Stimulation of the motor unit

A participant shall have their PNS implant to produce muscle contraction. The device shall be programmed within safe, FDA-approved limits. The contraction shall be assessed visually, with EMG and on MRC scale.

Locations (1)

The Walton Centre NHS Foundation Trust

Liverpool, United Kingdom