PNS Motor Stimulation Study

NCT07810712 | Completed

• 1 other identifier: RG421-21
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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. The investigators 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 is gathered.

Conditions

Stroke; Paralysis Arm; Spinal Cord Injury

Keywords

Motor stimulation; Peripheral nerve stimulator; Stimulation parameters; Electric stimulation; Rehabilitation; Neuro prosthesis

Outcome Measures

Primary Outcomes (2)

• MRC grade

  Medical Research Council (MRC) Scale for Muscle Strength shall be assessed before the intervention, with the intervention ongoing and after it is completed. The MRC scale is as follows: Grade 5: Normal strength Grade 4: Movement against gravity and resistance Grade 3: Movement against gravity over (almost) the full range Grade 2: Movement of the limb but not against gravity Grade 1: Visible contraction without movement of the limb Grade 0: No visible contraction The difference between active (baseline) muscle contraction and contraction achieved with the device shall be calculated.

  2 minutes before the stimulation; during the stimulation (1 minute) and 5 minutes after the stimulation is ceased.

• EMG

  Surface, non-invasive EMG shall be performed to assess the selected muscle before the intervention, with the intervention ongoing and after it is completed. The assessed parameter is the amplitude \[μV\]. The difference between active (baseline) muscle contraction and contraction achieved with the device shall be calculated.

  2 minutes before the stimulation; during the stimulation (1 minute) and 5 minutes after the stimulation is ceased.

Study Arms (1)

Intervention Arm

EXPERIMENTAL

Participants receiving stimulation to elicit muscle contraction.

Procedure: Stimulation of the motor unit

Interventions

Stimulation of the motor unit PROCEDURE

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.

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female, aged 18 years or above with implanted Curonix (formerly: Stimwave) PNS for radial, ulnar or median nerve;
• Functioning lower motor neuron (LMN) pathway determined by baseline EMG.

You may not qualify if:

• Age \<18yr;
• Myopathy and other LMN disorders;
• Impaired LMN pathway determined by EMG.

Sponsors & Collaborators

• Walton Centre NHS Foundation Trust: lead

Study Sites (1)

The Walton Centre NHS Foundation Trust

Liverpool, L9 7LJ, United Kingdom

Location

Related Publications (6)

• Sitthinamsuwan B, Chanvanitkulchai K, Phonwijit L, Ploypetch T, Kumthornthip W, Nunta-Aree S. Utilization of intraoperative electromyography for selecting targeted fascicles and determining the degree of fascicular resection in selective tibial neurotomy for ankle spasticity. Acta Neurochir (Wien). 2013 Jun;155(6):1143-9. doi: 10.1007/s00701-013-1686-0. Epub 2013 Apr 7.

  PMID: 23563747 BACKGROUND

• Deer TR, Esposito MF, McRoberts WP, Grider JS, Sayed D, Verrills P, Lamer TJ, Hunter CW, Slavin KV, Shah JM, Hagedorn JM, Simopoulos T, Gonzalez DA, Amirdelfan K, Jain S, Yang A, Aiyer R, Antony A, Azeem N, Levy RM, Mekhail N. A Systematic Literature Review of Peripheral Nerve Stimulation Therapies for the Treatment of Pain. Pain Med. 2020 Aug 1;21(8):1590-1603. doi: 10.1093/pm/pnaa030.

  PMID: 32803220 BACKGROUND

• Nayak R, Banik RK. Current Innovations in Peripheral Nerve Stimulation. Pain Res Treat. 2018 Sep 13;2018:9091216. doi: 10.1155/2018/9091216. eCollection 2018.

  PMID: 30302288 BACKGROUND

• Peckham PH, Keith MW, Kilgore KL, Grill JH, Wuolle KS, Thrope GB, Gorman P, Hobby J, Mulcahey MJ, Carroll S, Hentz VR, Wiegner A; Implantable Neuroprosthesis Research Group. Efficacy of an implanted neuroprosthesis for restoring hand grasp in tetraplegia: a multicenter study. Arch Phys Med Rehabil. 2001 Oct;82(10):1380-8. doi: 10.1053/apmr.2001.25910.

  PMID: 11588741 BACKGROUND

• Berenpas F, Weerdesteyn V, Geurts AC, van Alfen N. Long-term use of implanted peroneal functional electrical stimulation for stroke-affected gait: the effects on muscle and motor nerve. J Neuroeng Rehabil. 2019 Jul 10;16(1):86. doi: 10.1186/s12984-019-0556-2.

  PMID: 31292003 BACKGROUND

• Peckham PH, Knutson JS. Functional electrical stimulation for neuromuscular applications. Annu Rev Biomed Eng. 2005;7:327-60. doi: 10.1146/annurev.bioeng.6.040803.140103.

  PMID: 16004574 BACKGROUND

MeSH Terms

Conditions

Stroke; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Spinal Cord Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Deepti Bhargava, MD

  Walton Centre NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking as both participants and investigators will be aware of the intervention.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single Group - a group of participants shall receive same one-off intervention.

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 9, 2026
• Study Start: February 1, 2023
• Primary Completion: August 6, 2024
• Study Completion: August 6, 2024
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)