StrokeNCT07810712
PNS Motor Stimulation Study
A study testing Stimulation of the motor unit in people with Stroke and Paralysis Arm, run by Walton Centre NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Paralysis Arm, Spinal Cord Injury
- What is being tested?
- Stimulation of the motor unit
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2023to 6 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Age <18yr;
- Myopathy and other LMN disorders;
- Impaired LMN pathway determined by EMG.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Walton Centre NHS Foundation Trust
Liverpool, L9 7LJ
About this study
Official title: Determination of Efficacy of Sustained Motor Contraction Generated Using StimWave Peripheral Nerve Stimulator
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.
Read more
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.
Read the detailed description
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. This concept of functional electrical stimulation has also been utilised with external orthoses, however the applicability has been limited both due to the precision required in applying the external device each time and the need of someone else to put this on, defeating the purpose.
The Investigators aim to investigate if a simple implantable and commercially available system could replicate the same function. Curonix (formerly StimWave) wireless PNS is one such system that is already CE marked and FDA approved for stimulation of peripheral nerves. It is currently used for stimulation of peripheral nerves for pain relief.
During programming for the same, to check for adequate placement, motor stimulation is routinely performed which elicits corresponding muscle twitch. Even though the parameters are approved for safety, it has not been used to generate a clinically meaningful sustained muscle contraction.
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.
If proven to be successful, the Curonix wireless PNS system has the potential capability for generating voice controlled coordinated contraction of 2-3 electrodes, all of which can be placed under local anaesthetic as day case. A system has also been developed in parallel to provide sensory feedback which will automatically adjust the strength of contraction so that the grip is adequate.
- Conditions
- Stroke, Paralysis Arm, Spinal Cord Injury
- Being tested
- Stimulation of the motor unit
- Keywords
- Motor stimulation, Peripheral nerve stimulator, Stimulation parameters, Electric stimulation, Rehabilitation, Neuro prosthesis
- Medical subject headings
- Stroke, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stimulation of the motor unitProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Participants receiving stimulation to elicit muscle contraction. Receives: Procedure: Stimulation of the motor unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 minutes before the stimulation; during the stimulation (1 minute) and 5 minutes after the stimulation is ceased.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start1 Feb 2023
- Primary completion6 Aug 2024
- Study completion6 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group - a group of participants shall receive same one-off intervention.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walton Centre NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deepti Bhargava, MD, Principal investigator, Walton Centre NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810712
- Sponsor's protocol ID
- RG421-21
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All the data analysed for the study shall be published in the medical literature.
Publications
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.
PubMed 23563747Deer 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.
PubMed 32803220Nayak R, Banik RK. Current Innovations in Peripheral Nerve Stimulation. Pain Res Treat. 2018 Sep 13;2018:9091216. doi: 10.1155/2018/9091216. eCollection 2018.
PubMed 30302288Peckham 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.
PubMed 11588741Berenpas 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.
PubMed 31292003Peckham 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.
PubMed 16004574
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Efficacy of Sustained Motor Contraction Generated Using StimWave Peripheral Nerve Stimulator
- ClinicalTrials.gov ID
- NCT07810712
- Acronym / sponsor ID
- RG421-21
- Conditions
- Stroke, Paralysis Arm, Spinal Cord Injury
- Keywords
- Motor stimulation, Peripheral nerve stimulator, Stimulation parameters, Electric stimulation, Rehabilitation, Neuro prosthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Walton Centre NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 6 Aug 2024 (actual)
- Study completion
- 6 Aug 2024 (actual)
- First posted
- 9 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. This concept of functional electrical stimulation has also been utilised with external orthoses, however the applicability has been limited both due to the precision required in applying the external device each time and the need of someone else to put this on, defeating the purpose.
The Investigators aim to investigate if a simple implantable and commercially available system could replicate the same function. Curonix (formerly StimWave) wireless PNS is one such system that is already CE marked and FDA approved for stimulation of peripheral nerves. It is currently used for stimulation of peripheral nerves for pain relief.
During programming for the same, to check for adequate placement, motor stimulation is routinely performed which elicits corresponding muscle twitch. Even though the parameters are approved for safety, it has not been used to generate a clinically meaningful sustained muscle contraction.
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.
If proven to be successful, the Curonix wireless PNS system has the potential capability for generating voice controlled coordinated contraction of 2-3 electrodes, all of which can be placed under local anaesthetic as day case. A system has also been developed in parallel to provide sensory feedback which will automatically adjust the strength of contraction so that the grip is adequate.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group - a group of participants shall receive same one-off intervention.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Procedure: Stimulation of the motor unitParticipants receiving stimulation to elicit muscle contraction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Age <18yr;
- Myopathy and other LMN disorders;
- Impaired LMN pathway determined by EMG.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stimulation of the motor unitA 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. | Procedure or surgery | Intervention Arm |
Primary outcome
MRC grade
Time frame: 2 minutes before the stimulation; during the stimulation (1 minute) and 5 minutes after the stimulation is ceased.
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.
EMG
Time frame: 2 minutes before the stimulation; during the stimulation (1 minute) and 5 minutes after the stimulation is ceased.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Background: PubMed 23563747Sitthinamsuwan 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.
- Background: PubMed 32803220Deer 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.
- Background: PubMed 30302288Nayak R, Banik RK. Current Innovations in Peripheral Nerve Stimulation. Pain Res Treat. 2018 Sep 13;2018:9091216. doi: 10.1155/2018/9091216. eCollection 2018.
- Background: PubMed 11588741Peckham 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.
- Background: PubMed 31292003Berenpas 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.
- Background: PubMed 16004574Peckham 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.
- Individual participant dataSharing planned: No. All the data analysed for the study shall be published in the medical literature.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deepti Bhargava, MD principal investigator
Walton Centre NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stimulation of the motor unit in people with Stroke and Paralysis Arm, run by Walton Centre NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRC grade (time frame: 2 minutes before the stimulation; during the stimulation (1 minute) and 5 minutes after the stimulation is ceased.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07810712, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.