Feasibility Study of a Temporary Peripheral Nerve Stimulator
1 other identifier
interventional
25
1 country
3
Brief Summary
A novel temporary peripheral nerve stimulator will be evaluated for safety, usability, and preliminary efficacy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2021
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2021
CompletedFirst Posted
Study publicly available on registry
February 1, 2021
CompletedStudy Start
First participant enrolled
April 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 21, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 21, 2023
CompletedJuly 13, 2023
July 1, 2023
2.2 years
January 19, 2021
July 12, 2023
Conditions
Outcome Measures
Primary Outcomes (4)
Patient Tolerance to Therapy Questionnaire
Immediately after procedure
Static Two Point Discrimination
Measurement of spatial determination
6 months
Semmes-Weinstein Monofilament Test
Measurement of pressure sensitivity
6 months
DASH Questionnaire
Validated questionnaire for functionality in upper extremity injury
6 months
Secondary Outcomes (2)
Safety
6 months
Device Usability Questionnaire
Immediately after procedure
Study Arms (2)
Device Usability
EXPERIMENTALDevice usability and safety will be evaluated.
Preliminary Efficacy
EXPERIMENTALPreliminary treatment efficacy will be evaluated.
Interventions
Temporary Peripheral Nerve Stimulator to deliver 1-hr of electrical stimulation to injured nerves.
Eligibility Criteria
You may qualify if:
- Are between 18-65 years old
- Have a Sunderland II-V peripheral nerve injury of the upper extremity
- Are receiving surgery within 14 days of injury
You may not qualify if:
- Nerve plexus injuries (e.g. brachial plexus)
- Nerve gap requiring graft/conduit, or extreme joint flexion
- Polyneuropathies
- Cognitive impairment and non-English-speaking
- Uncontrolled diabetes
- Surgical intervention \> 14 days of injury
- Co-enrollment in another clinical trial
- Pregnant women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Hamilton General Hospital
Hamilton, Ontario, L8L2X2, Canada
McMaster University Medical Centre
Hamilton, Ontario, L8N3Z5, Canada
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N4A6, Canada
Related Publications (1)
Coroneos CJ, Levis C, Willand MP, So KJ, Bain JR. Clinical evaluation of a novel disposable neurostimulator used to accelerate regeneration of injured peripheral nerves in the hand. Bioelectron Med. 2025 Apr 25;11(1):9. doi: 10.1186/s42234-025-00171-y.
PMID: 40275339DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher Coroneos, MD
McMaster University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2021
First Posted
February 1, 2021
Study Start
April 1, 2021
Primary Completion
June 21, 2023
Study Completion
June 21, 2023
Last Updated
July 13, 2023
Record last verified: 2023-07