Regeneration of Acutely Injured Nerves With Temporary Electrical Stimulation
REGAIN
1 other identifier
interventional
110
2 countries
15
Brief Summary
A novel temporary peripheral nerve stimulation system that delivers a single dose of electrical stimulation therapy for 1 hour will be evaluated for safety and effectiveness.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2023
Typical duration for not_applicable
15 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
February 1, 2023
CompletedFirst Posted
Study publicly available on registry
February 9, 2023
CompletedStudy Start
First participant enrolled
August 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
March 16, 2026
March 1, 2026
3.1 years
February 1, 2023
March 12, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Sensory recovery
6 months
Cumulative incidence of adverse events
6 months
Study Arms (2)
Active treatment
EXPERIMENTALSham treatment
SHAM COMPARATORInterventions
Single use medical device. Therapy consists of single, 1 hour dose of electrical stimulation delivered proximal to injury site.
Single use medical device. Sham treatment consists of single, 1 hour dose of sham stimulation.
Eligibility Criteria
You may qualify if:
- Peripheral nerve injury
You may not qualify if:
- Peripheral neuropathy
- Patients with any active implanted device
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
University of Florida Health
Gainesville, Florida, 32608, United States
Orlando Health Jewett Orthopedic Institute
Orlando, Florida, 32806, United States
Louisiana State University Health Sciences Center
New Orleans, Louisiana, 70112, United States
The Curtis National Hand Center
Baltimore, Maryland, 21218, United States
WellSpan Health
York, Pennsylvania, 17403, United States
John Peter Smith Hospital
Fort Worth, Texas, 76104, United States
University of Alberta Hospital
Edmonton, Alberta, Canada
Saint John Regional Hospital
Saint John, New Brunswick, Canada
Hamilton General Hospital
Hamilton, Ontario, Canada
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Roth | McFarlane Hand & Upper Limb Centre
London, Ontario, Canada
Southlake Health
Newmarket, Ontario, Canada
Humber River Health
Toronto, Ontario, Canada
North York General Hospital
Toronto, Ontario, Canada
Trillium Health Partners
Toronto, Ontario, Canada
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2023
First Posted
February 9, 2023
Study Start
August 11, 2023
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
March 16, 2026
Record last verified: 2026-03