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Regeneration of Acutely Injured Nerves With Temporary Electrical Stimulation

Regeneration of Acutely Injured Nerves With Temporary Electrical Stimulation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05721261
Acronym
REGAIN
Enrollment
110
Registered
2023-02-09
Start date
2023-08-11
Completion date
2026-09-01
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nerve Injury

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.

Interventions

DEVICETemporary Peripheral Nerve Stimulation System

Single use medical device. Therapy consists of single, 1 hour dose of electrical stimulation delivered proximal to injury site.

DEVICESham Temporary Peripheral Nerve Stimulation System

Single use medical device. Sham treatment consists of single, 1 hour dose of sham stimulation.

Sponsors

Epineuron Technologies Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Peripheral nerve injury

Exclusion criteria

* Peripheral neuropathy * Patients with any active implanted device

Design outcomes

Primary

MeasureTime frame
Sensory recovery6 months
Cumulative incidence of adverse events6 months

Countries

Canada, United States

Contacts

CONTACTTracy Cameron, PhD
tcameron@epineurontech.com905-206-0466

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026