Recruiting

Electrical Stimulation

Sponsor:

Epineuron Technologies Inc.

Code:

NCT05980767

Conditions

Neuropathy;Peripheral

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Temporary Peripheral Nerve Stimulation System

Study Details

Brief summary:

A novel temporary peripheral nerve stimulation system that delivers electrical stimulation therapy in a cubital tunnel release model will be evaluated for feasibility.

Conditions

Neuropathy;Peripheral

Study ID

NCT05980767

Start date

Nov 1, 2023

Status verified date

Aug, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Ulnar neuropathy at the elbow

Exclusion Criteria:

  • Peripheral neuropathy outside of nerve of interest
  • Patients with any active implanted device

Study Design

Enrollment

26 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Experimental Intervention

Standard of care plus therapy, which consists of a single, 1 hour dose of electrical stimulation.

no intervention: Control

Standard of care only.

Interventions

Temporary Peripheral Nerve Stimulation System

Single use medical device. Therapy consists of single, 1 hour dose of electrical stimulation.

Primary outcome measure

  • Eligibility Rate [ Time Frame: 1.5 years ]
  • Recruitment Rate [ Time Frame: 1.5 years ]
  • Retention Rate [ Time Frame: 1.5 years ]

Central Contacts and Locations

Central contacts

Katelyn So, MHSc

905-206-0466clinops@epineurontech.com

Locations

Hamilton General Hospital

Recruiting

Hamilton, Ontario, Canada, L8L 2X2

Principal Investigator:

Dr. James Bain, MD, MSc, FRCSC

McMaster University Medical Centre

Recruiting

Hamilton, Ontario, Canada, L8N 3Z5

More Information

Sponsor

Epineuron Technologies Inc.

Last update posted

Aug 8, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Epineuron Technologies Inc. on 2025-08-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.