Short Duration Electrical Stimulation to Improve Outcomes After Cubital Tunnel Release (SELECT) Trial

Neuropathy;Peripheral Clinical Trial

— SELECT  

Official title:

Short Duration Electrical Stimulation to Improve Outcomes After Cubital Tunnel Release (SELECT) Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05980767
• Other study ID #: EPNR-CIP-003
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: December 2025

Study information

• Verified date: July 2023
• Source: Epineuron Technologies Inc.
• Contact: Marina Manoraj, BEng BioSci
• Phone: 905-206-0466
• Email: mmanoraj[@]epineurontech.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Ulnar neuropathy at the elbow

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Neuropathy;Peripheral
• Peripheral Nervous System Diseases

Intervention

Device:
• Temporary Peripheral Nerve Stimulation System
Single use medical device. Therapy consists of single, 1 hour dose of electrical stimulation.

Locations

Country	Name	City	State
Canada	Hamilton General Hospital	Hamilton	Ontario
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Epineuron Technologies Inc.	Federal Economic Development Agency for Southern Ontario (FedDev Ontario)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Electromyography (EMG) Denervation Absence/Presence	Measurement of electrical activity of a muscle	1.5 years
Other	Nerve Conduction Study (NCS)	Measurement of speed of electrical impulse through a nerve	1.5 years
Other	Semmes-Weinstein Monofilament Test	Evaluation of sensory recovery through the measurement of a pressure detection threshold	1.5 years
Other	Static Two-Point Discrimination	Evaluation of sensory recovery through the measurement of the threshold of discrimination	1.5 years
Other	Grip strength	Evaluation of functional recovery through the measurement of maximum grip strength	1.5 years
Other	Pinch strength	Evaluation of functional recovery through the measurement of pinch strength	1.5 years
Other	Patient Rated Ulnar Nerve Evaluation (PRUNE)	Evaluation of pain and quality of life through patient-reported questionnaire where lower scores indicate lower pain and better quality of life related to the injury	1.5 years
Primary	Eligibility Rate	Evaluation of study feasibility through the number of participants who pass all pre-operative screening eligibility criteria	1.5 years
Primary	Recruitment Rate	Evaluation of study feasibility through the number of participants who complete informed consent and are randomized into a study arm	1.5 years
Primary	Retention Rate	Evaluation of study feasibility through the number of participants who complete all study activities	1.5 years