Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05980767
Other study ID # EPNR-CIP-003
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT04699734 - Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy N/A
Completed NCT04054804 - Digital Foot Check by Using the D-Foot, a New Software
Completed NCT05161364 - Kinetic Analysis Due to Foot Dysfunction
Not yet recruiting NCT03899298 - Safety and Clinical Outcomes With Amniotic and Umbilical Cord Tissue Therapy for Numerous Medical Conditions Phase 1
Completed NCT02970006 - Investigating Mechanisms Underlying Spinal Cord Stimulation Efficacy Using Virtual Reality and Full Body Illusion N/A
Recruiting NCT05291286 - BXQ-350 Pharmacokinetic/Pharmacodynamic Study in Cancer Patients Early Phase 1
Recruiting NCT04403802 - Voxx Human Performance Technology Socks for Chemotherapy-Induced Peripheral Neuropathy N/A
Enrolling by invitation NCT05590117 - Protective Effect of Pentoxifylline Against Chemotherapy Induced Toxicities in Patients With Colorectal Cancer Early Phase 1
Recruiting NCT05624138 - The Possible Protective Role of Ketotifen Against Oxaliplatin Induced Peripheral Neuropathy Phase 3
Recruiting NCT06121232 - Exploring the Benefit of Neuromodulation in Treating Chemo-induced Peripheral Neuropathy Using Peripheral Neuropathy Markers (Meissner's Corpuscles and Epidermal Nerve Fiber Density) and Sensory Testing (Quantitative Sensory and Gait Testing): A Single Center Feasibility Study N/A
Recruiting NCT05065554 - ACALA-R In Predominantly Demyelinating IgM Mediated Neuropathy Phase 2
Completed NCT03135535 - Micro-mobile Foot Compression and Diabetic Foot Phase 2
Recruiting NCT03037684 - Depolarising Electrical Skin Stimulation in Neuropathic and Postoperative Pain
Recruiting NCT04865185 - Effect of Topical Lidocaine on Warm and Cold Sensation in Healthy Individuals N/A
Completed NCT05093023 - ABCB1 SNPs as Predictors of PIPN
Completed NCT05410548 - Comorbidity Screening and Referral by Prosthetists N/A
Completed NCT03021174 - Exercise and Nutrition Interventions During Chemotherapy N/A
Not yet recruiting NCT06422949 - Efficacy and Safety of HILOTERM® Device for the Prevention of Peripheral Neuropathy N/A
Terminated NCT03777956 - The Effect of Lacosamide in Peripheral Neuropathic Pain Phase 2
Terminated NCT04218448 - Evaluation of the Interest of Hypno-relaxation During Somatosensory Evoked Potentials N/A