Back to resultsShort Duration Electrical Stimulation to Improve Outcomes After Cubital Tunnel Release (SELECT) Trial (SELECT)
Primary Purpose
Neuropathy;Peripheral
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Temporary Peripheral Nerve Stimulation System
Sponsored by
About this trial
This is an interventional other trial for Neuropathy;Peripheral
Eligibility Criteria
Inclusion Criteria: Ulnar neuropathy at the elbow Exclusion Criteria: Peripheral neuropathy outside of nerve of interest Patients with any active implanted device
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Experimental Intervention
Control
Arm Description
Standard of care plus therapy, which consists of a single, 1 hour dose of electrical stimulation.
Standard of care only.
Outcomes
Primary Outcome Measures
Eligibility Rate
Evaluation of study feasibility through the number of participants who pass all pre-operative screening eligibility criteria
Recruitment Rate
Evaluation of study feasibility through the number of participants who complete informed consent and are randomized into a study arm
Retention Rate
Evaluation of study feasibility through the number of participants who complete all study activities
Secondary Outcome Measures
Full Information
NCT ID
NCT05980767
First Posted
July 14, 2023
Last Updated
July 31, 2023
Sponsor
Epineuron Technologies Inc.
Collaborators
Federal Economic Development Agency for Southern Ontario (FedDev Ontario)
1. Study Identification
Unique Protocol Identification Number
NCT05980767
Brief Title
Short Duration Electrical Stimulation to Improve Outcomes After Cubital Tunnel Release (SELECT) Trial
Acronym
SELECT
Official Title
Short Duration Electrical Stimulation to Improve Outcomes After Cubital Tunnel Release (SELECT) Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Epineuron Technologies Inc.
Collaborators
Federal Economic Development Agency for Southern Ontario (FedDev Ontario)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathy;Peripheral
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Intervention
Arm Type
Active Comparator
Arm Description
Standard of care plus therapy, which consists of a single, 1 hour dose of electrical stimulation.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard of care only.
Intervention Type
Device
Intervention Name(s)
Temporary Peripheral Nerve Stimulation System
Intervention Description
Single use medical device. Therapy consists of single, 1 hour dose of electrical stimulation.
Primary Outcome Measure Information:
Title
Eligibility Rate
Description
Evaluation of study feasibility through the number of participants who pass all pre-operative screening eligibility criteria
Time Frame
1.5 years
Title
Recruitment Rate
Description
Evaluation of study feasibility through the number of participants who complete informed consent and are randomized into a study arm
Time Frame
1.5 years
Title
Retention Rate
Description
Evaluation of study feasibility through the number of participants who complete all study activities
Time Frame
1.5 years
Other Pre-specified Outcome Measures:
Title
Electromyography (EMG) Denervation Absence/Presence
Description
Measurement of electrical activity of a muscle
Time Frame
1.5 years
Title
Nerve Conduction Study (NCS)
Description
Measurement of speed of electrical impulse through a nerve
Time Frame
1.5 years
Title
Semmes-Weinstein Monofilament Test
Description
Evaluation of sensory recovery through the measurement of a pressure detection threshold
Time Frame
1.5 years
Title
Static Two-Point Discrimination
Description
Evaluation of sensory recovery through the measurement of the threshold of discrimination
Time Frame
1.5 years
Title
Grip strength
Description
Evaluation of functional recovery through the measurement of maximum grip strength
Time Frame
1.5 years
Title
Pinch strength
Description
Evaluation of functional recovery through the measurement of pinch strength
Time Frame
1.5 years
Title
Patient Rated Ulnar Nerve Evaluation (PRUNE)
Description
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
Time Frame
1.5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Ulnar neuropathy at the elbow
Exclusion Criteria:
Peripheral neuropathy outside of nerve of interest
Patients with any active implanted device
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marina Manoraj, BEng BioSci
Phone
905-206-0466
Email
mmanoraj@epineurontech.com
12. IPD Sharing Statement
Learn more about this trial
Short Duration Electrical Stimulation to Improve Outcomes After Cubital Tunnel Release (SELECT) Trial
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