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Electrical Stimulation for Cubital Tunnel Syndrome

N/A
Recruiting
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients aged >18 yr
Be older than 18 years old
Must not have
Patients were excluded if they had coexisting neurologic conditions
Patients were excluded if they had concurrent nerve injury
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new treatment for a condition called cubital tunnel syndrome. The condition can cause poor nerve function, and this new treatment may help improve nerve regeneration.

Who is the study for?
This trial is for adults over 18 with severe Cubital Tunnel Syndrome (CuTS), confirmed by specific grades and tests showing significant nerve damage in the hand muscles. It's not open to those with other nerve injuries, previous CuTS surgery, or additional neurological conditions.
What is being tested?
The study is testing if electrical stimulation can help people recover better from severe CuTS. Participants will receive this treatment as an add-on to see if it speeds up nerve regeneration compared to usual care alone.
What are the potential side effects?
Electrical stimulation may cause discomfort, skin irritation at the site of application, muscle twitching during use, and in rare cases could lead to worsening symptoms if not properly administered.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any neurological conditions.
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I do not have a current nerve injury.
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I have not had surgery for CuTS.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Motor unit number estimation
Secondary study objectives
Disability of the Arm, Shoulder and Hand (DASH) Questionnaire
Key pinch strength

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Conditioning electrical stimulationExperimental Treatment1 Intervention
Patients in the stimulation group will receive surgery as well as 1 hour of 20 Hz electrical stimulation 7 days prior to surgery
Group II: ControlActive Control1 Intervention
Control patients will receive cubital tunnel surgery and sham stimulation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Electrical stimulation
2019
Completed Phase 2
~540

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor
940 Previous Clinical Trials
434,001 Total Patients Enrolled
1 Trials studying Cubital Tunnel Syndrome
65 Patients Enrolled for Cubital Tunnel Syndrome

Media Library

Electrical stimulation Clinical Trial Eligibility Overview. Trial Name: NCT05395715 — N/A
Cubital Tunnel Syndrome Research Study Groups: Control, Conditioning electrical stimulation
Cubital Tunnel Syndrome Clinical Trial 2023: Electrical stimulation Highlights & Side Effects. Trial Name: NCT05395715 — N/A
Electrical stimulation 2023 Treatment Timeline for Medical Study. Trial Name: NCT05395715 — N/A
~10 spots leftby Mar 2026
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