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Recruiting NCT05980767

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

No phase Interventional Neuropathy;Peripheral

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Temporary Peripheral Nerve Stimulation System.
Who it may be relevant to
Registry conditions: Neuropathy;Peripheral. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Interventions

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

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

  • Ulnar neuropathy at the elbow

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Canada · 2 centers
  • Hamilton General Hospital — Hamilton
  • McMaster University Medical Centre — Hamilton

Identifiers

NCT: NCT05980767 · EPNR-CIP-003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗