Direct Current Neuromuscular Electrical Stimulation for Treatment of Peripheral Neuropathy
NCT05442021 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 148
Last updated 2023-05-25
Summary
This study will compare two methods of electrical stimulation (alternating current and direct current) as an adjunctive therapy to treating peripheral neuropathy. Both types of electrical stimulation have been used in clinical practice for physical therapy, however direct current stimulation is much less common and there is less known about their impact on physical therapy outcomes. The aim of this project is to show the efficacy of a novel device, the Neubie direct current device, compared to traditional TENS unit, in clinical physical therapy treatment of neuropathy. Outcomes measured will include three methods of two-point discrimination, vibration sense, pain, and score on the modified Toronto Clinical Neuropathy scale.
Conditions
Interventions
- DEVICE
-
Neubie Direct Current Electrical Stimulation Device
Direct Current Electrical Stimulation Device that uses electrodes non-invasively on the skin to stimulate muscle fibers.
- DEVICE
-
TENS
Transcutaneous Electrical Nerve Stimulation device - uses alternating current delivered through electrodes on the skin.
Sponsors & Collaborators
-
NeuFit - Neurological Fitness and Education
lead INDUSTRY
Principal Investigators
-
Ramona von Leden, PhD · NeuFit - Neurological Fitness and Education
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-08-01
- Primary Completion
- 2023-05-20
- Completion
- 2023-05-20
- FDA Device
- Yes
Countries
- United States
Study Locations
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