CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 46 enrolled
Drug / intervention
High Frequency Impulse Therapy +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04614454
NCT04614454Phase 2Completed

High Frequency Impulse Therapy for Neuropathic Pain in NMOSD

Massachusetts General Hospital·interventional·Posted Nov 4, 2020·Updated Apr 30, 2025

In Brief

A Phase 2 clinical trial evaluating High Frequency Impulse Therapy and High Frequency Impulse Therapy - Sham for Neuromyelitis Optica. Completed, enrolled 46 participants across 1 site.

Detailed Summary

The aim of this study is to determine whether self-administered, at-home use of a transcutaneous electrical nerve stimulating device is an effective, acceptable and feasible method of relief from neuropathic pain among patients with Neuromyelitis optica spectrum disorder (NMOSD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedNov 4, 2020
Enrollment StartJun 7, 2021
Primary CompletionApr 13, 2022
Study CompletionJan 15, 2025
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 5.7 years ago

Interventions

High Frequency Impulse Therapydevice

The home TENS unit device is an at-home transcutaneous electrical nerve stimulation unit in that it provides non-invasive transcutaneous electrical impulses to reduce pain. It is a small, wearable device that utilizes both high and low frequencies to create a nerve-block effect based on the same gating theory.

High Frequency Impulse Therapy - Shamdevice

This device looks like the experimental device but does not provide the electrical current.