MedTrace Logo

High Frequency Impulse Therapy for Neuropathic Pain in NMOSD

NCT04614454 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2025-04-30

Study results available
· View outcomes & findings →

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).

Conditions

  • Neuromyelitis Optica

Interventions

DEVICE

High Frequency Impulse Therapy

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.

DEVICE

High Frequency Impulse Therapy - Sham

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

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Michael Levy, MD, PhD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-07
Primary Completion
2022-04-13
Completion
2025-01-15
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04614454 on ClinicalTrials.gov