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NCT04614454 · ClinicalTrials.gov registry record · Phase 2

High Frequency Impulse Therapy for Neuropathic Pain in NMOSD

A Phase 2 study of Neuromyelitis Optica, sponsored by Massachusetts General Hospital.

Completed
Registry status
Phase 2
Development phase
46
Enrollment target
1
Study location

NCT04614454: Completed Phase 2 study of Neuromyelitis Optica, sponsored by Massachusetts General Hospital.

NCT04614454 is a Phase 2 study of Neuromyelitis Optica that has completed, run by Massachusetts General Hospital. The registered enrollment target is 46 participants, below the 508-participant average among 7 other Neuromyelitis Optica trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04614454, a Phase 2 study of Neuromyelitis Optica, has completed, sponsored by Massachusetts General Hospital.

COMPLETED
Registry status
Phase 2
Development phase
46 participants
Enrollment target
1
Study location

Study 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).

Primary Outcome

The NRS scale is an 11 point scale (0-10) with 0 as no pain and 10 as worst pain to determine the pain level. The result posted here is difference between the NRS at baseline and the NRS at 4 weeks.

Conditions Studied

Interventions

  • DEVICE High Frequency Impulse Therapy
  • DEVICE High Frequency Impulse Therapy - Sham

Study Locations (1)

Massachusetts

  • Massachusetts General Hospital - Boston

Trial Details

FieldValue
Enrollment Target 46 participants
Start Date 2021-06-07
Est. Completion 2025-01-15
Phase Phase 2
Massachusetts General Hospital

2,032 total trials

What the finished NCT04614454 record still lists

NCT04614454 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 508-participant average among 7 other Neuromyelitis Optica trials with a reported enrollment target (91% lower).

The record links to 1 condition, with Neuromyelitis Optica appearing as the primary indexed condition, and to 2 interventions - of which High Frequency Impulse Therapy is the first listed.

NCT04614454 reports a single indexed study location in Massachusetts.

Frequently Asked Questions

What is clinical trial NCT04614454 about?

NCT04614454 is a clinical study titled "High Frequency Impulse Therapy for Neuropathic Pain in NMOSD". 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).

What is the current status of trial NCT04614454?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2021-06-07. Estimated completion is 2025-01-15.

What conditions does trial NCT04614454 study?

This clinical trial studies the following conditions: Neuromyelitis Optica.

What interventions are being tested in trial NCT04614454?

The interventions under investigation include: High Frequency Impulse Therapy (DEVICE), High Frequency Impulse Therapy - Sham (DEVICE).

Who is sponsoring clinical trial NCT04614454?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04614454 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT04614454, the US trial registry maintained by the National Library of Medicine. NCT04614454 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.