High Frequency Impulse Therapy for Neuropathic Pain in NMOSD

NCT04614454 | Completed Phase 2 Results FDA Device

• 1 other identifier: 2020P003301
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in Pain Score on the Numerical Rating Score (NRS)

  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.

  4 weeks from baseline to completion of the experimental phase.

Secondary Outcomes (3)

• "Worst" Pain Score on the NRS Scale

  4 weeks from baseline to completion of the experimental phase.

• Withdrawal From Trial

  4 weeks from baseline to completion of the experimental phase.

• Quality of Life Survey

  4 weeks from baseline to completion of the experimental phase.

Study Arms (2)

Experimental arm

EXPERIMENTAL

Devices will be programmed by our study coordinator to provide a sham signal or the experimental signal. The location of the TENS electrodes will be determined by the location of the pain with the goal of placing the unit at the top of the dermatological level corresponding to the pain. The study coordinator will assist each subject to place the device appropriately. Treatment will be administered for 1 hour per day for 4 weeks.

Device: High Frequency Impulse Therapy

Sham arm

SHAM COMPARATOR

The sham unit looks identical to the experimental unit. There may be a sensation experienced by subjects with the sham device but it does not deliver an electric current as the experimental units. The study coordinator will assist each subject to place the device appropriately. Treatment will be administered for 1 hour per day for 4 weeks.

Device: High Frequency Impulse Therapy - Sham

Interventions

High Frequency Impulse Therapy DEVICE

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.

Also known as: Transcutaneous electrical nerve stimulation

Experimental arm

High Frequency Impulse Therapy - Sham DEVICE

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

Also known as: Transcutaneous electrical nerve stimulation - Sham

Sham arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women 18 years of age or older diagnosed with NMOSD per the 2015 NMOSD criteria
• Patients must be positive for the aquaporin-4 antibody in serum.
• Presence of persistent neuropathic pain (\>3 months) rated at a level of 4 or higher on the Wong-Baker Faces Pain Scale
• Patients must be stable in their disease, such that they have had no spinal cord relapses within 6 months prior to enrollment
• Patients must be on a stable medication regimen that may include anti-epileptic, antidepressant, or non-steroidal anti-inflammatory medications, with no adjustments to the regimen within 30 days of enrollment
• Pain must be localized to a spinal cord lesion
• Patient understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form

You may not qualify if:

• Patients who are cognitively or mentally incompetent
• Any of the following: pregnant women, nursing women, women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device \[IUD\], surgical sterilization, subcutaneous implants, abstinence, etc.).
• Use of an investigational agent for pain control concurrently or within the past 30 days
• History of an allergic reaction or previous intolerance to transcutaneous electronic nerve stimulation or to latex
• Patients with implantable drug delivery systems, e.g. Medtronic Synchromed.
• Patients with heart stents or metal implants such as pacemakers, automatic defibrillators, cochlear implants, aneurysm clips, vena cava clips and skull plates (Metal implants for orthopedic repair, e.g. pins, clips, plates, cages, joint replacements are allowed)
• Patients with a known history of myocardial infarction or ischemic heart disease within the past six months
• Prior celiac plexus block, or other neurolytic pain control treatment, within 1 month
• Other identified causes of painful parasthesias existing prior to chemotherapy (e.g., carpal tunnel syndrome, B12 deficiency, AIDS, monoclonal gammopathy, diabetes, heavy metal poisoning amyloidosis, syphilis, hyperthyroidism or hypothyroidism, inherited neuropathy, etc.) that might be responsible for the patient's current neuropathic symptoms
• Skin conditions such as open sores that would prevent proper application of the electrodes
• Patients with an ongoing concomitant central neurologic disorder or history of epilepsy, brain damage, or symptomatic brain metastases
• Other medical or other condition(s) that in the opinion of the investigators might compromise the objectives of the study

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Vishnevetsky A, Romanow G, Levy M. A transcutaneous electrical nerve stimulation device for the relief of neuropathic pain in NMOSD: A randomized, double-blind, sham-controlled trial. Mult Scler J Exp Transl Clin. 2024 Dec 5;10(4):20552173241301018. doi: 10.1177/20552173241301018. eCollection 2024 Oct-Dec.

  PMID: 39651334 DERIVED

MeSH Terms

Conditions

Neuromyelitis Optica

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Myelitis, Transverse; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Demyelinating Diseases; Eye Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Results Point of Contact

• Title: Michael Levy
• Organization: Massachusetts General Hospital

mlevy11@mgh.harvard.edu

6177267565

Study Officials

• Michael Levy, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Subjects will be randomized to either the intervention or the control group, fitted and trained to use the home TENS device to self-administer treatment for at least one hour each day. The subjects will not know to which arm they are randomized. Neither will the study coordinator or the investigator. Only a 3rd party collaborator will know the assignment scheme and this will be revealed in blocks every time 4 subjects complete the trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Patients will be randomized 1:1 to receive treatment daily for 4 consecutive weeks versus sham, followed by an open-label phase for additional 4 consecutive weeks.

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: November 4, 2020
• Study Start: June 7, 2021
• Primary Completion: April 13, 2022
• Study Completion: January 15, 2025
• Last Updated: April 30, 2025
• Results First Posted: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)