High Frequency Impulse Therapy for Neuromyelitis Optica (NMO)

Recruiting in Palo Alto (17 mi)

Overseen byMichael Levy, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Harvard Medical School (HMS and HSDM)

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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).

Eligibility Criteria

This trial is for adults with Neuromyelitis Optica (NMO) who have stable disease, no recent spinal cord relapses, and are on a consistent medication regimen. Participants must experience neuropathic pain from a spinal lesion, be positive for aquaporin-4 antibody, and not have had certain heart issues or other treatments that could affect the study.

Inclusion Criteria

Patient understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form

Your blood test must show that you have the aquaporin-4 antibody.

You have had ongoing nerve pain for more than 3 months and rate it as a 4 or higher on the pain scale with faces.

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Exclusion Criteria

Other medical or other condition(s) that in the opinion of the investigators might compromise the objectives of the study

You had a heart attack or heart disease in the last six months.

You have received a nerve block or other treatment for pain in the past month.

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Participant Groups

The trial tests if using an electrical nerve stimulating device at home can help relieve long-term (>3 months) neuropathic pain in NMO patients. It compares real High Frequency Impulse Therapy to a sham (fake) treatment to see if there's a difference in effectiveness.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Experimental armExperimental Treatment1 Intervention

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.

Group II: Sham armPlacebo Group1 Intervention

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.