High Frequency Impulse Therapy for Neuromyelitis Optica (NMO)

Overseen By Gabriela M Romanow

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Harvard Medical School (HMS and HSDM)

Must be taking: Anti-epileptic, Antidepressant, NSAIDs

Must not be taking: Investigational agents

Disqualifiers: Pregnancy, Heart disease, Metal implants, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

46 Participants Needed

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).

Research Team

Michael Levy, MD, PhD

Principal Investigator

Massachusetts General Hospital

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use a TENS device for 1 hour per day for 4 weeks to manage neuropathic pain

4 weeks

At-home treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

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

Trial Overview 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.

Participant Groups

Group I: Experimental arm Experimental Treatment 1 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 arm Placebo Group 1 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.

Who Is Running the Clinical Trial?

Harvard Medical School (HMS and HSDM)

Lead Sponsor

Trials

208

Recruited

1,421,000+

Harvard Medical School

Lead Sponsor

Trials

30

Recruited

40,700+

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+