High Frequency Impulse Therapy for Neuromyelitis Optica (NMO)

Phase 2

Waitlist Available

Led By Michael Levy, MD, PhD

Research Sponsored by Harvard Medical School (HMS and HSDM)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks from baseline to completion of the experimental phase.

Summary

This trial looks at whether a self-administered electrical nerve stimulator can help relieve neuropathic pain for people with NMOSD.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include skin irritation where the device is applied, muscle twitching during use of the device, discomfort or increased pain if settings are too high, and possible allergic reactions to materials like latex used in electrodes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks from baseline to completion of the experimental phase.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks from baseline to completion of the experimental phase.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks from baseline to completion of the experimental phase. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain score on the Numerical Rating Score (NRS)

Secondary study objectives

"Worst" pain score on the NRS scale

Pain score on the NRS in the extension phase

Quality of life survey

+1 more

Trial Design

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.

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