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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a special device used at home can relieve nerve pain for individuals with Neuromyelitis Optica Spectrum Disorder (NMOSD). The device, called High Frequency Impulse Therapy, sends electrical signals to the nerves and is used daily for four weeks. Participants will use either the actual device or a sham device that looks identical but does not send signals. Suitable candidates for this trial are those with NMOSD who have experienced persistent nerve pain for more than three months and have not had a spinal cord relapse in the past six months. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

You need to be on a stable medication regimen, which can include anti-epileptic, antidepressant, or non-steroidal anti-inflammatory medications, without any changes for 30 days before joining the trial. If your current medications fit this requirement, you won't need to stop them.

What prior data suggests that this transcutaneous electrical nerve stimulating device is safe for use in patients with Neuromyelitis optica spectrum disorder?

Research has shown that High Frequency Impulse Therapy is under study for its potential to ease nerve pain in people with Neuromyelitis Optica Spectrum Disorder (NMOSD). Previous patients have generally tolerated this therapy well.

Other studies have not specifically reported serious side effects linked to this therapy. It is important to note that this is a Phase 2 trial, which usually indicates that the treatment's safety has already been tested in smaller groups. While this does not guarantee the absence of side effects, it suggests the treatment is likely safe for people. Always consult a healthcare provider for personal advice about joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for NMO?

High Frequency Impulse Therapy is unique because it uses targeted electrical impulses to address pain associated with Neuromyelitis Optica (NMO). Unlike traditional treatments that often rely on immunosuppressive drugs, this therapy focuses on providing pain relief through transcutaneous electrical nerve stimulation (TENS). Researchers are excited because this method could offer a non-pharmacological option that reduces side effects and improves quality of life by targeting pain at its source. Additionally, the potential for rapid pain relief within a few weeks makes it an appealing alternative to current long-term medication regimens.

What evidence suggests that this device is effective for neuropathic pain in NMOSD?

Research shows that High Frequency Impulse Therapy, which participants in this trial may receive, might help ease nerve pain in people with Neuromyelitis Optica Spectrum Disorder (NMOSD). This therapy uses a device that sends electrical signals to the nerves. In earlier studies, people using similar devices reported feeling less pain over time. These devices block pain signals from reaching the brain, reducing the sensation of pain. Although more research is needed, early results suggest this therapy could be a promising way to manage long-term pain in NMOSD. Participants in this trial may also receive a sham version of the therapy, which looks identical but does not deliver an electric current. ^{1 2 5 6 7}

Who Is on the Research Team?

Michael Levy, MD, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04614454

High Frequency Impulse Therapy for Neuropathic Pain in ... The aim of this study is to determine whether self-administered, at-home use of a transcutaneous electrical nerve stimulating device is an effective, ...

2. withpower.com withpower.com/trial/phase-3-neuromyelitis-optica-5-2021-05a6a

High Frequency Impulse Therapy for Neuromyelitis Optica ... 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.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10770020/

Update on the diagnosis and treatment of neuromyelitis optica ... This manuscript presents practical recommendations for managing acute attacks and implementing preventive immunotherapies for neuromyelitis optica spectrum ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1878747923009406

Present and Future Therapies in Neuromyelitis Optica ... In this review, we will discuss present and future immunotherapies for NMOSD and also consider combination of treatments, plasma, cellular and other therapies.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6172906/

Treatment strategies for neuromyelitis optica - PMC To date, no acute therapy has demonstrated significant benefits in improving visual outcomes in patients with NMO or in preventing optic nerve atrophy [8].

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4229040/

Treatment of neuromyelitis optica: state-of-the-art and ... The data supporting the clinical benefit of IVIg in NMO are limited. In one study, IVIg showed efficacy in the prevention of relapses in eight NMO patients, ...

7. link.springer.com link.springer.com/article/10.1007/s00415-023-11910-z

Update on the diagnosis and treatment of neuromyelitis ... This manuscript presents practical recommendations for managing acute attacks and implementing preventive immunotherapies for neuromyelitis optica spectrum ...