Phase 2
N=46
High Frequency Impulse Therapy for Neuropathic Pain in NMOSD
Neuromyelitis Optica
Bottom Line
View on ClinicalTrials.gov: NCT04614454 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Change in Pain Score on the Numerical Rating Score (NRS) — 2.2; 1.3 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- High Frequency Impulse Therapy (Device); High Frequency Impulse Therapy - Sham (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain Score on the Numerical Rating Score (NRS) |
2.2; 1.3 | — |
| SECONDARY "Worst" Pain Score on the NRS Scale |
1.0; 1.4 | — |
| SECONDARY Withdrawal From Trial |
4; 2 | — |
| SECONDARY Quality of Life Survey |
14.7; 10.2 | — |
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).
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04614454). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.