NCT04614454CompletedPhase 2
High Frequency Impulse Therapy for Neuropathic Pain in NMOSD
Source: ClinicalTrials.gov · Last updated 30 Apr 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 46 (actual)
- First submitted
- 22 Oct 2020
- Start date
- 7 Jun 2021
- Primary completion date
- 13 Apr 2022
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Neuromyelitis optica (NMOSD)
- NCT number
- NCT04614454
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 46
- From 7 Jun 2021 to the primary completion date, 13 Apr 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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
- Patients with an ongoing concomitant central neurologic disorder or history of epilepsy, brain damage, or symptomatic brain metastases
Other illness
- 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
- Skin conditions such as open sores that would prevent proper application of the electrodes
- Other medical or other condition(s) that in the opinion of the investigators might compromise the objectives of the study
Other
- Patients who are cognitively or mentally incompetent
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.