High Frequency Impulse Therapy for Neuropathic Pain in NMOSD
High Frequency Impulse Therapy for Neuropathic Pain in NMOSD
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- High Frequency Impulse Therapy
Placebo
- High Frequency Impulse Therapy - Sham
Results by group
Change in Pain Score on the Numerical Rating Score (NRS)
4 weeks from baseline to completion of the experimental phase.
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Experimental Arm | 2.2 units on a scale | 2.2 (Standard Deviation) | 19 |
| Sham Arm | 1.3 units on a scale | 2.3 (Standard Deviation) | 21 |
Experimental Arm
Sham Arm
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Experimental Arm | 23 | 0 (0.0%) | 0 |
| Sham Arm | 23 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Change in Pain Score on the Numerical Rating Score (NRS)
4 weeks from baseline to completion of the experimental phase.
Pain
Other measures (3)
"Worst" Pain Score on the NRS Scale
4 weeks from baseline to completion of the experimental phase.
PainWithdrawal From Trial
4 weeks from baseline to completion of the experimental phase.
Quality of Life Survey
4 weeks from baseline to completion of the experimental phase.
Quality of life (reported by participants)
Who could take part
NMOSD · 18 and over
Show the full criteria
Inclusion criteria
1. Men and women 18 years of age or older diagnosed with NMOSD per the 2015 NMOSD criteria 2. Patients must be positive for the aquaporin-4 antibody in serum. 3. Presence of persistent neuropathic pain (>3 months) rated at a level of 4 or higher on the Wong-Baker Faces Pain Scale 4. Patients must be stable in their disease, such that they have had no spinal cord relapses within 6 months prior to enrollment 5. 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 6. Pain must be localized to a spinal cord lesion 7. Patient understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form
Exclusion criteria
1. Patients who are cognitively or mentally incompetent 2. 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.). 3. Use of an investigational agent for pain control concurrently or within the past 30 days 4. History of an allergic reaction or previous intolerance to transcutaneous electronic nerve stimulation or to latex 5. Patients with implantable drug delivery systems, e.g. Medtronic Synchromed. 6. 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) 7. Patients with a known history of myocardial infarction or ischemic heart disease within the past six months 8. Prior celiac plexus block, or other neurolytic pain control treatment, within 1 month 9. 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 10. Skin conditions such as open sores that would prevent proper application of the electrodes 11. Patients with an ongoing concomitant central neurologic disorder or history of epilepsy, brain damage, or symptomatic brain metastases 12. Other medical or other condition(s) that in the opinion of the investigators might compromise the objectives of the study
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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).
Papers
Loading reviews and guidelines…
History
Started
Jun 2021
Main results due
Apr 2022
Finished
Jan 2025
Results posted
Apr 2025