High Frequency Impulse Therapy for Neuropathic Pain in NMOSD
Neuromyelitis Optica
About this trial
This is an interventional treatment trial for Neuromyelitis Optica
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
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Experimental arm
Sham arm
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.
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.