Scrambler Therapy for Corticobasal Syndrome-Associated Pain (ST-CBS)
Corticobasal Degeneration, Corticobasal Syndrome, Pain, Neuropathic
About this trial
This is an interventional treatment trial for Corticobasal Degeneration focused on measuring Corticobasal Degeneration, scrambler therapy, Corticobasal syndrome, neuropathic pain, neuropathy
Eligibility Criteria
Inclusion Criteria: men and women, ≥50 years of age or older with CBS with an average daily pain rating of > 4 out of 10, using the following question from the Brief Pain Inventory: "Please rate your pain by circling the one number that best describes your (abdominal) pain/discomfort on average over the past week. (Scale 0-10; 0= No pain, 10= Pain as bad as you can imagine) English speakers or English proficiency They must have a life expectancy > 90 days per their treating neurologist. The patient must be able to understand the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form. Exclusion Criteria: 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, surgical sterilization, subcutaneous implants, abstinence, etc.). Other exclusions include the following: 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; Patients with implantable drug delivery systems, e.g. Medtronic Synchromed, baclofen pumps. 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). Medical exclusions include: patients with a history of myocardial infarction or ischemic heart disease within the past six months; patients with history of epilepsy, brain damage, or symptomatic brain metastases; skin conditions such as open sores that would prevent proper application of the electrodes; or other medical or other condition(s) that in the opinion of the investigators might compromise the objectives of the study.
Sites / Locations
- Johns Hopkins School of Medicine
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Scrambler therapy
TENS treatment
Scrambler Therapy is a non-invasive neuromodulation approach using superficial electrocardiogram (ECG) electrodes in paired channels on the involved dermatomes to send "non-pain" information along the existing nerve pathways, which can modify peripheral and central sensitization.
Transcutaneous electrical nerve stimulation (TENS) is a battery-powered device which delivers low-voltage electrical current through superficial electrocardiogram (ECG) electrodes placed on the surface of the skin to provide pain relief.