Scrambler Therapy for Corticobasal Syndrome-Associated Pain

Launched by JOHNS HOPKINS UNIVERSITY · Dec 7, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring whether a treatment called scrambler therapy (ST) can help reduce neuropathic pain in patients with corticobasal syndrome (CBS). The main goal is to see if patients experience at least a 33% reduction in their pain levels after one month of receiving therapy. Participants in the study, who are adults aged 50 and older with ongoing pain rated as above 4 out of 10, will be randomly assigned to receive either ST or another treatment called transcutaneous electrical nerve stimulation (TENS). Eventually, all participants will receive ST, which involves having small pads placed on their skin to deliver gentle electrical signals to help relieve pain.

To be eligible, participants must be English speakers with a life expectancy of more than 90 days, and they should be able to understand and agree to the study requirements. Those with certain medical conditions or devices, like heart stents or metal implants, will not be able to join the study. If you or a loved one is interested in participating, you can expect treatments lasting 30 to 40 minutes, during which the researchers will monitor your pain relief. This trial is important because if scrambler therapy proves effective, it could lead to larger studies that might offer new hope for managing pain in patients with CBS.

Gender

ALL

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.