Using scrambler therapy to treat pain in corticobasal syndrome
Scrambler Therapy for Corticobasal Syndrome-Associated Pain
NA · Johns Hopkins University · NCT05653778
This study is testing if scrambler therapy can help reduce nerve pain in people with corticobasal syndrome.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 50 Years to 89 Years |
| Sex | All |
| Sponsor | Johns Hopkins University (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT05653778 on ClinicalTrials.gov |
What this trial studies
This pilot trial aims to evaluate the effectiveness of scrambler therapy (ST) in reducing neuropathic pain in patients with corticobasal syndrome (CBS). Participants will be randomly assigned to receive either transcutaneous electrical nerve stimulation (TENS) or ST, with the goal of achieving at least a 33% reduction in pain scores after one month. The treatment involves placing superficial ECG electrodes on the affected dermatomes and administering therapy for 30-40 minutes or until pain relief is achieved. The study seeks to determine if ST can provide significant pain relief, justifying further multi-center trials.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 50 and older with corticobasal syndrome experiencing an average daily pain rating greater than 4 out of 10.
Not a fit: Patients who are pregnant, nursing, or of childbearing potential without adequate contraception may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could offer a new, non-invasive treatment option for managing pain in patients with corticobasal syndrome.
How similar studies have performed: Previous studies have shown success with scrambler therapy in treating various neuropathic pain conditions, suggesting potential for this novel application.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Baltimore, Maryland
- Johns Hopkins School of Medicine — Baltimore, Maryland, United States (RECRUITING)
Study contacts
- Principal investigator: Alexander Pantelyat, MD — Department of Neurology, Johns Hopkins School of Medicine
- Study coordinator: Alexander Pantelyat, MD
- Email: apantel1@jhmi.edu
- Phone: 410-502-3290
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Corticobasal Degeneration, Corticobasal Syndrome, Pain, Neuropathic, scrambler therapy, Corticobasal syndrome, neuropathic pain, neuropathy