Scrambler Therapy for Pain in Corticobasal Syndrome

This study is testing if Scrambler therapy (a non-invasive electrical treatment) can help reduce neuropathic pain in people with corticobasal syndrome (CBS), a rare brain disorder. Participants, aged 50 to 89, must have an average daily pain rating of more than 4 out of 10. You would be randomly assigned to receive either Scrambler therapy or TENS treatment (another electrical pain therapy) first. The main goal is to see if Scrambler therapy reduces pain scores by at least 33% after one month, which would support further research. The study plans to enroll 25 people, but its current status is unclear.

Study design
This is an interventional study with 25 planned participants. You will be randomly assigned to receive either Scrambler therapy or TENS treatment.
What's involved
You will have superficial electrodes placed on your skin in the painful areas. Each treatment session will last 30-40 minutes or until your pain is relieved.
Compensation
Not stated in the trial record.
Follow-up
Your pain levels will be measured at Day 0, Day 30, and Day 90 after starting treatment.

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NCT05653778

Scrambler Therapy for Corticobasal Syndrome-Associated Pain

Recruiting
NAAges 50–89InterventionalTreatment
Johns Hopkins University
~25 participants
Updated 2026-01-13 on ClinicalTrials.gov
What's tested:Scrambler therapyTENS treatment

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in patient-reported average daily pain using the Modified Brief Pain Index
Measured over Day 0 to Day 30 and 90
Corticobasal Degeneration
Corticobasal Syndrome
Pain, Neuropathic
1 sites across 1 states
Maryland1
  • Alexander Pantelyat, MD · PRINCIPAL_INVESTIGATOR · Department of Neurology, Johns Hopkins School of Medicine

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Eligibility criteria

Inclusion

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

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.
  • Change in patient-reported average daily pain using the Modified Brief Pain IndexDay 0 to Day 30 and 90

    The primary objective is to determine the change in patient-reported average daily pain from Day 0 to Day 30 and 90 as measured on a numerical scale of 0-10 (0=no pain; 10=worst pain in life) using the Modified Brief Pain Index.