Actively Recruiting
Scrambler Therapy for Corticobasal Syndrome-Associated Pain
Led by Johns Hopkins University · Updated on 2026-01-13
25
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether scrambler therapy (ST) can effectively reduce neuropathic pain in patients with corticobasal syndrome (CBS), a rare and progressive parkinsonian disorder that causes severe pain impacting quality of life. This pilot trial aims to determine if ST can lower pain scores by at least 33% within one month, which would support further larger studies. CBS currently has no disease-modifying treatments, making pain management an urgent need. Participants will be randomly assigned to receive either scrambler therapy or transcutaneous electrical nerve stimulation (TENS) initially, with all eventually receiving scrambler therapy. Both treatments use superficial electrocardiogram (ECG) electrodes placed on the areas of pain, delivering electrical stimulation for 30 to 40 minutes or until pain relief occurs. Scrambler therapy sends "non-pain" signals to modify nerve pathways, while TENS uses low-voltage current for pain relief. During the study, participants will have their pain levels monitored using patient-reported measures such as the Modified Brief Pain Index and the Patient Global Impression of Change over 30 and 90 days. Researchers will assess changes in daily pain and overall improvement. The trial includes safety monitoring and informed consent, with participation lasting at least three months and follow-up assessments to evaluate treatment effects and pain relief.
CONDITIONS
Brief Title
Scrambler Therapy for Corticobasal Syndrome-Associated Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 50 years or older with corticobasal syndrome
- Average daily pain rating greater than 4 out of 10 based on the Brief Pain Inventory
- English speakers or those proficient in English
- Life expectancy greater than 90 days as determined by treating neurologist
- Able to understand study procedures, risks, and willing to sign informed consent
You will not qualify if you...
- Pregnant or nursing women, women of childbearing potential or their sexual partners unwilling to use adequate contraception
- Use of investigational pain agents concurrently or within past 30 days
- History of allergic reaction or intolerance to transcutaneous electrical nerve stimulation
- Presence of implantable drug delivery systems such as Medtronic Synchromed or baclofen pumps
- Presence of heart stents or metal implants like pacemakers, defibrillators, cochlear implants, aneurysm clips, vena cava clips, or skull plates (orthopedic metal implants allowed)
- History of myocardial infarction or ischemic heart disease within past six months
- History of epilepsy, brain damage, or symptomatic brain metastases
- Skin conditions such as open sores preventing electrode application
- Any other medical or condition judged by investigators to compromise study objectives
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 days
Participants receive either Scrambler therapy or TENS treatment using superficial ECG electrodes placed on the skin over areas of pain. Each treatment lasts 30 to 40 minutes or until pain relief is obtained.
Daily visits for up to 10 treatment sessions
Duration - 60 days
Participants are monitored to assess changes in pain and overall impression of change after treatment.
2 visits (Day 30 and Day 90)
Trial Site Locations
Total: 1 location
1
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21205
Actively Recruiting
Research Team
A
Alexander Pantelyat, MD
M
Maria Schmidt, CRNP
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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