Recruiting

Scrambler Therapy

Sponsor:

Johns Hopkins University

Code:

NCT05653778

Conditions

Corticobasal Degeneration

Corticobasal Syndrome

Pain, Neuropathic

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Scrambler therapy

TENS treatment

Study Details

Brief summary:

The goal of this pilot trial is to test whether scrambler therapy (ST) is an effective treatment for neuropathic pain in patients with corticobasal syndrome (CBS).

The main question it aims to answer is:

Will ST reduce pain scores by at least 33% at one month in this pilot trial, justifying further multi-center trials?

Participants will:

  • be randomly assigned treatment from either transcutaneous electrical nerve stimulation (TENS) or ST for pain initially (eventually all patients will receive ST).
  • have superficial electrocardiogram (ECG) electrodes placed on the dermatomes involved with pain
  • obtain treatment lasting 30-40 minutes or until pain relief is obtained

Researchers will compare patient's response to pain relief with TENS and ST to determine if ST is an effective treatment for central neuropathic pain.

Conditions

Corticobasal Degeneration

Corticobasal Syndrome

Pain, Neuropathic

Study ID

NCT05653778

Start date

Apr 5, 2024

Status verified date

Jan, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

25 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Scrambler therapy

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.

active comparator: TENS treatment

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.

Interventions

Scrambler therapy

Superficial electrocardiogram (ECG) electrodes are placed on the dermatomes involved with pain, above the area of pain itself. Each treatment lasts 30-40 minutes or until pain relief is obtained.

TENS treatment

Superficial electrocardiogram (ECG) electrodes are placed on the dermatomes involved with pain, above the area of pain itself. Each treatment lasts 30-40 minutes or until pain relief is obtained.

Primary outcome measure

  • Change in patient-reported average daily pain using the Modified Brief Pain Index [ Time Frame: Day 0 to Day 30 and 90 ]

Central Contacts and Locations

Central contacts

Alexander Pantelyat, MD

410-502-3290apantel1@jhmi.edu

Maria Schmidt, CRNP

410-502-0133mschmi61@jhmi.edu

Locations

Johns Hopkins School of Medicine

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Alexander Pantelyat, MD

410-502-3290apantel1@jhmi.edu

Maria Schmidt, CRNP

410-502-0133mschmi61@jhmi.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Jan 13, 2026

Last verified

Jan, 2026

Keywords

  • Corticobasal Degeneration
  • scrambler therapy
  • Corticobasal syndrome
  • neuropathic pain
  • neuropathy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-01-13.