Scrambler Therapy for Corticobasal Syndrome-Associated Pain

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT05653778
Status
Recruiting
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Conditions

  • Corticobasal Degeneration
  • Corticobasal Syndrome
  • Pain, Neuropathic

Eligibility Criteria

Sex
ALL
Age
50 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Scrambler therapy — DEVICE
    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 — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Apr 5, 2024
Status verified
Jan 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
25 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins School of MedicineBaltimoreMaryland21205
Alexander Pantelyat, MD
[email protected]
410-502-3290
Maria Schmidt, CRNP
[email protected]
410-502-0133
Thomas J Smith, MD (SUB_INVESTIGATOR)

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By research site
Johns Hopkins School of Medicine· Baltimore, MD

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