Scrambler Therapy for Corticobasal Syndrome-Associated Pain

NCT05653778 | Recruiting FDA Device

• 1 other identifier: IRB00343996
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in patient-reported average daily pain using the Modified Brief Pain Index

  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.

  Day 0 to Day 30 and 90

Secondary Outcomes (1)

• Change in patient-reported Global Impression of Change (PGIC)

  Day 0, Day 30 and Day 90

Study Arms (2)

Scrambler therapy

EXPERIMENTAL

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.

Device: Scrambler therapy

TENS treatment

ACTIVE COMPARATOR

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.

Device: TENS treatment

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.

Scrambler therapy

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.

TENS treatment

Eligibility Criteria

• Age: 50 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins School of Medicine

Baltimore, Maryland, 21205, United States

RECRUITING

MeSH Terms

Conditions

Corticobasal Degeneration; Neuralgia

Condition Hierarchy (Ancestors)

Tauopathies; Neurodegenerative Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexander Pantelyat, MD

  Department of Neurology, Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Pantelyat, MD

CONTACT

410-502-3290; apantel1@jhmi.edu

Maria Schmidt, CRNP

CONTACT

410-502-0133; mschmi61@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will be masked on whether they will receive scrambler therapy or TENS treatment for neuropathic pain.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomly assigned scrambler therapy or TENS treatment to patients.

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: December 16, 2022
• Study Start: April 5, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)