RECRUITING

Scrambler Therapy for Corticobasal Syndrome-Associated Pain

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Scrambler Therapy for Corticobasal Syndrome-Associated Pain

Quick Facts

Study Start:2024-04-05
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05653778

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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)
  2. * English speakers or English proficiency
  3. * They must have a life expectancy \> 90 days per their treating neurologist.
  4. * 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.
  1. * 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:
  2. * Use of an investigational agent for pain control concurrently or within the past 30 days,
  3. * History of an allergic reaction or previous intolerance to transcutaneous electronic nerve stimulation;
  4. * Patients with implantable drug delivery systems, e.g. Medtronic Synchromed, baclofen pumps.
  5. * 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).
  6. * 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.

Contacts and Locations

Study Contact

Alexander Pantelyat, MD
CONTACT
410-502-3290
apantel1@jhmi.edu
Maria Schmidt, CRNP
CONTACT
410-502-0133
mschmi61@jhmi.edu

Principal Investigator

Alexander Pantelyat, MD
PRINCIPAL_INVESTIGATOR
Department of Neurology, Johns Hopkins School of Medicine

Study Locations (Sites)

Johns Hopkins School of Medicine
Baltimore, Maryland, 21205
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Alexander Pantelyat, MD, PRINCIPAL_INVESTIGATOR, Department of Neurology, Johns Hopkins School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-05
Study Completion Date2026-12

Study Record Updates

Study Start Date2024-04-05
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Corticobasal Degeneration
  • Corticobasal Syndrome
  • Pain, Neuropathic