Scrambler Therapy for Corticobasal Syndrome-Associated Pain

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 89
Healthy Volunteers: f
View:

• 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.

Locations
United States
Maryland
Johns Hopkins School of Medicine
RECRUITING
Baltimore
Contact Information
Primary
Alexander Pantelyat, MD
apantel1@jhmi.edu
410-502-3290
Backup
Maria Schmidt, CRNP
mschmi61@jhmi.edu
410-502-0133
Time Frame
Start Date: 2024-04-05
Estimated Completion Date: 2026-12
Participants
Target number of participants: 25
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov