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Scrambler Therapy for Corticobasal Syndrome-Associated Pain (ST-CBS)

Primary Purpose

Corticobasal Degeneration, Corticobasal Syndrome, Pain, Neuropathic

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Scrambler therapy
TENS treatment
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Corticobasal Degeneration focused on measuring Corticobasal Degeneration, scrambler therapy, Corticobasal syndrome, neuropathic pain, neuropathy

Eligibility Criteria

50 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Johns Hopkins School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Scrambler therapy

TENS treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in patient-reported Global Impression of Change (PGIC)
Changes in the Patient Global Impression of Change score 1 to 7 with 1 representing no change and 7 representing "a great deal better"

Full Information

First Posted
November 29, 2022
Last Updated
October 10, 2023
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT05653778
Brief Title
Scrambler Therapy for Corticobasal Syndrome-Associated Pain
Acronym
ST-CBS
Official Title
Scrambler Therapy for Corticobasal Syndrome-Associated Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 15, 2023 (Anticipated)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Pain can be a common non-motor complication of corticobasal syndrome (CBS), which is a rare debilitating parkinsonian disorder that lacks disease-modifying therapies. Pain in CBS typically increases in severity as the disease progresses and adversely impacts quality of life (including sleep and daily function). Scrambler therapy is a non-invasive electrical approach to neuromodulation that sends "nonpain" information along the existing nerve pathways to modify peripheral and central sensitization with success in randomized controlled trials treating such difficult neuropathies as spinal cord stenosis, post-herpetic neuropathy and failed back syndrome; chemotherapy induced neuropathy; and neuromyelitis optica spectrum disorder (NMOSD). To date, four patients with CBS treated empirically with ST have experienced long lasting pain relief with treatment, suggesting a novel approach to a vexing symptom. An estimated 35-80% of patients with Parkinson disease experience pain and it is highly likely that pain is more frequent in CBS, though estimates are lacking because CBS is a rare syndrome. This pain can be related to dystonia, musculoskeletal, radicular-peripheral neuropathic, and central neuropathic pain syndromes. Similar symptoms are found in patients with CBS. Currently, there are no FDA approved disease-modifying treatments. Although treatments for pain have been helpful, ultimately adjunct therapies are needed as the disease progresses. A simple, low-cost, non-invasive available treatment to reduce the pain of CBS is sorely needed. This pilot trial will provide data on which to design a larger randomized controlled trial. Research Hypothesis: Scrambler Therapy (ST) will reduce pain scores by at least 33% at one month in this pilot trial, justifying further multi-center trials.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corticobasal Degeneration, Corticobasal Syndrome, Pain, Neuropathic
Keywords
Corticobasal Degeneration, scrambler therapy, Corticobasal syndrome, neuropathic pain, neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomly assigned scrambler therapy or TENS treatment to patients.
Masking
Participant
Masking Description
Patients will be masked on whether they will receive scrambler therapy or TENS treatment for neuropathic pain.
Allocation
Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Scrambler therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
TENS treatment
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Scrambler therapy
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
TENS treatment
Intervention Description
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 Information:
Title
Change in patient-reported average daily pain using the Modified Brief Pain Index
Description
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.
Time Frame
Day 0 to Day 30 and 90
Secondary Outcome Measure Information:
Title
Change in patient-reported Global Impression of Change (PGIC)
Description
Changes in the Patient Global Impression of Change score 1 to 7 with 1 representing no change and 7 representing "a great deal better"
Time Frame
Day 0, Day 30 and Day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Pantelyat, MD
Phone
410-502-3290
Email
apantel1@jhmi.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Schmidt, CRNP
Phone
410-502-0133
Email
mschmi61@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Pantelyat, MD
Organizational Affiliation
Department of Neurology, Johns Hopkins School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Pantelyat, MD
Phone
410-502-3290
Email
apantel1@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Maria Schmidt, CRNP
Phone
410-502-0133
Email
mschmi61@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Thomas J Smith, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Scrambler Therapy for Corticobasal Syndrome-Associated Pain

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