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Scrambler Therapy for Neuropathic Pain (ST-CBS Trial)
N/A
Recruiting
Led By Alexander Pantelyat, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Men and women, ≥50 years of age with CBS and an average daily pain rating of > 4 out of 10 using the Brief Pain Inventory
Ability to understand the study regimen, its requirements, risks, and discomforts, and willingness to sign an informed consent form
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 to day 30 and 90
Awards & highlights
ST-CBS Trial Summary
This trial tests if a new therapy (ST) can reduce pain in people w/ corticobasal syndrome. Patients are randomly assigned TENS or ST, ECG electrodes placed, & treatment until relief is obtained. Results will show if ST is an effective pain relief option.
Who is the study for?
This trial is for English-speaking men and women over 50 with corticobasal syndrome (CBS) who experience daily pain above a moderate level. They must understand the study, agree to participate, and have a life expectancy of more than 90 days. It's not for pregnant or nursing women, those with certain metal implants, heart conditions, epilepsy, skin issues affecting electrode placement, or anyone using investigational pain agents recently.Check my eligibility
What is being tested?
The trial is testing scrambler therapy (ST), comparing it to transcutaneous electrical nerve stimulation (TENS) for treating neuropathic pain in CBS patients. Participants will be randomly assigned to receive either ST or TENS first; all will eventually get ST. The treatment involves placing ECG electrodes on painful areas for up to 40 minutes.See study design
What are the potential side effects?
While specific side effects are not listed here, typical risks may include discomfort at the electrode application site and potential skin irritation from the adhesive used in both TENS and ST treatments.
ST-CBS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 50 or older with chronic back pain, averaging more than 4 out of 10.
Select...
I understand the study's demands and risks and am willing to consent.
ST-CBS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 0 to day 30 and 90
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 to day 30 and 90
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in patient-reported average daily pain using the Modified Brief Pain Index
Secondary outcome measures
Change in patient-reported Global Impression of Change (PGIC)
ST-CBS Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Scrambler therapyExperimental Treatment1 Intervention
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.
Group II: TENS treatmentActive Control1 Intervention
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Neuropathic pain treatments like Scrambler Therapy (ST) and transcutaneous electrical nerve stimulation (TENS) work by using non-invasive electrical stimulation to modulate pain signal transmission. These therapies aim to disrupt the abnormal pain signals sent to the brain by introducing new, non-painful signals, effectively 'scrambling' the pain messages.
This mechanism is crucial for neuropathic pain patients as it offers a non-pharmacologic option to manage pain, potentially reducing reliance on medications and their associated side effects. By altering the way pain is perceived, these treatments can improve quality of life and functional outcomes for patients suffering from chronic neuropathic pain.
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Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,275 Previous Clinical Trials
14,840,613 Total Patients Enrolled
1 Trials studying Neuropathic Pain
90 Patients Enrolled for Neuropathic Pain
Alexander Pantelyat, MDPrincipal InvestigatorDepartment of Neurology, Johns Hopkins School of Medicine
6 Previous Clinical Trials
151 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your doctor believes you will live longer than 90 days.You have a medical condition that could affect the study goals.I haven't used experimental pain medication in the last 30 days.I do not have open sores that would interfere with using electrodes.I have not had a heart attack or heart disease in the last 6 months.You have a device inside your body that delivers medication.You have heart stents or certain metal implants in your body, except for metal implants used for orthopedic repair.I am 50 or older with chronic back pain, averaging more than 4 out of 10.I have a history of epilepsy, brain damage, or brain cancer spread.I understand the study's demands and risks and am willing to consent.I am proficient in English.
Research Study Groups:
This trial has the following groups:- Group 1: TENS treatment
- Group 2: Scrambler therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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