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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 below

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I am 50 or older with chronic back pain, averaging more than 4 out of 10.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 to day 30 and 90 for reporting.

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,266 Previous Clinical Trials

14,837,472 Total Patients Enrolled

Alexander Pantelyat, MDPrincipal InvestigatorDepartment of Neurology, Johns Hopkins School of Medicine

6 Previous Clinical Trials

151 Total Patients Enrolled

Media Library

Scrambler Therapy (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05653778 — N/A

Cortical Basal Ganglionic Degeneration Research Study Groups: TENS treatment, Scrambler therapy

Cortical Basal Ganglionic Degeneration Clinical Trial 2023: Scrambler Therapy Highlights & Side Effects. Trial Name: NCT05653778 — N/A

Scrambler Therapy (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05653778 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do individuals below the age of thirty qualify for this medical trial?

"This study's parameters dictate that the youngest participant must be at least 18 years of age, while the oldest may not exceed 89."

Answered by AI

Are enrollment slots still available for this clinical investigation?

"This clinical study, initially posted on March 1st 2023, is not presently searching for candidates. The last update to the trial was made December 7th 2022. However, there are 1575 other medical trials that currently need patient participants at this time."

Answered by AI

Who qualifies to join this clinical trial?

"This medical trial requires 25 individuals with corticobasal degeneration aged 18 to 89. The most essential eligibility criteria are as follows: male or female, 50 years of age and over suffering from CBS with mean daily pain score above 4 out of 10 on the Brief Pain Inventory scale (0-10; 0= no pain, 10 = worst possible), fluency in English or ability to comprehend it, life expectancy exceeding 90 days according to the treating physician's evaluation, capacity for understanding study regimen, potential risks and discomforts inherent therewith, and willingness to sign informed consent form."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Scrambler Therapy for Corticobasal Syndrome-Associated Pain

2024. "Scrambler Therapy for Corticobasal Syndrome-Associated Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05653778.

All > Nerve Pain > Neuropathy