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Behavioural Intervention

Scrambler Therapy for Post-Stroke Pain

Phase 4
Recruiting
Led By Dawn Merbach, MNP
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 over the age of 18 with ischemic or hemorrhagic stroke seen on imaging and a positive finding for pain in the area(s) affected by their stroke location
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial will compare Scrambler Therapy to traditional drugs for treating post-stroke pain in stroke patients.

Who is the study for?
This trial is for adults over 18 who've had a stroke at least one month ago and are now experiencing pain due to the stroke. They must have evidence of ischemic or hemorrhagic stroke on imaging with related pain. People with transient ischemic attacks, no MRI evidence of stroke, implanted devices like pacemakers, recent heart attacks, uncontrolled epilepsy, or brain metastases can't join.Check my eligibility
What is being tested?
The study compares Scrambler Therapy—a device aiming to 'scramble' pain signals—with standard medication management for post-stroke pain relief. Participants will be assigned to receive either this new therapy or continue with their usual drug treatments.See study design
What are the potential side effects?
Scrambler Therapy may cause skin irritation where pads are placed and temporary discomfort during treatment sessions. Standard medications' side effects vary based on the drugs used but often include drowsiness, nausea, constipation, and potential risk of addiction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am over 18 and have had a stroke confirmed by imaging, with pain in the affected area.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pain

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Scrambler Therapy Group 5 sessionsExperimental Treatment1 Intervention
Patients undergoing treatment by Scrambler Therapy will begin by describing the areas and levels of pain along the Numerical Rating Scale (NRS) from 0-10. After the Scrambler treatment, patients will again be asked to describe the areas and levels of pain using the NRS. Each patient undergoing Scrambler Therapy will undergo this process for 5 consecutive days, following the same procedure every day of treatment. After completion of treatment, participants will be asked to complete monthly ratings of their pain for three months, and to follow-up in clinic at 3-6 month intervals (standard of care).
Group II: Scrambler Therapy Group 10 sessionsActive Control1 Intervention
Patients undergoing treatment by Scrambler Therapy will begin by describing the areas and levels of pain along the Numerical Rating Scale (NRS) from 0-10. After the Scrambler treatment, patients will again be asked to describe the areas and levels of pain using the NRS. Each patient undergoing Scrambler Therapy will undergo this process for 10 consecutive days, following the same procedure every day of treatment. After completion of treatment, participants will be asked to complete monthly ratings of their pain for three months, and to follow-up in clinic at 3-6 month intervals (standard of care).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Scrambler Therapy
2015
N/A
~40

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,266 Previous Clinical Trials
14,837,457 Total Patients Enrolled
Dawn Merbach, MNPPrincipal InvestigatorJohns Hopkins University

Media Library

Scrambler Therapy (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05563038 — Phase 4
Post Stroke Pain Research Study Groups: Scrambler Therapy Group 5 sessions, Scrambler Therapy Group 10 sessions
Post Stroke Pain Clinical Trial 2023: Scrambler Therapy Highlights & Side Effects. Trial Name: NCT05563038 — Phase 4
Scrambler Therapy (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05563038 — Phase 4

Frequently Asked Questions

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

How many people have been enrolled in this clinical experiment?

"Affirmative. According to clinicaltrials.gov, this health experiment is still seeking volunteers since it was initially shared on May 15th 2023 and edited for the last time on June 13th of the same year. There are 40 places available at one trial centre."

Answered by AI

Are there any opportunities for volunteers to join this research endeavor?

"Affirmative. According to the information available on clinicaltrials.gov, this investigation is presently recruiting participants since it was posted in May 15th 2023 and updated last June 13th 2023. 40 people are expected to enroll from a single medical facility."

Answered by AI

Has the Scrambler Therapy Group gained clearance from the FDA?

"This treatment has been granted approval, so it was scored a 3 on our safety scale."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Scrambler Therapy for Post-Stroke Pain
2023. "Scrambler Therapy for Post-Stroke Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05563038.
~25 spots leftby Dec 2025
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