NCT05563038

Brief Summary

The Investigators will enroll patients who have had a stroke and are experiencing post-stroke pain secondary to their infarct and disruption of the sensory system in a research study to compare the effectiveness of Scrambler Therapy to traditional pharmacologic therapies.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
19mo left

Started May 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
May 2023Dec 2027

First Submitted

Initial submission to the registry

September 28, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 3, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

May 15, 2023

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

4.6 years

First QC Date

September 28, 2022

Last Update Submit

January 23, 2026

Conditions

Post Stroke Pain

Outcome Measures

Primary Outcomes (1)

  • Reduction in post stroke pain

    At least a 50% reduction in post stroke pain

    6 months

Study Arms (1)

Scrambler Therapy

ACTIVE COMPARATOR

Using Scrambler Therapy for Post Stroke Pain all participants will either undergo either 5 or 10 treatments using Scrambler Therapy. The number of treatments will be decided by a randomization process.

Device: Scrambler Therapy for Post Stroke Pain

Interventions

Scrambler Therapy for Post Stroke PainDEVICE

All participants will either undergo either 5 or 10 treatments using Scrambler Therapy. The number of treatments will be decided by a randomization process.

Scrambler Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 will be included.
  • The patients must be at least one month post-stroke but can otherwise enroll at any point.

You may not qualify if:

  • Patients with TIA
  • Patients with no evidence of stroke on MRI
  • Patients with implantable devices such as pacemakers, defibrillators, spinal cord stimulators
  • Patients with history of myocardial infarction in the past 6 months
  • Patients with uncontrolled epilepsy
  • Patients with symptomatic brain metastases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Bayview Hospital

Baltimore, Maryland, 21224, United States

RECRUITING

Study Officials

  • Dawn Merbach, MNP

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dawn Merbach, MNP

CONTACT

4105508065dmerbac1@jhmi.edu

Erin Lawrence, MSN

CONTACT

4105508065ekilby1@jhmi.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Scrambler Group and Non-scrambler group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2022

First Posted

October 3, 2022

Study Start

May 15, 2023

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

January 26, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)