Scrambler Therapy for Post-Stroke Pain
Status: Recruiting
Location: See location...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Maryland
Johns Hopkins Bayview Hospital
RECRUITING
Baltimore
Contact Information
Primary
Dawn Merbach, MNP
dmerbac1@jhmi.edu
4105508065
Backup
Erin Lawrence, MSN
ekilby1@jhmi.edu
4105508065
Time Frame
Start Date: 2023-05-15
Estimated Completion Date: 2026-12
Participants
Target number of participants: 40
Treatments
Experimental: Scrambler Therapy Group 5 sessions
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).
Active_comparator: Scrambler Therapy Group 10 sessions
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).
Related Therapeutic Areas
Sponsors
Leads: Johns Hopkins University