Transcranial Magnetic Stimulation for Chronic Scrotal Content Pain
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Patient reported pain score on SMS text EMA system
Study Overview
Brief Summary
The purpose of this study is to perform an open label feasibility trial of TMS for the treatment of chronic scrotal content pain.
Detailed Description
The purpose of this study is to perform an open label feasibility trial of TMS for the treatment of chronic scrotal content pain. Participants will be screened by study staff for contraindications to TMS treatment. TMS will be delivered use the MagVenture TMS machine. TMS will be delivered during 15 minutes per session, 3 sessions each day, for 3 days. A custom developed SMS text EMA system will be used to gather daily data on pain and functioning in study participants.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male patients with chronic scrotal pain lasting for 6 or more months.
- •Pain must be present 3 or more days of the week.
Exclusion Criteria
- •No new pain medications within the last 30 days.
Arms & Interventions
Open label
Open label study. Participants will be screened by study staff for contraindications to TMS treatment. TMS will be delivered use the MagVenture TMS machine.
Intervention: Transcranial magnetic stimulation (Other)
Outcomes
Primary Outcomes
Patient reported pain score on SMS text EMA system
Time Frame: baseline, and post intervention (0 days, 1 week, 2 weeks, 1 month, 3 months, 6 months)
A custom developed SMS text EMA system will be used to gather daily data on pain
Secondary Outcomes
- Patient reported post procedure quality of life as measured on an SMS text EMA system(baseline, and post intervention (0 days, 1 week, 2 weeks, 1 month, 3 months, 6 months))
- Progression to other treatments(Within 6 months after completion)