Scrotal Pain
Conditions
Keywords
Scrotal pain, testicular pain, Transcranial magnetic stimulation
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.
Interventions
OTHERTranscranial magnetic stimulation
Resting motor threshold will be established by first finding the area of the motor cortex associated with visible twitch of the right abductor pollicis brevis (APB). Parameter Estimation by Sequential Testing (PEST) will be conducted to quantify resting motor threshold using visible APB twitch. The left dorsolateral prefrontal cortex (DLPFC) will be located using the Beam F3 method and marked with a felt-tipped marker on the scalp. TMS will be delivered over left DLPFC at 110% of resting motor threshold at 10Hz (5-seconds-on; 10-seconds-off) for 15 minutes per session (3000 pulses), 3 sessions each day (30-minute rest in-between sessions), for 3 days (within 5 consecutive days; a total of 27,000 pulses).
Sponsors
Medical University of South Carolina
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient reported pain score on SMS text EMA system | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | A custom developed SMS text EMA system will be used to gather daily data on pain |
| Progression to other treatments | Within 6 months after completion | Progression to other medical or surgical treatments |
Countries
United States
Contacts
CONTACTSolomon Hayon, MD
STUDY_DIRECTORJeffery Brockardt, Ph.D.
Medical University of South Carolina
Outcome results
None listed