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The purpose of this study is to perform an open label feasibility trial of TMS for the treatment of chronic scrotal content pain.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open label | Experimental | Open label study. Participants will be screened by study staff for contraindications to TMS treatment. TMS will be delivered use the MagVenture TMS machine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial magnetic stimulation | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Patient reported pain score on SMS text EMA system | A custom developed SMS text EMA system will be used to gather daily data on pain | baseline, and post intervention (0 days, 1 week, 2 weeks, 1 month, 3 months, 6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient reported post procedure quality of life as measured on an SMS text EMA system | A custom developed SMS text EMA system will be used to gather daily data on pain | baseline, and post intervention (0 days, 1 week, 2 weeks, 1 month, 3 months, 6 months) |
| Progression to other treatments |
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Inclusion Criteria:
Exclusion Criteria:
Male (biological), with testis
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Solomon Hayon, MD | Contact | 18437927888 | hayon@musc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jeffery Brockardt, Ph.D. | Medical University of South Carolina | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24729198 | Background | O'Connell NE, Wand BM, Marston L, Spencer S, Desouza LH. Non-invasive brain stimulation techniques for chronic pain. Cochrane Database Syst Rev. 2014 Apr 11;(4):CD008208. doi: 10.1002/14651858.CD008208.pub3. | |
| 31824787 | Background | Hamid P, Malik BH, Hussain ML. Noninvasive Transcranial Magnetic Stimulation (TMS) in Chronic Refractory Pain: A Systematic Review. Cureus. 2019 Oct 29;11(10):e6019. doi: 10.7759/cureus.6019. |
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Based on internal IRB submission, IPD will not be shared
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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|
Progression to other medical or surgical treatments |
| Within 6 months after completion |
| 32754451 | Background | Parekattil SJ, Ergun O, Gudeloglu A. Management of Chronic Orchialgia: Challenges and Solutions - The Current Standard of Care. Res Rep Urol. 2020 Jul 2;12:199-210. doi: 10.2147/RRU.S198785. eCollection 2020. |
| 25240669 | Background | Young NA, Sharma M, Deogaonkar M. Transcranial magnetic stimulation for chronic pain. Neurosurg Clin N Am. 2014 Oct;25(4):819-32. doi: 10.1016/j.nec.2014.07.007. Epub 2014 Aug 12. |
| 31768134 | Background | Ziegelmann MJ, Farrell MR, Levine LA. Evaluation and Management of Chronic Scrotal Content Pain-A Common Yet Poorly Understood Condition. Rev Urol. 2019;21(2-3):74-84. |