Transcranial Magnetic Stimulation for Chronic Scrotal Content Pain

NCT07035119 | Not Yet Recruiting Phase 1

• 1 other identifier: Pro00140222
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Scrotal Pain

Keywords

Scrotal pain; testicular pain; Transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (2)

• 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

Study Arms (1)

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.

Other: Transcranial magnetic stimulation

Interventions

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).

Open label

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male (biological), with testis
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male patients with chronic scrotal pain lasting for 6 or more months.
• Pain must be present 3 or more days of the week.

You may not qualify if:

• No new pain medications within the last 30 days.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (5)

• 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.

  PMID: 24729198 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.

  PMID: 31824787 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.

  PMID: 32754451 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.

  PMID: 25240669 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.

  PMID: 31768134 BACKGROUND

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Jeffery Brockardt, Ph.D.

  Medical University of South Carolina

  STUDY DIRECTOR

Central Study Contacts

Solomon Hayon, MD

CONTACT

18437927888; hayon@musc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: June 24, 2025
• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)