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NCT Number: NCT07035119

Transcranial Magnetic Stimulation for 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.

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Key information

Conditions

Scrotal Pain

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. 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

  1. Patient reported post procedure quality of life as measured on an 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

  2. Progression to other treatments

    Time frame: Within 6 months after completion

    Progression to other medical or surgical treatments

Study contacts

Contact information is provided by the study sponsor or research team.

Solomon Hayon, MD

CONTACT

[email protected]

18437927888

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jun 24, 2025
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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