Transcranial Magnetic Stimulation for Chronic Scrotal Content Pain

NCT ID: NCT07035119

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-10

Study Completion Date

2030-04-01

Brief Summary

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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.

Detailed Description

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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. 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.

Conditions

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Scrotal Pain

Keywords

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Scrotal pain testicular pain Transcranial magnetic stimulation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Transcranial magnetic stimulation

Intervention Type 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).

Interventions

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Transcranial 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).

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffery Brockardt, Ph.D.

Role: STUDY_DIRECTOR

Medical University of South Carolina

Locations

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Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Countries

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United States

Central Contacts

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Solomon Hayon, MD

Role: CONTACT

Phone: 18437927888

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 24729198 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31824787 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32754451 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25240669 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31768134 (View on PubMed)

Other Identifiers

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Pro00140222

Identifier Type: -

Identifier Source: org_study_id