Scrotal PainPhase 1/2NCT07035119
Transcranial Magnetic Stimulation for Chronic Scrotal Content Pain
A Phase 1/2 study testing Transcranial magnetic stimulation in people with Scrotal Pain, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this study is to perform an open label feasibility trial of TMS for the treatment of chronic scrotal content pain. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Scrotal Pain
- What is being tested?
- Transcranial magnetic stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2026to 23 Sep 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients with chronic scrotal pain lasting for 6 or more months.
- Pain must be present 3 or more days of the week.
Who cannot join
- No new pain medications within the last 30 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
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.
Read the 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.
- Conditions
- Scrotal Pain
- Being tested
- Transcranial magnetic stimulation
- Keywords
- Scrotal pain, testicular pain, Transcranial magnetic stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial magnetic stimulationOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
A custom developed SMS text EMA system will be used to gather daily data on pain
Measured: baseline, and post intervention (0 days, 1 week, 2 weeks, 1 month, 3 months, 6 months)
Progression to other treatments
Progression to other medical or surgical treatments
Measured: Within 6 months after completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start23 Sep 2026
- Primary completion23 Sep 2026
- Study completion23 Sep 2026
Why it stopped: Study discontinued before starting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Scrotal PainStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffery Brockardt, Ph.D., Study director, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07035119
- Sponsor's protocol ID
- Pro00140222
- Status last verified
- Oct 2026
- First submitted
- 7 Apr 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Based on internal IRB submission, IPD will not be shared
Publications
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.
PubMed 24729198Hamid 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.
PubMed 31824787Parekattil 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.
PubMed 32754451Young 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.
PubMed 25240669Ziegelmann 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.
PubMed 31768134
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Magnetic Stimulation for Chronic Scrotal Content Pain
- ClinicalTrials.gov ID
- NCT07035119
- Acronym / sponsor ID
- Pro00140222
- Conditions
- Scrotal Pain
- Keywords
- Scrotal pain, testicular pain, Transcranial magnetic stimulation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study discontinued before starting
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 23 Sep 2026 (actual)
- Primary completion
- 23 Sep 2026 (actual)
- Study completion
- 23 Sep 2026 (actual)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open label | Experimental | Other: Transcranial magnetic stimulationOpen label study. Participants will be screened by study staff for contraindications to TMS treatment. TMS will be delivered use the MagVenture TMS machine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male patients with chronic scrotal pain lasting for 6 or more months.
- Pain must be present 3 or more days of the week.
Key exclusion criteria (1 listed)
- No new pain medications within the last 30 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial magnetic stimulationResting 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). | Other | Open label |
Primary outcome
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
2 secondary outcomes
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)
Progression to other treatments
Time frame: Within 6 months after completion
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Background: PubMed 24729198O'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.
- Background: PubMed 31824787Hamid 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.
- Background: PubMed 32754451Parekattil 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.
- Background: PubMed 25240669Young 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.
- Background: PubMed 31768134Ziegelmann 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.
- Individual participant dataSharing planned: No. Based on internal IRB submission, IPD will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffery Brockardt, Ph.D. study director
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Transcranial magnetic stimulation in people with Scrotal Pain, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07035119, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.