Transcranial Magnetic Stimulation for Scrotal Pain

SH
Overseen BySolomon Hayon, MD
Age: 18+
Sex: Male
Trial Phase: Phase 1 & 2
Sponsor: Medical University of South Carolina
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Transcranial Magnetic Stimulation (TMS), a non-invasive treatment using magnetic fields, can reduce chronic scrotal pain. The aim is to determine if TMS is a feasible method for managing pain that persists for at least six months. Men experiencing scrotal pain at least three days a week may be suitable candidates for this study. Participants should not have started any new pain medications in the past 30 days. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative treatment.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but you cannot have started any new pain medications in the last 30 days.

What prior data suggests that Transcranial Magnetic Stimulation is safe for treating scrotal pain?

Research has shown that transcranial magnetic stimulation (TMS) is generally safe and easy to manage. Studies have found that side effects are usually mild and short-lived. Most people may experience temporary discomfort or pain on the scalp where the device contacts the skin. In one study, only a small number of participants (4.5%) discontinued treatment due to these side effects. This suggests that TMS is manageable for most individuals. Overall, TMS appears to be a low-risk option for treating conditions like chronic scrotal pain.12345

Why do researchers think this study treatment might be promising?

Transcranial Magnetic Stimulation (TMS) is unique because it offers a non-invasive approach to treating scrotal pain, unlike the standard options, which often involve medications or surgical interventions. TMS works by using magnetic fields to stimulate nerve cells in the brain, potentially altering pain perception and providing relief without the side effects associated with pain medications. Researchers are excited about TMS because it represents a novel mechanism of action and could offer a safer, more effective alternative for those suffering from chronic scrotal pain.

What evidence suggests that Transcranial Magnetic Stimulation is effective for scrotal pain?

Research has shown that Transcranial Magnetic Stimulation (TMS) can help reduce pain. One study found that 14 patients experienced less pain after 10 sessions of repetitive TMS. This technique uses magnetic fields to stimulate nerve cells in the brain, altering pain perception. Although TMS is often used for other types of chronic pain, its application for scrotal pain remains under investigation. In this trial, participants will receive TMS to assess its effectiveness for scrotal pain. Early results suggest it might be helpful, but further research is needed to confirm its efficacy for this specific type of pain.26789

Who Is on the Research Team?

JB

Jeffery Brockardt, Ph.D.

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for men who have had scrotal pain at least 3 days a week, ongoing for more than 6 months. Participants should not have started any new pain medications in the last 30 days.

Inclusion Criteria

I experience pain on most days of the week.
I am a male with chronic scrotal pain for 6+ months.

Exclusion Criteria

I haven't started any new pain medications in the last month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Treatment

TMS is delivered using the MagVenture TMS machine, 15 minutes per session, 3 sessions each day, for 3 days

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment using a custom developed SMS text EMA system

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Transcranial Magnetic Stimulation
Trial Overview The study is testing Transcranial Magnetic Stimulation (TMS), a non-invasive procedure that uses magnetic fields to stimulate nerve cells in the brain, as a potential treatment for chronic scrotal content pain.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Open labelExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials
994
Recruited
7,408,000+

Citations

Transcranial Magnetic Stimulation for Scrotal PainThe purpose of this study is to perform an open label feasibility trial of TMS for the treatment of chronic scrotal content pain. Who Is on the Research Team?
Part III Treatment of Chronic Scrotal Content PainThis Guideline covers the evaluation and treatment of men who present to a clinician with a complaint of chronic pelvic pain.
Genitofemoral Neuromodulation as a Novel Pain ...Our study suggests that GFM has the potential to significantly reduce pain and opioid use in patients with refractory chronic testicular pain.
ID: 328426 Repetitive Transcranial Magnetic Stimulation ...A repeat ilioinguinal/iliohypogastric nerve block was performed under ultrasound guidance and the patient reported greater than 50% pain relief. A temporary ...
Effect of Repetitive Transcranial Magnetic Stimulation on ...Results from this study revealed that pain reductions were improved in 14 patients who received 10 sessions of 20-Hz rTMS on the hand area of M1 ...
Dosage and safety of transcranial magnetic stimulation and ...The guidelines highlighted that, in studies that clearly report side effects, both real and sham stimulations have short-term and mild side ...
Safety and recommendations for TMS use in healthy subjects ...Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines
Male Chronic Pelvic Pain: AUA GuidelinePurpose: This Guideline covers the evaluation and treatment of men who present to a clinician with a complaint of chronic pelvic pain.
Efficacy and Safety of Transcranial Magnetic Stimulation in ...Active TMS was well tolerated with a low dropout rate for adverse events (4.5%) that were generally mild and limited to transient scalp discomfort or pain.
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