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Transcranial Magnetic Stimulation for Chronic Scrotal Content Pain

ConditionScrotal Pain
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorMedical University of South Carolina

About this trial

The purpose of this study is to perform an open label feasibility trial of TMS for the treatment of chronic scrotal content pain.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male patients with chronic scrotal pain lasting for 6 or more months.

Pain must be present 3 or more days of the week.

Disqualifiers

No new pain medications within the last 30 days.

Trial design

Design model

Single group

Treatments tested in this trial

  • Transcranial magnetic stimulation

    Other intervention

    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).

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Open labelExperimental treatment 1 intervention

Trial outcomes

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

Time frame
baseline, and post intervention (0 days, 1 week, 2 weeks, 1 month, 3 months, 6 months)

Secondary outcomes

1

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

Time frame
baseline, and post intervention (0 days, 1 week, 2 weeks, 1 month, 3 months, 6 months)
2

Progression to other treatments

Progression to other medical or surgical treatments

Time frame
Within 6 months after completion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of South Carolina

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: