Menu
Not yet recruiting NCT07035119

Transcranial Magnetic Stimulation for Chronic Scrotal Content Pain

Phase I / Phase II Interventional Scrotal Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcranial magnetic stimulation.
Who it may be relevant to
Registry conditions: Scrotal Pain. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other 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 t

Primary outcome measures

  • 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)]
Secondary outcome measures (2)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Medical University of South Carolina — Charleston

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. PMID 24729198
  • 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. PMID 31824787
  • 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. PMID 32754451
  • 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. PMID 25240669
  • 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. PMID 31768134

Identifiers

NCT: NCT07035119 · Pro00140222

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗