Transcranial Direct Stimulation in Chronic Pelvic Pain
Condition: Pelvic Pain; Healthy
MeSH terms: Pelvic Pain
Intervention: Transcranial Direct Current Stimulation
Intervention description: Chronic pain subjects will be randomized to receive either active or sham stimulation for the duration of the trial. The subject will receive 10 consecutive sessions at an intensity of 2mA with each session lasting 20 minutes. If the subject receives active stimulation the current will be applied for the full 20 minutes, while in the sham group current will only be applied for 30 seconds. In the healthy cohort, subjects will receive one session of active stimulation and one session of sham stimulation. The parameters will be the same as the pain subjects, at an intensity of 2mA for 20 minutes.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: For the experiment in patients with pelvic pain, the design is parallel. For the experiment in healthy subjects, the design is crossover.
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Transcranial direct current stimulation; Chronic Pelvic Pain

Summary:

      The purpose of this study is to determine whether transcranial direct current stimulation
      (tDCS) is effective in reducing pain in subjects with chronic pelvic pain. Our hypothesis is
      that tDCS will decrease pain significantly when compared to sham stimulation.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Providing informed consent to participate in the study

          2. 18 to 64 years old

          3. Having symptoms of pelvic pain for more than 6 months with an average of 3 on a 0-10
             VAS scale (for pelvic pain subjects only)

          4. No history of or current genitourinary tuberculosis as self reported

          5. No history of urethral cancer as self reported

          6. No history or current bladder malignancy, high grade dysplasia or carcinoma in situ as
             self reported

          7. No occurrence of ovarian, vaginal or cervical cancer in the previous 3 years as self
             reported

          8. No current vaginal infection as self reported

          9. No active herpes in previous 3 months as self reported

         10. No antimicrobials for urinary tract infections in previous 3 months as self reported

         11. Never treated with cyclophosphamide as self reported

         12. No radiation cystitis as self reported

         13. No neurogenic bladder dysfunction (due to a spinal cord injury, stroke, Parkinson's
             disease, multiple sclerosis, spina bifida or diabetic cystopathy) as self reported

         14. Absence of bladder, ureteral or urethral calculi for previous 3 months as self
             reported

         15. No urethritis for previous 3 months as self reported

         16. No urethral dilatation, cystometrogram, bladder cystoscopy with full anesthesia or
             bladder biopsy in previous 3 months as self reported

         17. Must not be pregnant

         18. Eligible to MRI according to MRI screening checklist

         19. No contraindications to tDCS:

         20. No history of alcohol or drug abuse within the past 6 months as self reported

         21. No use of carbamazepine as self reported

         22. Does not have severe depression (with a score of >30 in the Beck Depression Inventory)

         23. No history of neurological disorders as self reported

         24. No history of unexplained fainting spells as self reported,

         25. No history of head injury resulting in more than a momentary loss of consciousness as
             self reported

         26. Have had no neurosurgery as self reported

         27. No history of psychological disorders as self reported

         28. Must have the ability to feel pain as self reported