Transcranial Direct Stimulation in Chronic Pelvic Pain

Completed · Phase 2 · Has a placebo group

Conditions studied: Pelvic Pain, Healthy

In brief

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.

Key facts

Study ID

NCT01143636

Run by

Spaulding Rehabilitation Hospital

People needed

35

Starts

2010-04-01

Expected to finish

2013-05-01

Last updated by the study team

2020-04-24

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Providing informed consent to participate in the study
• 18 to 64 years old
• 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)
• No history of or current genitourinary tuberculosis as self reported
• No history of urethral cancer as self reported
• No history or current bladder malignancy, high grade dysplasia or carcinoma in situ as self reported
• No occurrence of ovarian, vaginal or cervical cancer in the previous 3 years as self reported
• No current vaginal infection as self reported
• No active herpes in previous 3 months as self reported
• No antimicrobials for urinary tract infections in previous 3 months as self reported
• Never treated with cyclophosphamide as self reported
• No radiation cystitis as self reported
• No neurogenic bladder dysfunction (due to a spinal cord injury, stroke, Parkinson's disease, multiple sclerosis, spina bifida or diabetic cystopathy) as self reported
• Absence of bladder, ureteral or urethral calculi for previous 3 months as self reported
• No urethritis for previous 3 months as self reported
• No urethral dilatation, cystometrogram, bladder cystoscopy with full anesthesia or bladder biopsy in previous 3 months as self reported
• Must not be pregnant
• Eligible to MRI according to MRI screening checklist
• No contraindications to tDCS:
• No history of alcohol or drug abuse within the past 6 months as self reported
• No use of carbamazepine as self reported
• Does not have severe depression (with a score of >30 in the Beck Depression Inventory)
• No history of neurological disorders as self reported
• No history of unexplained fainting spells as self reported,
• No history of head injury resulting in more than a momentary loss of consciousness as self reported

Where it is running

• Spaulding Rehabilitation Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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