Overview

This trial is active, not recruiting.

Condition pelvic pain
Treatment transcranial direct current stimulation
Phase phase 2
Sponsor Spaulding Rehabilitation Hospital
Start date April 2010
End date December 2012
Trial size 68 participants
Trial identifier NCT01143636, 2009-P-002048

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.

In addition, the investigators aim to determine the safety of this intervention via a battery of neurocognitive tests. The investigators hypothesize that tDCS induces no cognitive worsening as compared with sham tDCS.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose treatment
Arm
(Sham Comparator)
SHAM tDCS: For sham-controlled tDCS subjects, the same montage will be used; however current will be applied only for 30 seconds.
transcranial direct current stimulation tDCS, electrical stimulation
Stimulation will be given at 2 mA for a period of 20 minutes.
(Experimental)
ACTIVE tDCS: Subjects will receive a total of 20 consecutive sessions of either active tDCS or sham tDCS over a four-week period (administered every day Monday- Friday). During each session, the anode electrode will be placed on the primary motor cortex of the predominant painful side.
transcranial direct current stimulation tDCS, electrical stimulation
Stimulation will be given at 2 mA for a period of 20 minutes.
(Experimental)
The healthy controls will receive one single session of active and one single session of sham tDCS. There will be a time interval of at least one week in between the randomized stimulation sessions to prevent a carryover affect.
transcranial direct current stimulation tDCS, electrical stimulation
Stimulation will be given at 2 mA for a period of 20 minutes.

Primary Outcomes

Measure
Sensory Test
time frame: 2 months

Secondary Outcomes

Measure
Evidence of an increase in overall quality of life and mental health
time frame: 2 months
Evidence of improvement in cognitive functioning
time frame: 2 months

Eligibility Criteria

Male or female participants from 18 years up to 64 years old.

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

Additional Information

Official title Investigation and Treatment of Central Nervous System Dysfunction in Chronic Pelvic Pain.
Principal investigator Felipe Fregni, MD, PhD
Description Subjects will receive 4 weeks of stimulation on consecutive days (Monday- Friday).
Trial information was received from ClinicalTrials.gov and was last updated in October 2012.
Information provided to ClinicalTrials.gov by Spaulding Rehabilitation Hospital.