Transcranial Direct Stimulation in Chronic Pelvic Pain



Status:Completed
Conditions:Healthy Studies, Women's Studies
Therapuetic Areas:Other, Reproductive
Healthy:No
Age Range:18 - 64
Updated:3/16/2017
Start Date:April 2010
End Date:May 2013

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Investigation and Treatment of Central Nervous System Dysfunction in Chronic Pelvic Pain.

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.

The study encompasses two experiments: The first one involves patients with chronic pain,
receiving 10 sessions of stimulation, active or sham (parallel design).

The second experiment involves involves healthy subjects, receiving active or sham tDCS over
the primary motor cortex (crossover design).

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
We found this trial at
1
site
300 1st Avenue
Boston, Massachusetts 02129
617-952-5000
Spaulding Rehabilitation Hospital At Spaulding Rehabiliation Hospital Boston, our unique approach to therapy includes use...
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mi
from
Boston, MA
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