Transcranial Direct Stimulation in Chronic Pelvic Pain

Mass General Brigham

Status and phase: Completed; Phase 2

Conditions: Healthy; Pelvic Pain

Treatments: Device: Transcranial Direct Current Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT01143636

2009-P-002048

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 35 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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35 participants in 4 patient groups

Active tDCS - pelvic pain patients

Sham Comparator group

Description:

ACTIVE tDCS: Subjects will receive a total of 10 consecutive sessions of active tDCS over a two-week period (administered Monday - Friday). During each session, the anode electrode will be placed over the primary motor cortex of the predominantly painful side.

Treatment:

Device: Transcranial Direct Current Stimulation

Sham tDCS - pelvic pain patients

Experimental group

Description:

SHAM tDCS: Subjects will receive a total of 10 consecutive sessions of sham tDCS over a two-week period (administered Mon-Fri). During each session, the anode will be placed over the primary motor cortex of the predominantly painful side.

Treatment:

Device: Transcranial Direct Current Stimulation

Active tDCS - healthy

Experimental group

Description:

The healthy controls will undergo one day of treatment with active tDCS. All participants will receive both active and sham stimulation in a randomized order.

Treatment:

Device: Transcranial Direct Current Stimulation

Sham tDCS - healthy

Experimental group

Description:

The healthy controls will undergo one day of treatment with sham tDCS. All participants will receive both active and sham stimulation in a randomized order.

Treatment:

Device: Transcranial Direct Current Stimulation