Clinical trial NCT01143636: Transcranial Direct Stimulation in Chronic Pelvic Pain
Official title: Investigation and Treatment of Central Nervous System Dysfunction in Chronic Pelvic Pain.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pelvic Pain
Healthy
Keywords: Transcranial direct current stimulation
Chronic Pelvic Pain
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2010-06-14
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

Brief 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.

Detailed 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).

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

Primary outcomes:
measure: Pain Assessment
timeFrame: baseline and at 2 weeks
measure: Pressure Pain Threshold
timeFrame: baseline and at 2 weeks
Secondary outcomes:
measure: Quality of Life Scale (QOLS)
timeFrame: 2 weeks
measure: Clinical Global Impression - CGI
timeFrame: 2 weeks
measure: Visual Analogue Scale - Anxiety.This Scale Measures Patients' Level of Anxiety on a Scale (0-no Anxiety to 10-worst Anxiety Ever). It Was Performed at the End of the Treatment and Compared Between the 2 Groups (Real and Sham) in Patients With Pelvic Pain
timeFrame: 2 weeks
measure: Mini Mental Scale - MMS
timeFrame: 2 weeks
measure: Beck Depression Inventory - BDI.
timeFrame: 2 weeks
measure: Patient Global Assessment - PGA
timeFrame: 2 weeks
measure: Von Frey
timeFrame: baseline and at 2 weeks
measure: Pain Pressure Threshold Test - PPT
timeFrame: baseline and at 2 weeks
measure: Diffuse Noxious Inhibitory Controls - DNIC.
timeFrame: baseline and at 2 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Spaulding Rehabilitation Hospital
state: Massachusetts
Study officials:
affiliation: Spaulding Rehabilitation Hospital
name: Felipe Fregni, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: