Status:
COMPLETED
Transcranial Direct Stimulation in Chronic Pelvic Pain
Lead Sponsor:
Spaulding Rehabilitation Hospital
Conditions:
Pelvic Pain
Healthy
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
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 de...
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 involv...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
- Have had no neurosurgery as self reported
- No history of psychological disorders as self reported
- Must have the ability to feel pain as self reported
Exclusion
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01143636
Start Date
April 1 2010
End Date
May 1 2013
Last Update
April 24 2020
Active Locations (1)
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1
Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States, 02114