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| Descriptive Information Fields | |||||
| Brief Title † | Effect of Repetitive Transcranial Direct Current Stimulation (tDCS) on Chronic Pelvic Pain | ||||
| Official Title † | Effect of Repetitive Transcranial Direct Current Stimulation (tDCS) on Chronic Pelvic Pain | ||||
| Brief Summary | We will rigorously test whether modulation of the motor cortex by transcranial direct current stimulation (tDCS) is an effective treatment for patients with chronic pelvic pain through the following specific aims: A) The primary aim of this study is to determine whether transcranial direct current stimulation applied to the motor cortex in patients with chronic pelvic pain induces a significant decrease in the pain or symptoms as compared with sham tDCS. We will also measure changes in the clinical symptom scores of multiple pelvic organs, drug intake (narcotic), anxiety, depression, traumatic stress, as well as overall improvement in the quality of life to assess the effects of this treatment. B) Determine the duration of the clinical effects of tDCS. We will therefore compare the amelioration of pain and related symptoms between active and sham tDCS for two weeks following treatment. C) Determine whether tDCS changes the threshold for pain detection as compared with sham tDCS. Patients with chronic pelvic pain have a lower threshold for pain as compared to healthy subjects and we hypothesized that this threshold will increase after stimulation with tDCS. D) Finally, we will examine whether 2 days of tDCS treatment is safe for use in chronic pelvic pain patients. Safety will be assessed through neuropsychological tests and adverse event reporting. |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | Patient Global Assessment (PGA): [ Time Frame: 2 weeks ] [ Designated as safety issue: No ] Visual analog scale (VAS) for pain: [ Time Frame: 2 weeks ] [ Designated as safety issue: No ] |
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| Secondary Outcome Measure † | Interstitial cystitis symptom index: [ Time Frame: 2 weeks ] [ Designated as safety issue: No ] | ||||
| Condition † | Chronic Pelvic Pain Interstitial Cystitis Post Traumatic Stress Disorder Fibromyalgia Irritable Bowel Syndrome |
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| Intervention † | Procedure: tDCS | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 24 | ||||
| Start Date † | June 2007 | ||||
| Completion Date | December 2009 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 55 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00554320 | ||||
| Organization ID | RP07066 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Summa Health System | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | Summa Health System | ||||
| Verification Date | November 2007 | ||||
| First Received Date † | November 2, 2007 | ||||
| Last Updated Date | June 23, 2008 | ||||