|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | November 2, 2007 | ||||
| Last Updated Date | September 17, 2009 | ||||
| Start Date ICMJE | January 2009 | ||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
|
||||
| Original Primary Outcome Measures ICMJE |
|
||||
| Change History | Complete list of historical versions of study NCT00554320 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Interstitial cystitis symptom index: [ Time Frame: 2 weeks ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Interstitial cystitis symptom index: [ Time Frame: 2 weeks ] | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Repetitive Transcranial Direct Current Stimulation (tDCS) on Chronic Pelvic Pain | ||||
| Official Title ICMJE | 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 one year 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 5 days of tDCS treatment is safe for use in chronic pelvic pain patients. Safety will be assessed through neuropsychological tests and adverse event reporting. |
||||
| Detailed Description | |||||
| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study | ||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | Procedure: tDCS | ||||
| Study Arms / Comparison Groups |
|
||||
| Publications * | |||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 24 | ||||
| Completion Date | June 2009 | ||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Female | ||||
| Ages | 18 Years to 55 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00554320 | ||||
| Responsible Party | Bradford W. Fenton, MD, PhD; Director, Summa Helath System | ||||
| Study ID Numbers ICMJE | RP07066 | ||||
| Study Sponsor ICMJE | Summa Health System | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
|
||||
| Information Provided By | Summa Health System | ||||
| Verification Date | September 2009 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||