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NCT00554320 · ClinicalTrials.gov registry record · NA
Effect of Repetitive Transcranial Direct Current Stimulation (tDCS) on Chronic Pelvic Pain
A NA study of Post Traumatic Stress Disorder and Fibromyalgia, sponsored by Summa Health System.
- Completed
- Registry status
- NA
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT00554320 is a NA study of Post Traumatic Stress Disorder and Fibromyalgia that has completed, run by Summa Health System. The registered enrollment target is 24 participants, below the 1,117-participant average among 144 other Post Traumatic Stress Disorder trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00554320, a NA study of Post Traumatic Stress Disorder and Fibromyalgia, has completed, sponsored by Summa Health System.
- COMPLETED
- Registry status
- NA
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- PROCEDURE tDCS
Study Locations (1)
Ohio
- Summa Health System - Akron
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2009-01 |
| Est. Completion | 2009-06 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00554320
The ClinicalTrials.gov registry entry for NCT00554320 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,117-participant average among 144 other Post Traumatic Stress Disorder trials with a reported enrollment target (98% lower). The listed sponsor is Summa Health System, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 1 intervention - of which tDCS is the first listed.
NCT00554320 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT00554320 about?
NCT00554320 is a clinical study titled "Effect of Repetitive Transcranial Direct Current Stimulation (tDCS) on Chronic Pelvic Pain". 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 ...
What is the current status of trial NCT00554320?
This trial is currently completed. It is a NA study. The enrollment target is 24 participants. The study started on 2009-01. Estimated completion is 2009-06.
What conditions does trial NCT00554320 study?
This clinical trial studies the following conditions: Post Traumatic Stress Disorder, Fibromyalgia, Irritable Bowel Syndrome, Interstitial Cystitis, Chronic Pelvic Pain.
What interventions are being tested in trial NCT00554320?
The interventions under investigation include: tDCS (PROCEDURE).
Who is sponsoring clinical trial NCT00554320?
This trial is sponsored by Summa Health System, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00554320 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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