An interventional study of tDCS and tDCS in Chronic Pelvic Pain, Interstitial Cystitis and Post Traumatic Stress Disorder, sponsored by Summa Health System. Completed at 1 site in United States. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2009-09-18.
Sponsored by Summa Health System · Not applicable, Interventional, and Treatment
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.
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This study's planned enrollment of 24 is below the median of 60 across 1,035 interventional studies indexed under Fibromyalgia.
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Exclusion Criteria:
During each session, the anode electrode will be placed on the motor cortex (contralateral to the most \[or predominant\] painful side \[or the side where the symptoms begin or the left as a default\]) and the cathode will be placed over the contralateral supraorbital area. In active tDCS subjects, 1 mA of transcranial direct current stimulation will be applied for 30 minutes.
Procedure: tDCS
For sham-controlled tDCS subjects, the same montage will be used; however current will be applied only for 30 seconds.
Procedure: tDCS
During each session, the anode electrode will be placed on the motor cortex (contralateral to the most \[or predominant\] painful side \[or the side where the symptoms begin or the left as a default\]) and the cathode will be placed over the contralateral supraorbital area. In active tDCS subjects, 1 mA of transcranial direct current stimulation will be applied for 30 minutes.
For sham-controlled tDCS subjects, the same montage will be used; however current will be applied only for 30 seconds.
Patient Global Assessment (PGA):
Time frame: 2 weeks
Visual analog scale (VAS) for pain:
Time frame: 2 weeks
Interstitial cystitis symptom index:
Time frame: 2 weeks
This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.
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Summa Health System