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Effect of Repetitive Transcranial Direct Current Stimulation (tDCS) on Chronic Pelvic Pain
This study has been completed.
Study NCT00554320   Information provided by Summa Health System
First Received: November 2, 2007   Last Updated: September 17, 2009   History of Changes

November 2, 2007
September 17, 2009
January 2009
June 2009   (final data collection date for 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 ]
  • Patient Global Assessment (PGA): [ Time Frame: 2 weeks ]
  • Visual analog scale (VAS) for pain: [ Time Frame: 2 weeks ]
Complete list of historical versions of study NCT00554320 on ClinicalTrials.gov Archive Site
Interstitial cystitis symptom index: [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Interstitial cystitis symptom index: [ Time Frame: 2 weeks ]
 
Effect of Repetitive Transcranial Direct Current Stimulation (tDCS) on Chronic Pelvic Pain
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 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.

 
 
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
  • Chronic Pelvic Pain
  • Interstitial Cystitis
  • Post Traumatic Stress Disorder
  • Fibromyalgia
  • Irritable Bowel Syndrome
Procedure: tDCS
  • Active Comparator: 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.
  • Placebo Comparator: For sham-controlled tDCS subjects, the same montage will be used; however current will be applied only for 30 seconds.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
24
June 2009
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects must be females between 18 and 55 years of age.
  • Subjects must have a current VAS for pelvic pain of 5 or more.

Exclusion Criteria:

  • Known pelvic malignancy.
  • Patients with major depression with suicidal risk as clinically defined.
  • Patients with other known, uncontrolled neuropsychiatric disorders.
  • Abnormal neurological examination other than as signs of the condition studied in the present protocol.
  • Contraindication to tDCS:
  • A history of unmanaged substance abuse or dependence within the last 6 months.
  • A history of previous treatment with tDCS.
Female
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00554320
Bradford W. Fenton, MD, PhD; Director, Summa Helath System
RP07066
Summa Health System
 
Principal Investigator: Bradford W Fenton, MD, PhD Summa Health System
Summa Health System
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP