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Effect of Repetitive Transcranial Direct Current Stimulation (tDCS) on Chronic Pelvic Pain

This study is currently recruiting participants.
Information provided by Summa Health System

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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.

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 ]
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
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:

  • 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.
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 
Principal Investigator:     Bradford W Fenton, MD, PhD     Summa Health System    
Information Provided By Summa Health System
Verification Date November 2007
First Received Date  November 2, 2007
Last Updated Date July 11, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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