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Completed

NCT Number: NCT00554320

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.

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Key information

Conditions

Chronic Pelvic Pain Colonic Diseases Colonic Diseases, Functional Cystitis Cystitis, Interstitial Digestive System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fibromyalgia Gastrointestinal Diseases Genital Diseases Genital Diseases, Female Interstitial Cystitis Intestinal Diseases Irritable Bowel Syndrome Male Urogenital Diseases Mental Disorders Muscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes Nervous System Diseases Neuromuscular Diseases Post Traumatic Stress Disorder Rheumatic Diseases Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Urinary Bladder Diseases Urogenital Diseases Urologic Diseases Vulvar Diseases Vulvodynia

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Summa Health System

Akron, Ohio, 44309, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

tDCS

Procedure

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.

Primary outcomes

  1. Patient Global Assessment (PGA):

    Time frame: 2 weeks

  2. Visual analog scale (VAS) for pain:

    Time frame: 2 weeks

Secondary outcomes

  1. Interstitial cystitis symptom index:

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Summa Health System

Other

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Nov 6, 2007
Registry last updated
Sep 18, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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