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

NCT00554320 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2009-09-18

No results posted yet for this 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

  • Chronic Pelvic Pain
  • Interstitial Cystitis
  • Post Traumatic Stress Disorder
  • Fibromyalgia
  • Irritable Bowel Syndrome

Interventions

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.

PROCEDURE

tDCS

For sham-controlled tDCS subjects, the same montage will be used; however current will be applied only for 30 seconds.

Sponsors & Collaborators

  • Summa Health System

    lead OTHER

Principal Investigators

  • Bradford W Fenton, MD, PhD · Summa Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00554320 on ClinicalTrials.gov