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

NCT ID: NCT00554320

Last Updated: 2009-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2009-06-30

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

A

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.

Group Type: ACTIVE_COMPARATOR

tDCS

Intervention Type: 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.

C

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

Group Type: PLACEBO_COMPARATOR

tDCS

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: PROCEDURE

tDCS

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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Summa Health System

OTHER

Sponsor Role: lead

Responsible Party

Summa Helath System

Principal Investigators

Bradford W Fenton, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Summa Health System

Locations

Summa Health System

Akron, Ohio, United States

Countries

United States

Other Identifiers

RP07066

Identifier Type: -

Identifier Source: org_study_id