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

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00554320
• Other study ID #: RP07066
• Status: Completed
• Phase: N/A
• First received: November 2, 2007
• Last updated: September 17, 2009
• Start date: January 2009
• Est. completion date: June 2009

Study information

• Verified date: September 2009
• Source: Summa Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	Summa Health System	Akron	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Summa Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Global Assessment (PGA):		2 weeks	No
Primary	Visual analog scale (VAS) for pain:		2 weeks	No
Secondary	Interstitial cystitis symptom index:		2 weeks	No