Effect of Repetitive Transcranial Direct Current Stimulation (tDCS) on Chronic Pelvic Pain - Full Text View

Sponsored by:	Summa Health System
Information provided by:	Summa Health System
ClinicalTrials.gov Identifier:	NCT00554320

Purpose

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.

Condition	Intervention
Chronic Pelvic Pain Interstitial Cystitis Post Traumatic Stress Disorder Fibromyalgia Irritable Bowel Syndrome	Procedure: tDCS

MedlinePlus related topics: Fibromyalgia Interstitial Cystitis Pelvic Pain Post-Traumatic Stress Disorder

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Effect of Repetitive Transcranial Direct Current Stimulation (tDCS) on Chronic Pelvic Pain

Further study details as provided by Summa Health System:

Primary Outcome Measures:

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 Measures:

Interstitial cystitis symptom index: [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	June 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator 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, 2 mA of transcranial direct current stimulation will be applied for 20 minutes.	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 20 minutes.
C: Placebo Comparator For sham-controlled tDCS subjects, the same montage will be used; however current will be applied only for 30 seconds.	Procedure: tDCS For sham-controlled tDCS subjects, the same montage will be used; however current will be applied only for 30 seconds.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00554320

Locations

United States, Ohio
Summa Health System	Recruiting
Akron, Ohio, United States, 44309
Contact: Bradford W Fenton, MD, PhD 330-375-4810 fentonb@summa-health.org
Principal Investigator: Bradrord W Fenton, MD, PhD

Sponsors and Collaborators

Summa Health System

Investigators

Principal Investigator:

Bradford W Fenton, MD, PhD

Summa Health System

More Information

Responsible Party:	Summa Helath System ( Bradford W. Fenton, MD, PhD; Director )
Study ID Numbers:	RP07066
Study First Received:	November 2, 2007
Last Updated:	July 11, 2008
ClinicalTrials.gov Identifier:	NCT00554320
Health Authority:	United States: Institutional Review Board

Keywords provided by Summa Health System:

vulvodynia
painful bladder syndrome
myofascial pain syndrome
pelvic floor tension myalgia

Study placed in the following topic categories:

Gastrointestinal Diseases
Colonic Diseases
Pain
Stress Disorders, Traumatic
Signs and Symptoms
Urologic Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Mental Disorders
Irritable Bowel Syndrome
Stress Disorders, Post-Traumatic
Cystocele
Myofascial Pain Syndromes

Fibromyalgia
Urinary Bladder Diseases
Stress
Cystitis
Rheumatic Diseases
Intestinal Diseases
Cystitis, Interstitial
Pelvic Pain
Muscular Diseases
Digestive System Diseases
Anxiety Disorders
Colonic Diseases, Functional

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome
Nervous System Diseases

ClinicalTrials.gov processed this record on January 15, 2009