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

This study has been completed.
Sponsor:
Information provided by:
Summa Health System
ClinicalTrials.gov Identifier:
NCT00554320
First received: November 2, 2007
Last updated: September 17, 2009
Last verified: September 2009
  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 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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Repetitive Transcranial Direct Current Stimulation (tDCS) on Chronic Pelvic Pain

Resource links provided by NLM:


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: January 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
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.
Placebo Comparator: C
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Ohio
Summa Health System
Akron, Ohio, United States, 44309
Sponsors and Collaborators
Summa Health System
Investigators
Principal Investigator: Bradford W Fenton, MD, PhD Summa Health System
  More Information

No publications provided

Responsible Party: Bradford W. Fenton, MD, PhD; Director, Summa Helath System
ClinicalTrials.gov Identifier: NCT00554320     History of Changes
Other Study ID Numbers: RP07066
Study First Received: November 2, 2007
Last Updated: September 17, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Summa Health System:
vulvodynia
painful bladder syndrome
myofascial pain syndrome
pelvic floor tension myalgia

Additional relevant MeSH terms:
Cystitis, Interstitial
Fibromyalgia
Irritable Bowel Syndrome
Myofascial Pain Syndromes
Pelvic Pain
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Syndrome
Anxiety Disorders
Colonic Diseases
Colonic Diseases, Functional
Cystitis
Digestive System Diseases
Disease
Gastrointestinal Diseases
Intestinal Diseases
Mental Disorders
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Pain
Pathologic Processes
Rheumatic Diseases
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on November 20, 2014