Effect of Repetitive Transcranial Direct Current Stimulation (tDCS) on Chronic Pelvic Pain
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 ]
- 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 |
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 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 Fibromyalgia Myofascial Pain Syndromes Irritable Bowel Syndrome Pelvic Pain Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Cystitis, Interstitial Urinary Bladder Diseases Urologic Diseases Muscular Diseases Musculoskeletal Diseases |
Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases Colonic Diseases, Functional Colonic Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Pain Signs and Symptoms Anxiety Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 22, 2013