- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00554320
Effect of Repetitive Transcranial Direct Current Stimulation (tDCS) on Chronic Pelvic Pain
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Akron, Ohio, United States, 44309
- Summa Health System
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
For sham-controlled tDCS subjects, the same montage will be used; however current will be applied only for 30 seconds.
|
Placebo Comparator: C
For sham-controlled tDCS subjects, the same montage will be used; however current will be applied only for 30 seconds.
|
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.
For sham-controlled tDCS subjects, the same montage will be used; however current will be applied only for 30 seconds.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patient Global Assessment (PGA):
Time Frame: 2 weeks
|
2 weeks
|
Visual analog scale (VAS) for pain:
Time Frame: 2 weeks
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Interstitial cystitis symptom index:
Time Frame: 2 weeks
|
2 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bradford W Fenton, MD, PhD, Summa Health System
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Digestive System Diseases
- Pathologic Processes
- Nervous System Diseases
- Urologic Diseases
- Urinary Bladder Diseases
- Pain
- Neurologic Manifestations
- Disease
- Gastrointestinal Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Colonic Diseases, Functional
- Colonic Diseases
- Intestinal Diseases
- Trauma and Stressor Related Disorders
- Syndrome
- Cystitis
- Irritable Bowel Syndrome
- Stress Disorders, Traumatic
- Stress Disorders, Post-Traumatic
- Fibromyalgia
- Cystitis, Interstitial
- Pelvic Pain
Other Study ID Numbers
- RP07066
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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