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

Primary Purpose

Chronic Pelvic Pain, Interstitial Cystitis, Post Traumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
tDCS
tDCS
Sponsored by
Summa Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pelvic Pain focused on measuring vulvodynia, painful bladder syndrome, myofascial pain syndrome, pelvic floor tension myalgia

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Summa Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

A

C

Arm Description

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.

Outcomes

Primary Outcome Measures

Patient Global Assessment (PGA):
Visual analog scale (VAS) for pain:

Secondary Outcome Measures

Interstitial cystitis symptom index:

Full Information

First Posted
November 2, 2007
Last Updated
September 17, 2009
Sponsor
Summa Health System
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1. Study Identification

Unique Protocol Identification Number
NCT00554320
Brief Title
Effect of Repetitive Transcranial Direct Current Stimulation (tDCS) on Chronic Pelvic Pain
Official Title
Effect of Repetitive Transcranial Direct Current Stimulation (tDCS) on Chronic Pelvic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Summa Health System

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pelvic Pain, Interstitial Cystitis, Post Traumatic Stress Disorder, Fibromyalgia, Irritable Bowel Syndrome
Keywords
vulvodynia, painful bladder syndrome, myofascial pain syndrome, pelvic floor tension myalgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
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.
Arm Title
C
Arm Type
Placebo Comparator
Arm Description
For sham-controlled tDCS subjects, the same montage will be used; however current will be applied only for 30 seconds.
Intervention Type
Procedure
Intervention Name(s)
tDCS
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
tDCS
Intervention Description
For sham-controlled tDCS subjects, the same montage will be used; however current will be applied only for 30 seconds.
Primary Outcome Measure Information:
Title
Patient Global Assessment (PGA):
Time Frame
2 weeks
Title
Visual analog scale (VAS) for pain:
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Interstitial cystitis symptom index:
Time Frame
2 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bradford W Fenton, MD, PhD
Organizational Affiliation
Summa Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Summa Health System
City
Akron
State/Province
Ohio
ZIP/Postal Code
44309
Country
United States

12. IPD Sharing Statement

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

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