Clinical trial NCT00554320: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Summa Health System
Sponsor class: OTHER
First posted: 2007-11-06
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Patient Global Assessment (PGA):
timeFrame: 2 weeks
measure: Visual analog scale (VAS) for pain:
timeFrame: 2 weeks
Secondary outcomes:
measure: Interstitial cystitis symptom index:
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Akron
country: United States
facility: Summa Health System
state: Ohio
Study officials:
affiliation: Summa Health System
name: Bradford W Fenton, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: