Guided Imagery and Transcranial Direct Current Stimulation (tDCS) in Women With Chronic Pelvic Pain
Cystitis, Interstitial, Pelvic Pain
About this trial
This is an interventional treatment trial for Cystitis, Interstitial
Eligibility Criteria
Inclusion Criteria:
- Female
- Age 18 to 64 years
- Women must either be unable to become pregnant (are surgically sterile or postmenopausal) or must use an approved method of birth control throughout the study period.
- Self- reported CPP defined as pelvic pain that is non-cyclical and of at least 6 months duration and refractory to other treatments
- Subject agrees to not start any new treatment (medication or otherwise) throughout the study treatment and follow up periods.
- Subject agrees to maintain stable doses of all current medications throughout the study treatment and follow-up period.
Exclusion Criteria:
- Pacemaker
- History of seizures during the last 2 years or diagnosis of epilepsy
- Currently using tobacco
- Parkinson's Disease
- Any condition, including neurological or psychiatric illness, which per investigators' judgement may increase subject risk
- History of Hunner's lesion in the medical record
- Lactation, pregnancy, or refusal to use medically approved/reliable birth control in women of child-bearing potential
- Sacral, pudendal Interstim® or spinal cord stimulator that is "on".
- Contraindications to tDCS stimulation (e.g. metal in the head, implanted brain medical devices, scalp wounds or infections, etc.)
- History of head injury resulting in more than a momentary loss of consciousness during the last 2 years
Note: For the sake of preserving scientific integrity, one or more of the eligibility criteria have been left off the list posted while the trial is ongoing. A full list of eligibility criteria will be posted upon completion of the trial.
Sites / Locations
- Beaumont Hospital-Royal Oak
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Guided imagery plus active tDCS
Guided imagery plus Sham tDCS
Subjects will receive 2 milliamps of electrical stimulation to the brain (transcranial direct stimulation-tDCS) for 20 minutes concurrently while listening to a guided imagery CD specifically designed for women with chronic pelvic pain.
Subjects will receive 2 milliamps of electrical stimulation to the brain (transcranial direct stimulation-tDCS) for only 30 seconds and then the device will be turned off. The device will remain in place, however, for 20 minutes while the subject listens to a guided imagery CD specifically designed for women with chronic pelvic pain.