Guided Imagery and Transcranial Direct Current Stimulation (tDCS) in Women With Chronic Pelvic Pain

Stopped early · Not applicable · Has a placebo group

Conditions studied: Cystitis, Interstitial, Pelvic Pain

In brief

This is a single blind, randomized controlled pilot trial of transcranial direct stimulation (tDCS) intervention or tDCS sham administered with a standardized guided imagery intervention. Up to 25 adult women with chronic pelvic pain will be enrolled and randomized (like a flip of the coin) to achieve a total sample size of 20 women. 10 women in one arm of the study will receive guided imagery with tDCS stimulation. 10 women in the other arm of the study will receive guided imagery with sham tDCS. Subjects will remain blinded until the end of the study.

Key facts

Study ID

NCT02781103

Run by

Kenneth M Peters, MD

People needed

1

Starts

2017-01-20

Expected to finish

2019-09-26

Last updated by the study team

2019-10-02

Who can join

Age: 18 and older, up to 64. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Beaumont Hospital-Royal Oak — Royal Oak, Michigan, United States

Full record on ClinicalTrials.gov

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