Study of the Acute Effects of Guided Imagery and tDCS on Pain Levels in Women With Chronic Pelvic Pain

Withdrawn before enrolling · Not applicable · Has a placebo group

Conditions studied: Pelvic Pain, Chronic Pain

In brief

This is a single blind, randomized, exploratory study of transcranial direct stimulation (tDCS) intervention or sham tDCS administered with a standardized guided imagery intervention for chronic pelvic pain. Transcranial Direct Current Sstimulation (tDCS) is a non-invasive brain stimulation therapy. Guided Imagery is a form of hypnosis used to create relaxation.Up to 25 adult women with chronic pelvic pain will be enrolled and randomized (like a flip of a coin). Subjects will remain blinded throughout the study. Subjects will be randomized into one of the following four arms: active tDCS with guided imagery, active tDCS alone (without guided imagery), sham tDCS with guided imagery, or sham tDCS alone (without guided imagery).

Key facts

Study ID

NCT04250662

Run by

Corewell Health East

People needed

0

Starts

2020-02-01

Expected to finish

2022-11-17

Last updated by the study team

2022-11-23

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 (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 not related to menstrual cycle and of at lease 6 months duration and refractory to other treatments.
• Subject agrees to not start any new treatments (medication or otherwise) throughout the study participation.
• Subject agrees to maintain stable doses of all current medications throughout study participation.

You may not qualify if…

• History of seizures during the last 2 years or diagnosis of epilepsy
• Pacemaker
• Use of carbamazepine, oxcarbazepine, phenytoin, pramipexole or cabergoline within the past 6 months as self-reported
• Parkinson's Disease
• Any condition, including neurological or psychiatric illness, which per investigators' judgment, may increase subject risk
• History of Hunner's lesions
• Lactation, pregnancy, or refusal to use medically approved/reliable birth control in women of child-bearing potential
• Sacral or 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
• Deferral Criteria
• If a subject has a confirmed UTI, she will be deferred until treatment is completed and symptoms resolve
• Participating in another intervention study, or received an investigational drug or device within 4 weeks prior to screening
• Subject received bladder hydrodistention within the past 12 weeks
• Within the past 4 weeks, initiation of any new medications or any intravesical treatment for treatment of IC/BPS
• Within the past 24 weeks received any surgery or procedure which may impact the pelvic floor
• 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 Health System — Royal Oak, Michigan, United States
• Beaumont Hospital-Royal Oak — Royal Oak, Michigan, United States

Full record on ClinicalTrials.gov

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