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

WithdrawnNot applicableNCT04250662
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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).

Study details

Official title
A Randomized, Single Blind, Exploratory Study of the Acute Effects of Guided Imagery and Transcranial Direct Current Stimulation (tDCS) on Electroencephalogram (EEG) Alpha Brain Waves and Pain Levels in Women With Chronic Pelvic Pain
Interventions
  • Device: Active tDCS with guided imagery
  • Device: Active tDCS alone (no guided imagery)
  • Device: Sham tDCS with guided imagery
  • Device: Sham tDCS alone (no guided imagery)
Sponsor
Corewell Health East
Start date
2020-02
Primary completion
2022-11-17
Sex
Female
Age range
from 18 Years to 64 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
2

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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. Exclusion Criteria: * 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 1. If a subject has a confirmed UTI, she will be deferred until treatment is completed and symptoms resolve 2. Participating in another intervention study, or received an investigational drug or device within 4 weeks prior to screening 3. Subject received bladder hydrodistention within the past 12 weeks 4. Within the past 4 weeks, initiation of any new medications or any intravesical treatment for treatment of IC/BPS 5. 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.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04250662