Clinical trial NCT04252040: Open Label Extension Study of tDCS Plus Guided Imagery for Women With Chronic Pelvic Pain (CPP)
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Pelvic Pain
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is an open label extension exploratory study. All eligible subjects will receive active tDCS with guided imagery.
Primary purpose: TREATMENT

Brief summary: This is an open label extension study trial of tDCS with a standardized guided imagery intervention. Up to 20 women with chronic pelvic pain, who completed participation in the initial randomized trial (IRB 2019-362) will be enrolled. Subjects will complete 5 tDCS treatments with guided imagery and a 1-week follow-up visit.

Detailed description: Chronic pelvic pain (CPP) is a common and often debilitating in women. It occurs below the umbilicus and is severe enough to cause functional impairment or require treatment. Transcranial Direct Stimulation (tDCS) is a non-invasive brain stimulation technique. As tDCS modulates nerve activity and connectivity, it is also expected to cause measurable changes in brain activity. Guided imagery is a form of hypnosis using words to direct one's thoughts and attention to imagined sensations. Guided imagery has demonstrated efficacy in reducing pain related to many conditions including cancer pain, chronic lower back pain, and post-operative pain. More information is needed to evaluate the effects of tDCS and guided imagery in the treatment of chronic pelvic pain.

This study consists of one screening visit, 5 study intervention visits, and a 1-week follow-up visit. After obtaining informed consent, study staff will assess for changes in medical history an pelvic pain treatments since the end of participation in Part 1 (IRB 2019-362). Urine will be collected for urinalysis and a urine pregnancy test will be collected for women of childbearing potential. If urinalysis and pregnancy test are negative, subjects will complete questionnaires, vitals, and a baseline EEG will be conducted.

At the 5 interventional visits, transcranial direct stimulation (tDCS) with guided imagery will be delivered. A EEG will be completed after the 1st and 5th treatment visits. At each visit questionnaires will be administered and urine pregnancy test, if the woman is of childbearing potential. At the 1-week follow- up visit, an EEG will be performed, questionnaires administered.

Eligibility criteria: Inclusion Criteria:

* Study participants must have participated and completed: (IRB 2019-362) A Multi-Stage, Randomized, Single Blind, Pilot study of the Acute Effects of Guided Imagery and Transcranial Direct Current Stimulation (tDCS) on EEG Alpha Brain Waves and Pain Levels in Women with Chronic Pelvic Pain, referred to as Part
* 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 treatment and follow up periods.
* Subject agrees to maintain stable doses of all current medications throughout the treatment and follow-up period.

Exclusion Criteria:

* History of seizures during the last 2 years or diagnosis of epilepsy
* Pacemaker
* Currently using tobacco
* 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' judgement 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 per investigator's clinical judgment, 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 four 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 of more of the eligibility criteria have been left off this list posting while the trial is ongoing. A full list of eligibility criteria will be posted upon completion of the trial.

Primary outcomes:
measure: To assess changes in EEG alpha brain waves in women with CPP after 5 sessions of transcranial direct simulation (tDCS) administered concurrently with guided imagery (GI).
timeFrame: At 1-week follow up visit.
Secondary outcomes:
measure: To assess changes in pain in women with CPP after 5 sessions of transcranial direct simulation (tDCS) administered concurrently with guided imagery (GI).
timeFrame: At 1-week follow-up.
measure: To assess changes in urinary symptoms in women with CPP after 5 sessions of transcranial direct simulation (tDCS) administered concurrently with guided imagery (GI) as measured by the Overactive Bladder Questionnaire short form (OAB-q SF).
timeFrame: At 1-week follow-up visit.
measure: To assess changes in urinary symptoms in women with CPP after 5 sessions of transcranial direct simulation (tDCS) administered concurrently with guided imagery (GI) as measured by the Interstitial Cystitis Symptom Index and Problem Index ICSI-PI).
timeFrame: At 1-week follow-up visit.
measure: To assess changes in QOL in women with CPP after 5 sessions of transcranial direct simulation (tDCS) administered concurrently with guided imagery (GI).
timeFrame: At 1-week follow-up visit.
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: Beaumont Health System
state: Michigan
city: Royal Oak
country: United States
facility: Beaumont Hospital-Royal Oak
state: Michigan
Study officials:
affiliation: Beaumont Health
name: Kenneth M Peters, MD
role: PRINCIPAL_INVESTIGATOR
References: