Open Label Extension Study of tDCS Plus Guided Imagery for Women With Chronic Pelvic Pain (CPP)
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|ClinicalTrials.gov Identifier: NCT04252040|
Recruitment Status : Not yet recruiting
First Posted : February 5, 2020
Last Update Posted : May 20, 2020
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pelvic Pain||Device: Active tDCS with guided imagery||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is an open label extension exploratory study. All eligible subjects will receive active tDCS with guided imagery.|
|Masking:||None (Open Label)|
|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|
|Estimated Study Start Date :||September 2020|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2022|
Experimental: Active tDCS with guided imagery
Subjects will receive 2 miliamps 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.
Device: Active tDCS with guided imagery
The subject will be positioned in the sitting/reclining position in a quiet room with lights dimmed. The tDCS device and audio headphones will be placed on the subject's head. The tDCS device to be used is the Soterix Medical 1X1 device using 2.0 mA of current. The electrodes that will be used will be standard sponge electrodes. The subject will listen to a scripted guided imagery CD specifically developed for women with chronic pelvic pain through the audio headphones. The guided imagery plus active tDCS arm will have 20 minutes of stimulation with 25 minutes of guided imagery.
- 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). [ Time Frame: At 1-week follow up visit. ]Change in alpha wave frequency on EEG between baseline and after the 5th interventional treatment of tDCS with guided imagery.
- To assess changes in pain in women with CPP after 5 sessions of transcranial direct simulation (tDCS) administered concurrently with guided imagery (GI). [ Time Frame: At 1-week follow-up. ]A 10-point VAS for pain will be utilized at screening to determine eligibility, and pre- and post-treatment to measure the short-term effects of each treatment. VAS is scored from 0-10.
- 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). [ Time Frame: At 1-week follow-up visit. ]Changes in subject-reported bother related to overactive bladder symptoms as measured by the Overactive Bladder Questionnaire short form (OAB-q SF). The OAB-q SF consists of two scales assessing symptom bother and health-related quality of life (HRQOL) in patients with OAB. Each question is rated on a 6-point scale with 1 = not at all and 6= a very great deal.
- 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). [ Time Frame: At 1-week follow-up visit. ]The IC symptom and problem index measure urinary and pain symptoms and assess how problematic symptoms are for patients with IC/BPS. Scored (0-36). A higher score indicates greater severity of symptoms.
- To assess changes in QOL in women with CPP after 5 sessions of transcranial direct simulation (tDCS) administered concurrently with guided imagery (GI). [ Time Frame: At 1-week follow-up visit. ]The Global Response Assessments (GRA) for Pain and QOL will administered. GRA evaluates the subject's perceptions of overall improvement in symptoms on a 7-point scale (markedly worse, moderately worse, mildly worse, same, slightly improved, moderately improved, or markedly improved).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04252040
|Contact: Evelyn Sheaemail@example.com|
|Contact: Jennifer Giordano, RN, BSN||248-551-3517||Jennifer.Giordano@beaumont.org|
|United States, Michigan|
|Beaumont Health System|
|Royal Oak, Michigan, United States, 48073|
|Beaumont Hospital-Royal Oak|
|Royal Oak, Michigan, United States, 48073|
|Principal Investigator:||Kenneth M Peters, MD||Beaumont Health|