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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04252040
Study type Interventional
Source William Beaumont Hospitals
Contact
Status Withdrawn
Phase N/A
Start date March 2020
Completion date November 17, 2022

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