Ignite Creation Date:
2024-05-06 @ 2:14 PM
Last Modification Date:
2024-10-26 @ 1:27 PM
Study NCT ID:
NCT04252040
Status:
WITHDRAWN
Last Update Posted:
2022-11-23
First Post:
2020-01-27
Brief Title:
Open Label Extension Study of tDCS Plus Guided Imagery for Women With Chronic Pelvic Pain CPP
Sponsor:
William Beaumont Hospitals
Organization:
William Beaumont Hospitals
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of participants No enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ones 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None