Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2026-03-02 @ 4:55 PM
Study NCT ID:
NCT02781103
Status:
TERMINATED
Last Update Posted:
2019-10-02
First Post:
2016-05-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Guided Imagery and Transcranial Direct Current Stimulation (tDCS) in Women With Chronic Pelvic Pain
Sponsor:
Kenneth M Peters, MD
Organization:
Study Overview
Official Title:
A Randomized Control, Single Blind, Pilot Study of Electroencephalogram (EEG) and Symptoms After Guided Imagery and Transcranial Direct Current Stimulation (tDCS) in Women With Chronic Pelvic Pain
Status:
TERMINATED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single blind, randomized controlled pilot trial of transcranial direct stimulation (tDCS) intervention or tDCS sham administered with a standardized guided imagery intervention. Up to 25 adult women with chronic pelvic pain will be enrolled and randomized (like a flip of the coin) to achieve a total sample size of 20 women. 10 women in one arm of the study will receive guided imagery with tDCS stimulation. 10 women in the other arm of the study will receive guided imagery with sham tDCS. Subjects will remain blinded until the end of the study.
Detailed Description:
Chronic pelvic pain (CPP) is a common and often debilitating problem among women. It occurs below the umbilicus and is severe enough to cause functional impairment or require treatment. One of the challenges of treating women with CPP is that a single cause is often lacking. CPP presents as a syndrome of symptoms involving gynecologic, gastrointestinal, urologic, and musculoskeletal symptoms as well as psychosocial conditions such as depression that negatively impact quality of life.
The study will consist of one screening visit that may be divided into two visits if needed to accommodate subject's schedules. The screening visit(s) should take place within four weeks prior to starting the intervention schedule. The following will be completed at the screening visit(s): pelvic/levator exam, body mass index (BMI), last menstrual period, medication use, electroencephalogram (EEG), questionnaires (CAGE-AID Questionnaire, Beck Depression Inventory, Interstitial Cystitis Symptom/Problem Index, Generalized Anxiety Disorder 7 item scale, McGill Pain Questionnaire, Pain Catastrophizing Scale, Visual Analog Scale for pain). The subject will complete 16 intervention visits over 12 weeks.
The study intervention visits will be conducted on the Beaumont Hospital- Royal Oak campus by licensed nurses and/or physicians. The initial 10 sessions will occur Monday through Friday, within a 21-day period (allowing for missed days due to unexpected emergencies and/or inclement weather). Excluding weekends, there should be no more than 2 days between the intervention sessions. Each intervention is 20 minutes in duration. After completing the initial 10 sessions, subjects will complete an additional 6 weekly maintenance sessions according to treatment group.
Objectives:
1. To assess the change in EEG alpha brain waves in women with CPP after guided imagery sessions with tDCS actual or sham treatments.
2. To assess the change in pain, urinary symptoms, and quality of life in women after guided imagery sessions with tDCS actual or sham sessions.
Endpoints:
Primary objective/endpoint: Change in alpha wave frequency on EEG after 10 sessions of tDCS and guided imagery, versus 10 sessions of sham tDCS and guided imagery compared to baseline.
Secondary objective/endpoint:
Change in pain levels (0-10) on a Visual Analog Scale (VAS) after 10 intervention sessions and at end of study compared to baseline.
Hypothesis:
The combination of tDCS and Guided Imagery (GI) will enhance patient outcomes, as evidenced by differences in alpha brain wave changes, pain and quality of life (QOL) measures between tDCS actual and sham treatment groups.
The study will consist of one screening visit that may be divided into two visits if needed to accommodate subject's schedules. The screening visit(s) should take place within four weeks prior to starting the intervention schedule. The following will be completed at the screening visit(s): pelvic/levator exam, body mass index (BMI), last menstrual period, medication use, electroencephalogram (EEG), questionnaires (CAGE-AID Questionnaire, Beck Depression Inventory, Interstitial Cystitis Symptom/Problem Index, Generalized Anxiety Disorder 7 item scale, McGill Pain Questionnaire, Pain Catastrophizing Scale, Visual Analog Scale for pain). The subject will complete 16 intervention visits over 12 weeks.
The study intervention visits will be conducted on the Beaumont Hospital- Royal Oak campus by licensed nurses and/or physicians. The initial 10 sessions will occur Monday through Friday, within a 21-day period (allowing for missed days due to unexpected emergencies and/or inclement weather). Excluding weekends, there should be no more than 2 days between the intervention sessions. Each intervention is 20 minutes in duration. After completing the initial 10 sessions, subjects will complete an additional 6 weekly maintenance sessions according to treatment group.
Objectives:
1. To assess the change in EEG alpha brain waves in women with CPP after guided imagery sessions with tDCS actual or sham treatments.
2. To assess the change in pain, urinary symptoms, and quality of life in women after guided imagery sessions with tDCS actual or sham sessions.
Endpoints:
Primary objective/endpoint: Change in alpha wave frequency on EEG after 10 sessions of tDCS and guided imagery, versus 10 sessions of sham tDCS and guided imagery compared to baseline.
Secondary objective/endpoint:
Change in pain levels (0-10) on a Visual Analog Scale (VAS) after 10 intervention sessions and at end of study compared to baseline.
Hypothesis:
The combination of tDCS and Guided Imagery (GI) will enhance patient outcomes, as evidenced by differences in alpha brain wave changes, pain and quality of life (QOL) measures between tDCS actual and sham treatment groups.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: