Study Stopped
No participants enrolled. Lack of patients.
Study of the Acute Effects of Guided Imagery and tDCS on Pain Levels in Women With Chronic Pelvic Pain
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
1 other identifier
interventional
N/A
1 country
2
Brief Summary
This is a single blind, randomized, exploratory study of transcranial direct stimulation (tDCS) intervention or sham tDCS administered with a standardized guided imagery intervention for chronic pelvic pain. Transcranial Direct Current Sstimulation (tDCS) is a non-invasive brain stimulation therapy. Guided Imagery is a form of hypnosis used to create relaxation.Up to 25 adult women with chronic pelvic pain will be enrolled and randomized (like a flip of a coin). Subjects will remain blinded throughout the study. Subjects will be randomized into one of the following four arms: active tDCS with guided imagery, active tDCS alone (without guided imagery), sham tDCS with guided imagery, or sham tDCS alone (without guided imagery).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Feb 2020
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2020
CompletedFirst Posted
Study publicly available on registry
January 31, 2020
CompletedStudy Start
First participant enrolled
February 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 17, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 17, 2022
CompletedNovember 23, 2022
November 1, 2022
2.8 years
January 27, 2020
November 19, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
To access the acute changes in EEG alpha brain waves in women with CPP after 1 session of each of the following treatments: (1) active tDCS + GI, (2) sham tDCS + GI, (3) sham tDCS alone (no GI) and (4)active tDCS alone (no GI).
An EEG will be collected prior to treatment and after treatment. Changes in alpha waves will be assessed.
Baseline and 48 hours
Secondary Outcomes (1)
To access acute changes in pain in women with CPP after 1 session of each of the following treatments: (1) active tDCS + GI, (2) sham tDCS + GI, (3) sham tDCS alone (no GI) and (4)active tDCS alone (no GI).
Baseline and 48 hours
Study Arms (4)
Active tDCS with guided imagery
EXPERIMENTALSubjects will receive 2 milliamps 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.
Active tDCS alone (no guided imagery)
EXPERIMENTALSubjects will receive 2 milliamps of electrical stimulation to the brain (transcranial direct stimulation-tDCS) for 20 minutes while remaining seated, no guided imagery will be provided.
Sham tDCS with guided imagery
SHAM COMPARATORSubjects will receive 2 milliamps of electrical stimulation to the brain (transcranial direct stimulation-tDCS) for only 30 seconds and then the device will turn off. The device will remain in place, however, for 25 minutes the subject listens to a guided imagery CD specifically designed for women with chronic pelvic pain.
Sham tDCS alone (no guided imagery)
SHAM COMPARATORSubjects will receive 2 milliamps of electrical stimulation to the brain (transcranial direct stimulation-tDCS) for only 30 seconds and then the device will turn off. The device will remain in place, however, for 25 minutes the subject will remain seated, no guided imagery will be provided.
Interventions
The subject will be positioned in the sitting/reclining position in a quiet room with the 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.
The subject will be positioned in the sitting/reclining position in a quiet room with the lights dimmed. The tDCS device 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. Active tDCS arm alone without guided imagery, will have 20 minutes of tDCS stimulation without guided imagery.
The subject will be positioned in the sitting/reclining position in a quiet room with the 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 sham tDCS arm will have 30 seconds of tDCS stimulation with 25 minutes of guided imagery.
The subject will be positioned in the sitting/reclining position in a quiet room with the lights dimmed. The tDCS device 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. Sham tDCS alone arm will have 30 seconds of tDCS stimulation without guided imagery.
Eligibility Criteria
You may qualify if:
- Female
- Age 18 to 64 years
- Women must either be unable to become pregnant (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 not related to menstrual cycle and of at lease 6 months duration and refractory to other treatments.
- Subject agrees to not start any new treatments (medication or otherwise) throughout the study participation.
- Subject agrees to maintain stable doses of all current medications throughout study participation.
You may not qualify if:
- History of seizures during the last 2 years or diagnosis of epilepsy
- Pacemaker
- 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' judgment, 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
- If a subject has a confirmed UTI, she will be deferred until treatment is completed and symptoms resolve
- Participating in another intervention study, or received an investigational drug or device within 4 weeks prior to screening
- Subject received bladder hydrodistention within the past 12 weeks
- Within the past 4 weeks, initiation of any new medications or any intravesical treatment for treatment of IC/BPS
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Beaumont Health System
Royal Oak, Michigan, 48073, United States
Beaumont Hospital-Royal Oak
Royal Oak, Michigan, 48073, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kenneth M Peters, MD
Beaumont Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Device settings
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director and Chair of the Department of Urology
Study Record Dates
First Submitted
January 27, 2020
First Posted
January 31, 2020
Study Start
February 1, 2020
Primary Completion
November 17, 2022
Study Completion
November 17, 2022
Last Updated
November 23, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share