Pelvic PainNCT04250662
Study of the Acute Effects of Guided Imagery and tDCS on Pain Levels in Women With Chronic Pelvic Pain
A study testing Active tDCS with guided imagery and Active tDCS alone (no guided imagery) in people with Pelvic Pain and Chronic Pain, run by Corewell Health East at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Pelvic Pain, Chronic Pain
- What is being tested?
- Active tDCS with guided imagery and Active tDCS alone (no guided imagery)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2020to 17 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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
- Within the past 24 weeks received any surgery or procedure which may impact the pelvic floor
- Note: For the sake of preserving scientific integrity, one or more of the eligibility criteria have been left off the list posted while the trial is ongoing. A full list of eligibility criteria will be posted upon completion of the trial.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Beaumont Health System
Royal Oak, Michigan, 48073
Beaumont Hospital-Royal Oak
Royal Oak, Michigan, 48073
About this study
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
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).
Read the detailed description
Chronic Pelvic Pain (CPP) is a common and often debilitating problem among women. CPP is pain that is felt below the belly button and is severe enough to cause feelings of pressure, pain while sitting or standing for long periods of time, pain with intercourse, painful urination, and pain with bowel movements. Transcranial Direct Current Simulation (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.
The study will consist of one visit. After informed consent is obtained, the following will be collected/completed: health history, demographics, vitals, and questionnaires (BDI, CAGE-AID, PCS, and VAS for pelvic pain). A urinalysis will be collected to assess for infection and a urine pregnancy test for women of child bearing potential. If a subject qualifies they will be randomized. Before treatment, subjects complete an EEG. Treatment will be delivered based on randomization group assignment. After treatment an EEG, VAS, GRA will be collected. Study staff will assess for adverse events during and after treatment.
- Conditions
- Pelvic Pain, Chronic Pain
- Being tested
- Active tDCS with guided imagery, Active tDCS alone (no guided imagery), Sham tDCS with guided imagery, Sham tDCS alone (no guided imagery)
- Medical subject headings
- Pelvic Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tDCS with guided imageryDevice
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.
Active tDCS alone (no guided imagery)Device
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.
Sham tDCS with guided imageryDevice
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.
Sham tDCS alone (no guided imagery)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS with guided imagery | Experimental | Subjects 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. Receives: Device: Active tDCS with guided imagery |
| Active tDCS alone (no guided imagery) | Experimental | Subjects 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. Receives: Device: Active tDCS alone (no guided imagery) |
| Sham tDCS with guided imagery | Sham comparator | Subjects 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. Receives: Device: Sham tDCS with guided imagery |
| Sham tDCS alone (no guided imagery) | Sham comparator | Subjects 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. Receives: Device: Sham tDCS alone (no guided imagery) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Change in pain levels (0-10) on a Visual Analog Scale (VAS) between pre-treatment and post-treatment.
Measured: Baseline and 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study startFeb 2020 (estimated)
- Primary completion17 Nov 2022
- Study completion17 Nov 2022
Why it stopped: No participants enrolled. Lack of patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- A single blind, randomized control, exploratory trial to assess the acute effects of tDCS and guided imagery in women with chronic pelvic pain. Qualified individuals will be randomized 1:1:1:1 to receive 1 session of one of the following treatments: * 20 minutes of active tDCS with 25 minutes of guided imagery * 20 minutes of active tDCS with no guided imagery * 20 minutes of sham tDCS with 25 minutes of guided imagery * 20 minutes of sham tDCS with no guided imagery
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth M Peters, MD, Corewell Health East
- Investigators
- Kenneth M Peters, MD, Principal investigator, Beaumont Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04250662
- Sponsor's protocol ID
- 2019-362
- Status last verified
- Nov 2022
- First submitted
- 27 Jan 2020
- Last updated
- 23 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04250662
- Acronym / sponsor ID
- 2019-362
- Conditions
- Pelvic Pain, Chronic Pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled. Lack of patients.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- Feb 2020 (estimated)
- Primary completion
- 17 Nov 2022 (actual)
- Study completion
- 17 Nov 2022 (actual)
- First posted
- 31 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Chronic Pelvic Pain (CPP) is a common and often debilitating problem among women. CPP is pain that is felt below the belly button and is severe enough to cause feelings of pressure, pain while sitting or standing for long periods of time, pain with intercourse, painful urination, and pain with bowel movements. Transcranial Direct Current Simulation (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.
The study will consist of one visit. After informed consent is obtained, the following will be collected/completed: health history, demographics, vitals, and questionnaires (BDI, CAGE-AID, PCS, and VAS for pelvic pain). A urinalysis will be collected to assess for infection and a urine pregnancy test for women of child bearing potential. If a subject qualifies they will be randomized. Before treatment, subjects complete an EEG. Treatment will be delivered based on randomization group assignment. After treatment an EEG, VAS, GRA will be collected. Study staff will assess for adverse events during and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- A single blind, randomized control, exploratory trial to assess the acute effects of tDCS and guided imagery in women with chronic pelvic pain. Qualified individuals will be randomized 1:1:1:1 to receive 1 session of one of the following treatments: * 20 minutes of active tDCS with 25 minutes of guided imagery * 20 minutes of active tDCS with no guided imagery * 20 minutes of sham tDCS with 25 minutes of guided imagery * 20 minutes of sham tDCS with no guided imagery
| Arm | Type | Receives |
|---|---|---|
| Active tDCS with guided imagery | Experimental | Device: Active tDCS with guided imagerySubjects 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) | Experimental | Device: Active tDCS alone (no guided imagery)Subjects 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 comparator | Device: Sham tDCS with guided imagerySubjects 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 comparator | Device: Sham tDCS alone (no guided imagery)Subjects 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active tDCS with guided imageryThe 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. | Device | Active tDCS with guided imagery |
| Active tDCS alone (no 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. | Device | Active tDCS alone (no guided imagery) |
| Sham tDCS with guided imageryThe 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. | Device | Sham tDCS with guided imagery |
| Sham tDCS alone (no 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. | Device | Sham tDCS alone (no guided imagery) |
Primary outcome
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).
Time frame: Baseline and 48 hours
An EEG will be collected prior to treatment and after treatment. Changes in alpha waves will be assessed.
1 secondary outcome
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).
Time frame: Baseline and 48 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth M Peters, MD principal investigator
Beaumont Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active tDCS with guided imagery and Active tDCS alone (no guided imagery) in people with Pelvic Pain and Chronic Pain, run by Corewell Health East at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: Baseline and 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2022.