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Study of the Acute Effects of Guided Imagery and tDCS on Pain Levels in Women With Chronic Pelvic Pain

Primary Purpose

Pelvic Pain, Chronic Pain

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Active tDCS with guided imagery

Active tDCS alone (no guided imagery)

Sham tDCS with guided imagery

Sham tDCS alone (no guided imagery)

About this trial

This is an interventional treatment trial for Pelvic Pain

Eligibility Criteria

18 Years - 64 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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
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.

Sites / Locations

Beaumont Health System
Beaumont Hospital-Royal Oak

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Sham Comparator

Arm Label

Active tDCS with guided imagery

Active tDCS alone (no guided imagery)

Sham tDCS with guided imagery

Sham tDCS alone (no guided imagery)

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04250662

First Posted

January 27, 2020

Last Updated

November 19, 2022

Sponsor

William Beaumont Hospitals

1. Study Identification

Unique Protocol Identification Number

NCT04250662

Brief Title

Study of the Acute Effects of Guided Imagery and tDCS on Pain Levels in Women With Chronic Pelvic Pain

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Withdrawn

Why Stopped

No participants enrolled. Lack of patients.

Study Start Date

February 2020 (Anticipated)

Primary Completion Date

November 17, 2022 (Actual)

Study Completion Date

November 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

William Beaumont Hospitals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pelvic Pain, Chronic Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

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

Participant

Masking Description

Device settings

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active tDCS with guided imagery

Arm Type

Experimental

Arm Description

Arm Title

Active tDCS alone (no guided imagery)

Arm Type

Experimental

Arm Description

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.

Arm Title

Sham tDCS with guided imagery

Arm Type

Sham Comparator

Arm Description

Arm Title

Sham tDCS alone (no guided imagery)

Arm Type

Sham Comparator

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

Active tDCS with guided imagery

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Active tDCS alone (no guided imagery)

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Sham tDCS with guided imagery

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Sham tDCS alone (no guided imagery)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Description

An EEG will be collected prior to treatment and after treatment. Changes in alpha waves will be assessed.

Time Frame

Baseline and 48 hours

Secondary Outcome Measure Information:

Title

Description

Change in pain levels (0-10) on a Visual Analog Scale (VAS) between pre-treatment and post-treatment.

Time Frame

Baseline and 48 hours

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kenneth M Peters, MD

Organizational Affiliation

Beaumont Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beaumont Health System

City

Royal Oak

State/Province

Michigan

ZIP/Postal Code

48073

Country

United States

Facility Name

Beaumont Hospital-Royal Oak

City

Royal Oak

State/Province

Michigan

ZIP/Postal Code

48073

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Study of the Acute Effects of Guided Imagery and tDCS on Pain Levels in Women With Chronic Pelvic Pain

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