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Open Label Extension Study of tDCS Plus Guided Imagery for Women With Chronic Pelvic Pain (CPP)

Primary Purpose

Chronic Pelvic Pain

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active tDCS with guided imagery
Sponsored by
William Beaumont Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pelvic Pain

Eligibility Criteria

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

Inclusion Criteria:

  • Study participants must have participated and completed: (IRB 2019-362) A Multi-Stage, Randomized, Single Blind, Pilot study of the Acute Effects of Guided Imagery and Transcranial Direct Current Stimulation (tDCS) on EEG Alpha Brain Waves and Pain Levels in Women with Chronic Pelvic Pain, referred to as Part
  • Female
  • Age 18 to 64 years
  • Women must either be unable to become pregnant (are 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 non-cyclical and of at least 6 months duration and refractory to other treatments
  • Subject agrees to not start any new treatment (medication or otherwise) throughout the treatment and follow up periods.
  • Subject agrees to maintain stable doses of all current medications throughout the treatment and follow-up period.

Exclusion Criteria:

  • History of seizures during the last 2 years or diagnosis of epilepsy
  • Pacemaker
  • Currently using tobacco
  • 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' judgement 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

  1. If a subject has a confirmed UTI per investigator's clinical judgment, she will be deferred until treatment is completed and symptoms resolve
  2. Participating in another intervention study, or received an investigational drug or device within 4 weeks prior to screening
  3. Subject received bladder hydrodistention within the past 12 weeks
  4. Within the past four weeks, initiation of any new medications or any intravesical treatment for treatment of IC/BPS.

  5. 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 of more of the eligibility criteria have been left off this list posting 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 Type

Experimental

Arm Label

Active tDCS with guided imagery

Arm Description

Subjects will receive 2 miliamps 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.

Outcomes

Primary Outcome Measures

To assess changes in EEG alpha brain waves in women with CPP after 5 sessions of transcranial direct simulation (tDCS) administered concurrently with guided imagery (GI).
Change in alpha wave frequency on EEG between baseline and after the 5th interventional treatment of tDCS with guided imagery.

Secondary Outcome Measures

To assess changes in pain in women with CPP after 5 sessions of transcranial direct simulation (tDCS) administered concurrently with guided imagery (GI).
A 10-point VAS for pain will be utilized at screening to determine eligibility, and pre- and post-treatment to measure the short-term effects of each treatment. VAS is scored from 0-10.
To assess changes in urinary symptoms in women with CPP after 5 sessions of transcranial direct simulation (tDCS) administered concurrently with guided imagery (GI) as measured by the Overactive Bladder Questionnaire short form (OAB-q SF).
Changes in subject-reported bother related to overactive bladder symptoms as measured by the Overactive Bladder Questionnaire short form (OAB-q SF). The OAB-q SF consists of two scales assessing symptom bother and health-related quality of life (HRQOL) in patients with OAB. Each question is rated on a 6-point scale with 1 = not at all and 6= a very great deal.
To assess changes in urinary symptoms in women with CPP after 5 sessions of transcranial direct simulation (tDCS) administered concurrently with guided imagery (GI) as measured by the Interstitial Cystitis Symptom Index and Problem Index ICSI-PI).
The IC symptom and problem index measure urinary and pain symptoms and assess how problematic symptoms are for patients with IC/BPS. Scored (0-36). A higher score indicates greater severity of symptoms.
To assess changes in QOL in women with CPP after 5 sessions of transcranial direct simulation (tDCS) administered concurrently with guided imagery (GI).
The Global Response Assessments (GRA) for Pain and QOL will administered. GRA evaluates the subject's perceptions of overall improvement in symptoms on a 7-point scale (markedly worse, moderately worse, mildly worse, same, slightly improved, moderately improved, or markedly improved).

Full Information

First Posted
January 27, 2020
Last Updated
November 19, 2022
Sponsor
William Beaumont Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT04252040
Brief Title
Open Label Extension Study of tDCS Plus Guided Imagery for Women With Chronic Pelvic Pain (CPP)
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
Lack of participants. No enrollment
Study Start Date
March 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
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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 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. 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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is an open label extension exploratory study. All eligible subjects will receive active tDCS with guided imagery.
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active tDCS with guided imagery
Arm Type
Experimental
Arm Description
Subjects will receive 2 miliamps 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.
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 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.
Primary Outcome Measure Information:
Title
To assess changes in EEG alpha brain waves in women with CPP after 5 sessions of transcranial direct simulation (tDCS) administered concurrently with guided imagery (GI).
Description
Change in alpha wave frequency on EEG between baseline and after the 5th interventional treatment of tDCS with guided imagery.
Time Frame
At 1-week follow up visit.
Secondary Outcome Measure Information:
Title
To assess changes in pain in women with CPP after 5 sessions of transcranial direct simulation (tDCS) administered concurrently with guided imagery (GI).
Description
A 10-point VAS for pain will be utilized at screening to determine eligibility, and pre- and post-treatment to measure the short-term effects of each treatment. VAS is scored from 0-10.
Time Frame
At 1-week follow-up.
Title
To assess changes in urinary symptoms in women with CPP after 5 sessions of transcranial direct simulation (tDCS) administered concurrently with guided imagery (GI) as measured by the Overactive Bladder Questionnaire short form (OAB-q SF).
Description
Changes in subject-reported bother related to overactive bladder symptoms as measured by the Overactive Bladder Questionnaire short form (OAB-q SF). The OAB-q SF consists of two scales assessing symptom bother and health-related quality of life (HRQOL) in patients with OAB. Each question is rated on a 6-point scale with 1 = not at all and 6= a very great deal.
Time Frame
At 1-week follow-up visit.
Title
To assess changes in urinary symptoms in women with CPP after 5 sessions of transcranial direct simulation (tDCS) administered concurrently with guided imagery (GI) as measured by the Interstitial Cystitis Symptom Index and Problem Index ICSI-PI).
Description
The IC symptom and problem index measure urinary and pain symptoms and assess how problematic symptoms are for patients with IC/BPS. Scored (0-36). A higher score indicates greater severity of symptoms.
Time Frame
At 1-week follow-up visit.
Title
To assess changes in QOL in women with CPP after 5 sessions of transcranial direct simulation (tDCS) administered concurrently with guided imagery (GI).
Description
The Global Response Assessments (GRA) for Pain and QOL will administered. GRA evaluates the subject's perceptions of overall improvement in symptoms on a 7-point scale (markedly worse, moderately worse, mildly worse, same, slightly improved, moderately improved, or markedly improved).
Time Frame
At 1-week follow-up visit.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Study participants must have participated and completed: (IRB 2019-362) A Multi-Stage, Randomized, Single Blind, Pilot study of the Acute Effects of Guided Imagery and Transcranial Direct Current Stimulation (tDCS) on EEG Alpha Brain Waves and Pain Levels in Women with Chronic Pelvic Pain, referred to as Part Female Age 18 to 64 years Women must either be unable to become pregnant (are 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 non-cyclical and of at least 6 months duration and refractory to other treatments Subject agrees to not start any new treatment (medication or otherwise) throughout the treatment and follow up periods. Subject agrees to maintain stable doses of all current medications throughout the treatment and follow-up period. Exclusion Criteria: History of seizures during the last 2 years or diagnosis of epilepsy Pacemaker Currently using tobacco 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' judgement 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 per investigator's clinical judgment, 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 four 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 of more of the eligibility criteria have been left off this list posting 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
No

Learn more about this trial

Open Label Extension Study of tDCS Plus Guided Imagery for Women With Chronic Pelvic Pain (CPP)

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