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Guided Imagery and Transcranial Direct Current Stimulation (tDCS) in Women With Chronic Pelvic Pain

Primary Purpose

Cystitis, Interstitial, Pelvic Pain

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Guided imagery plus active tDCS
Guided imagery plus Sham tDCS
Sponsored by
Kenneth M Peters, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystitis, Interstitial

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 (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 study treatment and follow up periods.
  • Subject agrees to maintain stable doses of all current medications throughout the study treatment and follow-up period.

Exclusion Criteria:

  • Pacemaker
  • History of seizures during the last 2 years or diagnosis of epilepsy
  • Currently using tobacco
  • Parkinson's Disease
  • Any condition, including neurological or psychiatric illness, which per investigators' judgement may increase subject risk
  • History of Hunner's lesion in the medical record
  • Lactation, pregnancy, or refusal to use medically approved/reliable birth control in women of child-bearing potential
  • Sacral, 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

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 Hospital-Royal Oak

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Guided imagery plus active tDCS

Guided imagery plus Sham tDCS

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 only 30 seconds and then the device will be turned off. The device will remain in place, however, for 20 minutes while the subject listens to a guided imagery CD specifically designed for women with chronic pelvic pain.

Outcomes

Primary Outcome Measures

Change in alpha wave frequency on EEG
Change in alpha wave frequency on EEG between baseline and up to 21 days after the first treatment of tDCS +GI, versus sham tDCS +GI

Secondary Outcome Measures

Change in pain levels on a 0-10 (no pain to most severe pain) Visual Analog Scale (VAS)
Change in pain levels (0-10) on a Visual Analog Scale (VAS) between baseline and up to 21 days after the first treatment of tDCS +GI, versus sham tDCS +GI

Full Information

First Posted
May 12, 2016
Last Updated
September 30, 2019
Sponsor
Kenneth M Peters, MD
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1. Study Identification

Unique Protocol Identification Number
NCT02781103
Brief Title
Guided Imagery and Transcranial Direct Current Stimulation (tDCS) in Women With Chronic Pelvic Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Why Stopped
Lack of enrollment
Study Start Date
January 20, 2017 (Actual)
Primary Completion Date
February 13, 2017 (Actual)
Study Completion Date
September 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kenneth M Peters, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: To assess the change in EEG alpha brain waves in women with CPP after guided imagery sessions with tDCS actual or sham treatments. 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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Guided imagery plus active tDCS
Arm Type
Experimental
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.
Arm Title
Guided imagery plus Sham tDCS
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 be turned off. The device will remain in place, however, for 20 minutes while the subject listens to a guided imagery CD specifically designed for women with chronic pelvic pain.
Intervention Type
Other
Intervention Name(s)
Guided imagery plus active tDCS
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 tDCS for 20 minutes concurrently with Guided Imagery.
Intervention Type
Other
Intervention Name(s)
Guided imagery plus Sham tDCS
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 sham arm will have 30 seconds of tDCS, but after 30 seconds the device will be turned off. The device will remain in place until the subject has listened to 20 minutes of the guided imagery CD.
Primary Outcome Measure Information:
Title
Change in alpha wave frequency on EEG
Description
Change in alpha wave frequency on EEG between baseline and up to 21 days after the first treatment of tDCS +GI, versus sham tDCS +GI
Time Frame
Up to 21 days after the first treatment of tDCS +GI or sham tDCS +GI
Secondary Outcome Measure Information:
Title
Change in pain levels on a 0-10 (no pain to most severe pain) Visual Analog Scale (VAS)
Description
Change in pain levels (0-10) on a Visual Analog Scale (VAS) between baseline and up to 21 days after the first treatment of tDCS +GI, versus sham tDCS +GI
Time Frame
Up to 21 days after the first treatment of tDCS +GI or sham tDCS +GI

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: 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 study treatment and follow up periods. Subject agrees to maintain stable doses of all current medications throughout the study treatment and follow-up period. Exclusion Criteria: Pacemaker History of seizures during the last 2 years or diagnosis of epilepsy Currently using tobacco Parkinson's Disease Any condition, including neurological or psychiatric illness, which per investigators' judgement may increase subject risk History of Hunner's lesion in the medical record Lactation, pregnancy, or refusal to use medically approved/reliable birth control in women of child-bearing potential Sacral, 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 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 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

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Guided Imagery and Transcranial Direct Current Stimulation (tDCS) in Women With Chronic Pelvic Pain

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