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

NCT02781103 | Terminated

• 1 other identifier: 2016-117
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystitis, Interstitial; Pelvic Pain

Outcome Measures

Primary Outcomes (1)

• 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

  Up to 21 days after the first treatment of tDCS +GI or sham tDCS +GI

Secondary Outcomes (1)

• Change in pain levels on a 0-10 (no pain to most severe pain) Visual Analog Scale (VAS)

  Up to 21 days after the first treatment of tDCS +GI or sham tDCS +GI

Study Arms (2)

Guided imagery plus active tDCS

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.

Other: Guided imagery plus active tDCS

Guided imagery plus Sham tDCS

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 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.

Other: Guided imagery plus Sham tDCS

Interventions

Guided imagery plus active tDCS OTHER

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.

Guided imagery plus active tDCS

Guided imagery plus Sham tDCS OTHER

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.

Guided imagery plus Sham tDCS

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kenneth M Peters, MD: lead

Study Sites (1)

Beaumont Hospital-Royal Oak

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Cystitis, Interstitial; Pelvic Pain

Interventions

Imagery, Psychotherapy

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Kenneth M Peters, MD

  Beaumont Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 12, 2016
• First Posted: May 24, 2016
• Study Start: January 20, 2017
• Primary Completion: February 13, 2017
• Study Completion: September 26, 2019
• Last Updated: October 2, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)