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

NCT04252040 | Withdrawn FDA Device

• 1 other identifier: 2019-382
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Pelvic Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  At 1-week follow up visit.

Secondary Outcomes (4)

• To assess changes in pain in women with CPP after 5 sessions of transcranial direct simulation (tDCS) administered concurrently with guided imagery (GI).

  At 1-week follow-up.

• 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).

  At 1-week follow-up visit.

• 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).

  At 1-week follow-up visit.

• To assess changes in QOL in women with CPP after 5 sessions of transcranial direct simulation (tDCS) administered concurrently with guided imagery (GI).

  At 1-week follow-up visit.

Study Arms (1)

Active tDCS with guided imagery

EXPERIMENTAL

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.

Device: Active tDCS with guided imagery

Interventions

Active tDCS with guided imagery DEVICE

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.

Active tDCS with guided imagery

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (2)

Beaumont Health System

Royal Oak, Michigan, 48073, United States

Location

Beaumont Hospital-Royal Oak

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Interventions

Imagery, Psychotherapy

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director and Chair of the Department of Urology

Model Details: This is an open label extension exploratory study. All eligible subjects will receive active tDCS with guided imagery.

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: February 5, 2020
• Study Start: March 1, 2020
• Primary Completion: November 17, 2022
• Study Completion: November 17, 2022
• Last Updated: November 23, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)