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

NCT02781103 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2019-10-02

No results posted yet for this study

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

Interventions

OTHER

Guided imagery plus active tDCS

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.

OTHER

Guided imagery plus Sham tDCS

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.

Sponsors & Collaborators

  • Kenneth M Peters, MD

    lead OTHER

Principal Investigators

  • Kenneth M Peters, MD · Beaumont Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-20
Primary Completion
2017-02-13
Completion
2019-09-26

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02781103 on ClinicalTrials.gov