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Modulation of Fear Extinction Processes Using Transcranial Electrical Stimulation

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ClinicalTrials.gov Identifier: NCT02723188
Recruitment Status : Completed
First Posted : March 30, 2016
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
Yair Bar-Haim, Tel Aviv University

Brief Summary:
The aim of this study is to examine the effects of transcranial electrical stimulation on processes associated with fear extinction in healthy humans.

Condition or disease Intervention/treatment Phase
Stress Related Disorder Anxiety Device: Sham stimulation (1.5 milliampere,30 seconds) Device: DC stimulation (1.5 milliampere, 20 minutes) Device: AC stimulation (1.5 milliampere,1.5 Hertz frequency) Not Applicable

Detailed Description:
Research links the processes of fear conditioning and extinction to the treatment of anxiety and stress-related disorders. Moreover, considerable translational research examines the neural correlates of these processes. However, virtually no research in humans manipulates neural correlates of these processes, which limits basic-clinical integration. The present study aimed to use transcranial electrical stimulation (tES) to modulate processes associated with fear extinction in order to assess the potential utility of tES in enhancing exposure-based treatment. To this end, healthy participants underwent a three-day fear conditioning and extinction paradigm. Participants were randomly assigned into 3 groups, differing in terms of tES applied during the extinction learning phase (Day 2) and targeting the medial prefrontal cortex: 1) direct current (DC) stimulation, aimed at enhancing extinction learning; 2) alternate current (AC) stimulation, aimed at interfering with reconsolidation of the fear memory activated during the extinction phase; and 3) sham stimulation. The outcome measures (outlined next) involve the assessment of extinction recall during a test phase (Day 3). Successful modulation of extinction learning by tES would be reflected in enhanced extinction recall.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Modulation of Fear Extinction Processes Using Transcranial Electrical Stimulation
Study Start Date : September 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Sham Comparator: Sham
Sham electrical stimulation
Device: Sham stimulation (1.5 milliampere,30 seconds)
Other Name: DC Stimulator Plus (neuroConn, Germany), serial 0118

Experimental: DC: Direct current
Direct current electrical stimulation
Device: DC stimulation (1.5 milliampere, 20 minutes)
Other Name: DC Stimulator Plus (neuroConn, Germany), serial 0118

Experimental: AC: Alternating current
Alternating current electrical stimulation
Device: AC stimulation (1.5 milliampere,1.5 Hertz frequency)
Other Name: DC Stimulator Plus (neuroConn, Germany), serial 0118




Primary Outcome Measures :
  1. Galvanic Skin Response (GSR) [ Time Frame: During three-day experimental task ]

    GSR was measured throughout the task using 2 standard electrodes on the fingers. Measurement units were in micro-Siemens; scores were square-root-transformed (a common method in GSR studies). A higher level of GSR in response to stimuli is taken to reflect greater physiological fear response, and thus worse in the context of the relevance of the study conditions to the treatment of anxiety disorders.

    Scores were collected in response to presentation of the CS+ (the stimulus conditioned to be associated with an aversive outcome) and the CS- (the stimulus not conditioned to be associated with any outcome).



Secondary Outcome Measures :
  1. Self-reported Fear Rankings [ Time Frame: During three-day experimental task ]

    Participants marked how fearful they are of stimuli used in the task on a single 10-point scale (1=not afraid, 10=extremely afraid). Higher scores therefore reflect greater fear and are worse in the context of treatment for anxiety disorders.

    Scores were collected in response to presentation of the CS+ (the stimulus conditioned to be associated with an aversive outcome) and the CS- (the stimulus not conditioned to be associated with any outcome).




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Exclusion Criteria:

  • Self-reported major psychiatric condition
  • Screening specific for electrical stimulation (psychotropic medication, metal implants in head, epilepsy or seizure history)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yair Bar-Haim, Professor of Psychology, Tel Aviv University
ClinicalTrials.gov Identifier: NCT02723188     History of Changes
Other Study ID Numbers: TASMC-13-TH-334
First Posted: March 30, 2016    Key Record Dates
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Psychophysiologic Disorders
Neurologic Manifestations
Signs and Symptoms