Modulation of Fear Extinction Processes Using Transcranial Electrical Stimulation

NCT ID: NCT02723188

Last Updated: 2017-06-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Stress Related Disorder Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Sham

Sham electrical stimulation

Group Type SHAM_COMPARATOR

Sham stimulation (1.5 milliampere,30 seconds)

Intervention Type DEVICE

DC: Direct current

Direct current electrical stimulation

Group Type EXPERIMENTAL

DC stimulation (1.5 milliampere, 20 minutes)

Intervention Type DEVICE

AC: Alternating current

Alternating current electrical stimulation

Group Type EXPERIMENTAL

AC stimulation (1.5 milliampere,1.5 Hertz frequency)

Intervention Type DEVICE

Interventions

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Sham stimulation (1.5 milliampere,30 seconds)

Intervention Type DEVICE

DC stimulation (1.5 milliampere, 20 minutes)

Intervention Type DEVICE

AC stimulation (1.5 milliampere,1.5 Hertz frequency)

Intervention Type DEVICE

Other Intervention Names

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DC Stimulator Plus (neuroConn, Germany), serial 0118 DC Stimulator Plus (neuroConn, Germany), serial 0118 DC Stimulator Plus (neuroConn, Germany), serial 0118

Eligibility Criteria

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Exclusion Criteria

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

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tel Aviv University

OTHER

Sponsor Role lead

Responsible Party

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Yair Bar-Haim

Professor of Psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Abend R, Jalon I, Gurevitch G, Sar-El R, Shechner T, Pine DS, Hendler T, Bar-Haim Y. Modulation of fear extinction processes using transcranial electrical stimulation. Transl Psychiatry. 2016 Oct 11;6(10):e913. doi: 10.1038/tp.2016.197.

Reference Type DERIVED
PMID: 27727241 (View on PubMed)

Other Identifiers

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TASMC-13-TH-334

Identifier Type: -

Identifier Source: org_study_id

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