Modulation of Fear Extinction Processes Using Transcranial Electrical Stimulation

NCT02723188 | Completed Results

• 1 other identifier: TASMC-13-TH-334
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stress Related Disorder; Anxiety

Outcome Measures

Primary Outcomes (1)

• Galvanic Skin Response (GSR)

  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).

  During three-day experimental task

Secondary Outcomes (1)

• Self-reported Fear Rankings

  During three-day experimental task

Study Arms (3)

Sham

SHAM COMPARATOR

Sham electrical stimulation

Device: Sham stimulation (1.5 milliampere,30 seconds)

DC: Direct current

EXPERIMENTAL

Direct current electrical stimulation

Device: DC stimulation (1.5 milliampere, 20 minutes)

AC: Alternating current

EXPERIMENTAL

Alternating current electrical stimulation

Device: AC stimulation (1.5 milliampere,1.5 Hertz frequency)

Interventions

Sham stimulation (1.5 milliampere,30 seconds) DEVICE

Also known as: DC Stimulator Plus (neuroConn, Germany), serial 0118

Sham

DC stimulation (1.5 milliampere, 20 minutes) DEVICE

Also known as: DC Stimulator Plus (neuroConn, Germany), serial 0118

DC: Direct current

AC stimulation (1.5 milliampere,1.5 Hertz frequency) DEVICE

Also known as: DC Stimulator Plus (neuroConn, Germany), serial 0118

AC: Alternating current

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

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

Sponsors & Collaborators

• Tel Aviv University: lead

Related Publications (1)

• 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.

  PMID: 27727241 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Results Point of Contact

• Title: Yair Bar-Haim
• Organization: Tel Aviv University

yair1@post.tau.ac.il

97236406393

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Study Record Dates

• First Submitted: March 24, 2016
• First Posted: March 30, 2016
• Study Start: September 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: June 14, 2017
• Results First Posted: June 14, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share