Modulation of Fear Extinction Processes Using Transcranial Electrical Stimulation

The Study Assessed the Potential Utility of tES for Enhancing Treatment of Anxiety Disorders. This Preliminary Study Was Conducted Healthy Participants Clinical Trial

Official title:

Modulation of Fear Extinction Processes Using Transcranial Electrical Stimulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02723188
• Other study ID #: TASMC-13-TH-334
• Status: Completed
• Phase: N/A
• First received: March 24, 2016
• Last updated: March 24, 2016
• Start date: September 2014
• Est. completion date: April 2015

Study information

• Verified date: March 2016
• Source: Tel Aviv University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

Exclusion Criteria:

• Self-reported major psychiatric condition

• Screening specific for electrical stimulation (psychotropic medication, metal implants in head, epilepsy or seizure history)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Anxiety Disorders
• The Study Assessed the Potential Utility of tES for Enhancing Treatment of Anxiety Disorders. This Preliminary Study Was Conducted Healthy Participants

Intervention

Device:
• Sham stimulation (1.5 milliampere,30 seconds)

• DC stimulation (1.5 milliampere, 20 minutes)

• AC stimulation (1.5 milliampere,1.5 Hertz frequency)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tel Aviv University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin conductance response	Measured throughout task using 2 standard electrodes on fingers	During three-day experimental task	No
Secondary	Self-reported fear rankings	Participants marked how fearful they are of stimuli used in task (1-7 scale)	During three-day experimental task	No