NCT02423044

Brief Summary

Background: \- Fear is a normal response to a threat. Learning fear can be helpful sometimes. For people with anxiety disorders, fear can be long-lasting and too intense. Researchers want to study how people become fearful of situations. They want to understand how the brain learns when it is helpful to feel fear and when it is not. Objective: \- To better understand brain processes related to fear and anxiety. Eligibility:

  • Right-handed adults ages 18 50 with generalized anxiety disorder, panic disorder, social anxiety disorder, or post-traumatic stress disorder.
  • Right handed volunteers ages 18-50 without psychiatric disorders.
  • And free of psychiatric medication for 2 weeks Design:
  • Participants will first be screened under another protocol.
  • Participants will play a video game inside a magnetic resonance imaging (MRI) scanner. The scanner is a metal cylinder It is surrounded by a strong magnetic field. Participants will lie on a table that can slide in and out of the scanner. A device called a coil will be placed over the head.
  • During the scan, participants may play a virtual reality video game. Game instructions will be explained before they enter the scanner.
  • While playing the game, participants will wear 2 electrodes on their fingers. These measure sweat on the skin. They will also have 2 small electrodes attached to the left hand. These can give brief mild electrical shocks.
  • Participants will be asked questions when playing the game during the scan.
  • Before and after the scan, participants will fill out questionnaires about their emotions. They may complete questionnaires online while at the clinic.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

April 18, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 22, 2015

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2018

Completed
Last Updated

November 4, 2019

Status Verified

October 30, 2018

Enrollment Period

3.5 years

First QC Date

April 18, 2015

Last Update Submit

November 1, 2019

Conditions

Keywords

AnxietyfMRIVirtual RealityShock ThreatHealthy Volunteer

Outcome Measures

Primary Outcomes (1)

  • The primary objective is to investigate the neural bases of contextual fear learning measures by the event-related hemodynamic response (fMRI).

    12/29/16

Secondary Outcomes (1)

  • The secondary objective is to see learning of the contextual fear response that will be measured by psychophysiological responses such as SCR, heart rate, pupil dilatation, and breathing.

    12/29/16

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Ages 18-50
  • Subjects able to give their consent
  • Right handed
  • Patients only: a primary diagnosis of GAD, panic disorder, SAD, or PTSD according to the Structured Clinical Interview for DSM-IV-TR

You may not qualify if:

  • Non-English speaking individual
  • Any significant medical or neurological problems (e.g. cardiovascular illness, respiratory illness, neurological illness, seizure, etc.)
  • High or low blood pressure (SBP\>140 or SBP\<90; SDP\<50 or SDP\>90)
  • Alcohol/drug abuse in the past year or lifetime alcohol or drug dependence according to the Structured Clinical Interview for DSM-IV-TR
  • Pregnancy or positive pregnancy test
  • Neurological syndrome of the wrist (e.g., carpal tunnel syndrome, cubital tunnel syndrome, etc.)
  • Positive urine toxicology screen
  • IQ \<80
  • Participants who report getting severe motion sickness, especially by playing video games
  • Any medical condition that increases risk for fMRI:
  • Any metal implants (clips, screws, plates, pins, etc) or metal fragments cause by injuries or metal working
  • Any sort of medical implants (aneurysm clips, pacemaker, insulin pump, Hickman line, etc.)
  • Permanent eye liner and tattoos above the neck
  • Patients who have difficulty lying flat on their back for up to 60 min in the scanner
  • Participants who are uncomfortable in small closed spaces (have claustrophobia) and would feel uncomfortable in the MRI machine
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (2)

  • Britton JC, Lissek S, Grillon C, Norcross MA, Pine DS. Development of anxiety: the role of threat appraisal and fear learning. Depress Anxiety. 2011 Jan;28(1):5-17. doi: 10.1002/da.20733. Epub 2010 Aug 23.

    PMID: 20734364BACKGROUND
  • Huff NC, Zeilinski DJ, Fecteau ME, Brady R, LaBar KS. Human fear conditioning conducted in full immersion 3-dimensional virtual reality. J Vis Exp. 2010 Aug 9;(42):1993. doi: 10.3791/1993.

    PMID: 20736913BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Monique Ernst, M.D.

    National Institute of Mental Health (NIMH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2015

First Posted

April 22, 2015

Study Start

April 18, 2015

Primary Completion

October 30, 2018

Study Completion

October 30, 2018

Last Updated

November 4, 2019

Record last verified: 2018-10-30

Locations