Transcranial Direct Current Stimulation (tDCS) as a Treatment for Acute Fear

Stopped early · Not applicable

Conditions studied: Fear

In brief

Locus coeruleus (LC) norepinephrine (NE) neuron activity has been convincingly linked to regulation of acute fear. This study will address whether LC NE activity examined through pupil measures will reflect carbon dioxide (CO2) induced fear-responses in humans and if transcranial direct current stimulation (tDCS) can mitigate these effects. A 2 year R21 phase establishing feasibility, tolerability, safety, and proof-of-concept (POC) in terms of capacity to engage LC NE neurons with tDCS, followed by a 3 year R33 parallel-group, double-blind, randomized, controlled trial will determine the degree to which engaging LC NE neurons with tDCS improves clinical symptoms.

Key facts

Study ID

NCT02410954

Run by

University of California, San Francisco

People needed

14

Starts

2015-12-01

Expected to finish

2019-01-31

Last updated by the study team

2021-05-18

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Use of effective method of birth control for women of childbearing capacity
• Willing and able to provide informed consent
• Have a significant difference between the mean pupil diameter in response to odd and common tones in the AOT during screening
• The10 subjects in the R21 cross-over study and all of the R33 subjects must have a 26% increase in VAS-A "fearful" response to 7.5% CO2 at the first CO2 challenge session
• Able to follow study procedures.

You may not qualify if…

• Current or past Axis I Diagnostic and Statistical Manual (DSM-IV) disorder based on the MINI
• Current or past history of substance abuse or dependence (excluding nicotine) based on history or positive urine toxicology
• Current unstable medical condition
• Any current neurological condition or medical condition that is known to affect pupillary function, mood/anxiety, or neurologic function generally
• Pregnancy based on Urine Pregnancy Test
• Women who are breast-feeding
• Use of medications known to affect Central Nervous System (CNS) function within 5 half-lives screening
• Use of a pacemaker

Where it is running

• University of California, San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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