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

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ClinicalTrials.gov Identifier: NCT02410954
Recruitment Status : Terminated
First Posted : April 8, 2015
Results First Posted : May 18, 2021
Last Update Posted : May 18, 2021
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Fear Device: NeuroConn Direct Current stimulator Multiple Channel -4 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: Transcranial Direct Current Stimulation (tDCS) as a Treatment for Acute Fear
Study Start Date : December 2015
Actual Primary Completion Date : January 31, 2019
Actual Study Completion Date : January 31, 2019

Arm Intervention/treatment
Experimental: tDCS electrode configuration
Three rounds of tDCS using NeuroConn Direct Current stimulator Multiple Channel -4, Rogue Resolutions treatment optimization where each round includes identifying a promising electrode configuration based on electric field modeling using a realistic head model and capitalizing on the experience with the prior round (for rounds 2 and 3) and testing that electrode placement by administering a series of electrical doses of tDCS with that tDCS electrode configuration (carrying out a dose titration) in a cohort of 10 healthy control subjects to see if we can find an electrical dose which is well-tolerated, safe, suppresses the AOT pupil response and is below recommended current density safety limits (the safety limit in terms of Amperage varies depending on the electrode configuration)
Device: NeuroConn Direct Current stimulator Multiple Channel -4
(tDCS) will be administered with a multichannel tDCS device that can be programmed so that the operator doesn't know the combination of electrodes being used for stimulation, and, thereby allow double-blinding. The active tDCS electrode configuration to be used will be determined with the 3 round iterative procedure described above; based on electric field modeling and personalized electrical dose titration to find the lowest dose that is well-tolerated and engages the target in terms of inhibiting the AOT pupillary response.

Placebo Comparator: Using tDCS to reduce acute fear
Administration of 7.5% CO2 to see if this elicits symptoms of Acute Fear and activates LC and whether tDCS safely inhibits the LC response to 7.5% CO2 compared with sham in a pilot cross-over trial (N=10). A 3-year double-blind, randomized, controlled trial where clinical symptoms of Acute Fear, the primary outcome are elicited with 7.5% CO2 in healthy volunteers is the final study component.
Device: NeuroConn Direct Current stimulator Multiple Channel -4
(tDCS) will be administered with a multichannel tDCS device that can be programmed so that the operator doesn't know the combination of electrodes being used for stimulation, and, thereby allow double-blinding. The active tDCS electrode configuration to be used will be determined with the 3 round iterative procedure described above; based on electric field modeling and personalized electrical dose titration to find the lowest dose that is well-tolerated and engages the target in terms of inhibiting the AOT pupillary response.




Primary Outcome Measures :
  1. Change in VAS-A Rating [ Time Frame: Every 10 min (for approximately 20 minutes) at the end of tDCS/CO2 inhalation following one week post stimulation optimization. ]
    Primary outcome will be the VAS-A "fearful" rating obtained at the end of tDCS/CO2 inhalation. AOT pupil response will be obtained every 10 minutes after the end of the tDCS/CO2 inhalation period to map the duration of persistent effects on LC.



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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02410954


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Andrew Krystal, MD, MS University of California, San Francisco
  Study Documents (Full-Text)

Documents provided by University of California, San Francisco:
Publications:

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02410954    
Other Study ID Numbers: Pro00059590
First Posted: April 8, 2015    Key Record Dates
Results First Posted: May 18, 2021
Last Update Posted: May 18, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No