Fear Clinical Trial
— tDCSOfficial title:
Transcranial Direct Current Stimulation (tDCS) as a Treatment for Acute Fear
Verified date | May 2021 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 14 |
Est. completion date | January 31, 2019 |
Est. primary completion date | January 31, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
United States,
Aston-Jones G, Cohen JD. Adaptive gain and the role of the locus coeruleus-norepinephrine system in optimal performance. J Comp Neurol. 2005 Dec 5;493(1):99-110. Review. — View Citation
Bailey JE, Argyropoulos SV, Kendrick AH, Nutt DJ. Behavioral and cardiovascular effects of 7.5% CO2 in human volunteers. Depress Anxiety. 2005;21(1):18-25. — View Citation
Biancardi V, Bícego KC, Almeida MC, Gargaglioni LH. Locus coeruleus noradrenergic neurons and CO2 drive to breathing. Pflugers Arch. 2008 Mar;455(6):1119-28. Epub 2007 Sep 13. — View Citation
Cuthbert BN, Insel TR. Toward the future of psychiatric diagnosis: the seven pillars of RDoC. BMC Med. 2013 May 14;11:126. doi: 10.1186/1741-7015-11-126. — View Citation
Gilzenrat MS, Nieuwenhuis S, Jepma M, Cohen JD. Pupil diameter tracks changes in control state predicted by the adaptive gain theory of locus coeruleus function. Cogn Affect Behav Neurosci. 2010 May;10(2):252-69. doi: 10.3758/CABN.10.2.252. — View Citation
Insel TR. The NIMH Research Domain Criteria (RDoC) Project: precision medicine for psychiatry. Am J Psychiatry. 2014 Apr;171(4):395-7. doi: 10.1176/appi.ajp.2014.14020138. — View Citation
LeDoux J. Emotional networks and motor control: a fearful view. Prog Brain Res. 1996;107:437-46. Review. — View Citation
Nieuwenhuis S, Aston-Jones G, Cohen JD. Decision making, the P3, and the locus coeruleus-norepinephrine system. Psychol Bull. 2005 Jul;131(4):510-32. Review. — View Citation
Nutt DJ. Altered central alpha 2-adrenoceptor sensitivity in panic disorder. Arch Gen Psychiatry. 1989 Feb;46(2):165-9. — View Citation
Pineda J, Aghajanian GK. Carbon dioxide regulates the tonic activity of locus coeruleus neurons by modulating a proton- and polyamine-sensitive inward rectifier potassium current. Neuroscience. 1997 Apr;77(3):723-43. — View Citation
Redmond DE Jr, Huang YH. Current concepts. II. New evidence for a locus coeruleus-norepinephrine connection with anxiety. Life Sci. 1979 Dec 24;25(26):2149-62. Review. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in VAS-A Rating | 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. | Every 10 min (for approximately 20 minutes) at the end of tDCS/CO2 inhalation following one week post stimulation optimization. |
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