Investigations of Amygdala Function Using Neurophysiological Recording and Stimulation

PTSD Clinical Trial

Official title:

Investigations of Amygdala Function Using Neurophysiological Recording and Stimulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03958903
• Other study ID #: 42227
• Secondary ID: DP1MH116506FY18
• Status: Completed
• Phase: N/A
• Start date: April 24, 2019
• Est. completion date: March 13, 2020

Study information

• Verified date: September 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to specifically examine the in vivo electrophysiology and effects of direct stimulation of the human amygdala during conditioned and evoked fear. Investigators will also examine amygdala electrophysiology and the effects of stimulation during tasks to examine the effects of reward on fear memory.

This study will recruit subjects with a history of temporal lobe epilepsy (TLE) who have undergone neurosurgical implantation with FDA-approved, NeuroPace RNS devices for treatment of seizures. These patients provide a unique cohort with (Responsive Neurostimulation) RNS devices capable of both recording and stimulating the amygdala during performance of fear-based, behavioral tasks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: March 13, 2020
• Est. primary completion date: March 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• be between age 18-65 years of age

• participants must have received the Neuropace RNS implant to treat their seizures

• have comprehension of instructions in the English language

• be on a stable dose of medications for their epilepsy

• have received the RNS System for Temporal Lobe Epilepsy

• have capacity to provide informed consent

Exclusion Criteria:

• significant cognitive impairment (Mini Mental Status Examination score of less than 20)

• DSM-V diagnosis of alcohol/substance abuse (except nicotine) within the last month or a diagnosis of alcohol/substance dependence (except nicotine) within the last 6 months

• Unable to apply EEG cap

• History of traumatic brain injury

• Active or high suicide risk

• Unable to come to study site/lack of stable housing

• is pregnant or nursing

• Patient's treating neurologist determines that the patient's epilepsy is not stable enough to participate in this study

• Any condition (including psychiatric) which in the judgment of the Investigator would prevent the subject from completion of the study

Related Conditions & MeSH terms

• Fear
• Panic Disorder
• PTSD

Intervention

Device:
• Amygdala recording and stimulation using Neuropace RNS
Subjects will undergo a series of different, fear-related, behavioral tasks while undergoing amygdala electrophysiology recording and stimulation using the Neuropace RNS devices.

Behavioral:
• Behavioral tasks
Subjects perform a set of fear related behavioral tasks over 2 days, with 3 tasks each day.In addition to amygdala RNS recording and stimulation, recording of electroencephalography (EEG), electromyography (EMG), and electrodermal activity (EDA) will be performed using standard techniques to capture and quantify the fear response across all tasks.

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (6)

Clarke HF, Horst NK, Roberts AC. Regional inactivations of primate ventral prefrontal cortex reveal two distinct mechanisms underlying negative bias in decision making. Proc Natl Acad Sci U S A. 2015 Mar 31;112(13):4176-81. doi: 10.1073/pnas.1422440112. Epub 2015 Mar 16. — View Citation

Etkin A, Wager TD. Functional neuroimaging of anxiety: a meta-analysis of emotional processing in PTSD, social anxiety disorder, and specific phobia. Am J Psychiatry. 2007 Oct;164(10):1476-88. doi: 10.1176/appi.ajp.2007.07030504. — View Citation

Gross CT, Canteras NS. The many paths to fear. Nat Rev Neurosci. 2012 Sep;13(9):651-8. doi: 10.1038/nrn3301. Epub 2012 Aug 1. — View Citation

Langevin JP, Koek RJ, Schwartz HN, Chen JWY, Sultzer DL, Mandelkern MA, Kulick AD, Krahl SE. Deep Brain Stimulation of the Basolateral Amygdala for Treatment-Refractory Posttraumatic Stress Disorder. Biol Psychiatry. 2016 May 15;79(10):e82-e84. doi: 10.1016/j.biopsych.2015.09.003. Epub 2015 Sep 11. No abstract available. — View Citation

Morrell MJ, Halpern C. Responsive Direct Brain Stimulation for Epilepsy. Neurosurg Clin N Am. 2016 Jan;27(1):111-21. doi: 10.1016/j.nec.2015.08.012. — View Citation

Sato W, Kochiyama T, Uono S, Matsuda K, Usui K, Inoue Y, Toichi M. Rapid amygdala gamma oscillations in response to fearful facial expressions. Neuropsychologia. 2011 Mar;49(4):612-7. doi: 10.1016/j.neuropsychologia.2010.12.025. Epub 2010 Dec 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EEG(electroencephalography) amplitude changes	Analyze change in amplitude in microvolts -in resting state EEG recording and EEG recording across all the tasks as determined clinically by the Investigator.; Investigators will be analyzing stimulus-induced electrophysiological recordings, focusing on Event-Related Potentials (ERPs).	2 days
Primary	EEG(electroencephalography) frequency changes	Analyze changes in frequency in Hertz- in resting state EEG recording and EEG recording across all the tasks as determined clinically by the Investigator.; Investigators will be analyzing stimulus-induced electrophysiological recordings, focusing on Event-Related Spectral Potentials (ERSP).	2 days
Primary	ECoG (ElectroCorticoGraphy) amplitude changes	Quantify changes in ECoG measures as determined clinically by the Investigator.- using intracranial recordings from the Neuropace devices.; Analyze changes in ECoG amplitude- in resting state and ECoG throughout task and stimulation.	2 days
Primary	ECoG (ElectroCorticoGraphy) frequency changes	Quantify changes in ECoG measures as determined clinically by the Investigator using intracranial recordings from the Neuropace devices.; Analyze changes in ECoG frequency - in resting state and ECoG throughout task and stimulation	2 days
Secondary	Electrophysiological changes in EMG	Analyze changes in amplitude of electromyography (EMG) from resting state to EMG recordings across all tasks.	2 days
Secondary	Electrophysiological changes in EDA	Analyze changes in amplitude of electrodermal activity (EDA) from resting state to EMG recordings across all tasks.	2 days