FearNCT03958903
Investigations of Amygdala Function Using Neurophysiological Recording and Stimulation
A study testing Amygdala recording and stimulation using Neuropace RNS and Behavioral tasks in people with Fear and PTSD, run by Stanford University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fear, PTSD, Panic Disorder
- What is being tested?
- Amygdala recording and stimulation using Neuropace RNS and Behavioral tasks
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2019to 13 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Fear, PTSD, Panic Disorder
- Being tested
- Amygdala recording and stimulation using Neuropace RNS, Behavioral tasks
- Keywords
- Responsive neurostimulation, Amygdala electrophysiology, Neuropace RNS, Temporal lobe epilepsy, closed-loop brain stimulation
- Medical subject headings
- Stress Disorders, Post-Traumatic, Panic Disorder, Epilepsy, Temporal Lobe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amygdala recording and stimulation using Neuropace RNSDevice
Subjects will undergo a series of different, fear-related, behavioral tasks while undergoing amygdala electrophysiology recording and stimulation using the Neuropace RNS devices.
Behavioral tasksBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Neurophysiological recording and stimulation of amygdala | Experimental | Recording and stimulation of amygdala using Neuropace RNS devices at certain points through out the behavioral tasks. Receives: Device: Amygdala recording and stimulation using Neuropace RNS; Behavioral: Behavioral tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 days
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).
Measured: 2 days
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.
Measured: 2 days
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
Measured: 2 days
Secondary outcomes (2)
Electrophysiological changes in EMG
Analyze changes in amplitude of electromyography (EMG) from resting state to EMG recordings across all tasks.
Measured: 2 days
Electrophysiological changes in EDA
Analyze changes in amplitude of electrodermal activity (EDA) from resting state to EMG recordings across all tasks.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start24 Apr 2019
- Primary completion13 Mar 2020
- Study completion13 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for FearStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Mahendra Bhati, Stanford University
- Investigators
- Mahendra Bhati, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03958903
- Sponsor's protocol ID
- 42227
- Other IDs
- DP1MH116506, FY18 small grant fund award
- Status last verified
- Sep 2023
- First submitted
- 20 May 2019
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22850830Etkin 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.
PubMed 17898336Morrell 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.
PubMed 26615113Sato 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.
PubMed 21182851Langevin 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.
PubMed 26475671Clarke 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.
PubMed 25775597
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigations of Amygdala Function Using Neurophysiological Recording and Stimulation
- ClinicalTrials.gov ID
- NCT03958903
- Acronym / sponsor ID
- 42227
- Conditions
- Fear, PTSD, Panic Disorder
- Keywords
- Responsive neurostimulation, Amygdala electrophysiology, Neuropace RNS, Temporal lobe epilepsy, closed-loop brain stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 24 Apr 2019 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 22 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurophysiological recording and stimulation of amygdala | Experimental | Device: Amygdala recording and stimulation using Neuropace RNS, Behavioral: Behavioral tasksRecording and stimulation of amygdala using Neuropace RNS devices at certain points through out the behavioral tasks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amygdala recording and stimulation using Neuropace RNSSubjects will undergo a series of different, fear-related, behavioral tasks while undergoing amygdala electrophysiology recording and stimulation using the Neuropace RNS devices. | Device | Neurophysiological recording and stimulation of amygdala |
| Behavioral tasksSubjects 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. | Behavioural | Neurophysiological recording and stimulation of amygdala |
Primary outcome
EEG(electroencephalography) amplitude changes
Time frame: 2 days
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).
EEG(electroencephalography) frequency changes
Time frame: 2 days
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).
ECoG (ElectroCorticoGraphy) amplitude changes
Time frame: 2 days
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.
ECoG (ElectroCorticoGraphy) frequency changes
Time frame: 2 days
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 secondary outcomes
Electrophysiological changes in EMG
Time frame: 2 days
Electrophysiological changes in EDA
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Background: PubMed 22850830Gross 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.
- Background: PubMed 17898336Etkin 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.
- Background: PubMed 26615113Morrell 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.
- Background: PubMed 21182851Sato 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.
- Background: PubMed 26475671Langevin 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.
- Background: PubMed 25775597Clarke 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahendra Bhati, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amygdala recording and stimulation using Neuropace RNS and Behavioral tasks in people with Fear and PTSD, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG(electroencephalography) amplitude changes (time frame: 2 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03958903, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.