FearNCT05120635
Intracranial Neurophysiological Signatures of Fear and Anxiety in Humans
A study testing Deep Brain Stimulation and Virtual and augmented reality tasks in people with Fear and GAD, run by Duke University at 2 sites in United States.
Trial summary
Anxiety disorders such as post-traumatic stress disorder (PTSD) and generalized anxiety disorder (GAD) affect a large number of individuals with a significant portion of patients failing to improve with current treatments. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Fear, GAD, Emotional Memory
- What is being tested?
- Deep Brain Stimulation and Virtual and augmented reality tasks
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2021to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Has undergone acute depth or chronic responsive neurostimulation (RNS) electrode placement
- Willing to provide informed consent and participate in the study
- Ability to read and write English fluently
Who cannot join
- Unwilling to provide informed consent
- Has not undergone acute depth or chronic responsive neurostimulation (RNS) electrode placement
- Pregnant women
- Participants with active psychosis
- Participants with suicidal ideation
- Participants with substance abuse issues
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Duke University Health System
Durham, North Carolina, 27705
Gabriela Vilchez, 9196812577, suthanalab@duke.edu
Nanthia Suthana, PhD
- Recruiting
University of California Los Angeles
Los Angeles, California, 90024
Sonja Hiller, 9196812577, suthanalab@mednet.ucla.edu
About this study
Anxiety disorders such as post-traumatic stress disorder (PTSD) and generalized anxiety disorder (GAD) affect a large number of individuals with a significant portion of patients failing to improve with current treatments.
The purpose of this study is to understand the brain mechanisms that produce fear and anxiety in humans. To accomplish this goal, we will measure the brain activity along with the heart rate and skin perspiration of patients while they are completing tasks on a computer. Some of the tasks will also use a virtual reality headset and transport the patient in a video game-like environment. These tasks will expose the participants to various levels of fear-provoking images. Participants with responsive neurostimulation (RNS) implants will be enrolled under Pro00117931 at Duke, but their results for fear and anxiety tasks will be reported under NCT05120635.
- Conditions
- Fear, GAD, Emotional Memory, PTSD
- Being tested
- Deep Brain Stimulation, Virtual and augmented reality tasks
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain StimulationDevice
Deep brain stimulation will be used
Virtual and augmented reality tasksBehavioural
Virtual and augmented reality tasks will be used.
| Study group | Role | What they receive |
|---|---|---|
| EMU Participants | Other | Subjects participating in the study at the Epilepsy Monitoring Unity (EMU). Receives: Device: Deep Brain Stimulation; Behavioral: Virtual and augmented reality tasks |
| RNS Participants | Other | Subjects with RNS implants. Receives: Device: Deep Brain Stimulation; Behavioral: Virtual and augmented reality tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiological change - eye-blinks
Eye blinks will be measured using an eye tracking device and will be measure in blinks per second.
Measured: during the intervention/behavioral tasks with and without stimulation
Physiological change - heart rate variability
heart rate variability will be measured in milliseconds.
Measured: during the intervention/behavioral tasks with and without stimulation
Physiological change - skin conductance
Skin conductance will be measured in microSiemens.
Measured: during the intervention/behavioral tasks with and without stimulation
Neurophysiological activity
Neurophysiological activity will be measured in Hz
Measured: during the intervention/behavioral tasks with and without stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start1 Oct 2021
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FearStudies of the same condition, open and under way.
- More trials run by Duke 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
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), VA Greater Los Angeles Healthcare System, NeuroPace, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Nanthia Suthana, PhD, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05120635
- Sponsor's protocol ID
- PRO00118015
- Other IDs
- R01MH124761, Pro00117931
- Status last verified
- Aug 2026
- First submitted
- 4 Oct 2021
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracranial Neurophysiological Signatures of Fear and Anxiety in Humans
- ClinicalTrials.gov ID
- NCT05120635
- Acronym / sponsor ID
- PRO00118015
- Conditions
- Fear, GAD, Emotional Memory, PTSD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), VA Greater Los Angeles Healthcare System, NeuroPace, National Institute of Mental Health (NIMH)
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 15 Nov 2021 (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.
Anxiety disorders such as post-traumatic stress disorder (PTSD) and generalized anxiety disorder (GAD) affect a large number of individuals with a significant portion of patients failing to improve with current treatments.
The purpose of this study is to understand the brain mechanisms that produce fear and anxiety in humans. To accomplish this goal, we will measure the brain activity along with the heart rate and skin perspiration of patients while they are completing tasks on a computer. Some of the tasks will also use a virtual reality headset and transport the patient in a video game-like environment. These tasks will expose the participants to various levels of fear-provoking images. Participants with responsive neurostimulation (RNS) implants will be enrolled under Pro00117931 at Duke, but their results for fear and anxiety tasks will be reported under NCT05120635.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMU Participants | Other | Device: Deep Brain Stimulation, Behavioral: Virtual and augmented reality tasksSubjects participating in the study at the Epilepsy Monitoring Unity (EMU). |
| RNS Participants | Other | Device: Deep Brain Stimulation, Behavioral: Virtual and augmented reality tasksSubjects with RNS implants. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- Has undergone acute depth or chronic responsive neurostimulation (RNS) electrode placement
- Willing to provide informed consent and participate in the study
- Ability to read and write English fluently
Key exclusion criteria (6 listed)
- Unwilling to provide informed consent
- Has not undergone acute depth or chronic responsive neurostimulation (RNS) electrode placement
- Pregnant women
- Participants with active psychosis
- Participants with suicidal ideation
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 |
|---|---|---|
| Deep Brain StimulationDeep brain stimulation will be used | Device | EMU Participants, RNS Participants |
| Virtual and augmented reality tasksVirtual and augmented reality tasks will be used. | Behavioural | EMU Participants, RNS Participants |
Primary outcome
Physiological change - eye-blinks
Time frame: during the intervention/behavioral tasks with and without stimulation
Eye blinks will be measured using an eye tracking device and will be measure in blinks per second.
Physiological change - heart rate variability
Time frame: during the intervention/behavioral tasks with and without stimulation
heart rate variability will be measured in milliseconds.
Physiological change - skin conductance
Time frame: during the intervention/behavioral tasks with and without stimulation
Skin conductance will be measured in microSiemens.
Neurophysiological activity
Time frame: during the intervention/behavioral tasks with and without stimulation
Neurophysiological activity will be measured in Hz
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Fear
RecruitingObservational study
Lived Experiences of Women Diagnosed With HPV Infection
Human Papillomavirus Infection
Recruiting
Effects of Virtual Reality Environments on Walking in Adults With and Without Knee Osteoarthritis
Knee Osteoarthritis
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
An Innovative Cognitive-Behavioral Treatment For Chronic Orofacial Pain
Chronic Primary Orofacial Pain (CPOP), Persistent Idiopathic Facial Pain (PIFP)
Not yet recruiting
Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
Chronic Pain, Musculoskeletal Pain
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.
Nanthia Suthana, PhD principal investigator
Duke Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Brain Stimulation and Virtual and augmented reality tasks in people with Fear and GAD, run by Duke University at 2 sites 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aaron Halvorsen, PhD (9196812577, suthanalab@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiological change - eye-blinks (time frame: during the intervention/behavioral tasks with and without stimulation). 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?
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 31 Aug 2026.