EpilepsyStim_ConNCT05854160
Stimulation-Induced Changes in Fronto-Limbic Network
A study testing Electrical Pulse Train Stimulation in people with Epilepsy and Mental Disorders, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this research is to better understand how emotion processing unfolds in the brain using stereoelectroencephalography (sEEG) and direct brain stimulation. This study will use standard behavioral emotion processing tasks combined with neural recording and direct brain stimulation to assess different… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy, Mental Disorders
- What is being tested?
- Electrical Pulse Train Stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 24 Feb 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) implantation of sEEG electrodes for SOC epilepsy surgery evaluation
- 2) cognitive ability to perform simple tasks and to understand instructions
- 3) implanted electrodes in the amygdala and medial PFC regions
- 4) competency to understand and sign a written informed consent.
Who cannot join
- 1) an inability to complete the task
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Epilepsy Monitoring Unit UAB Hospital
Birmingham, Alabama, 35233
Rebekah Chatfield, BS, (205) 975 3477, Joyb3@uab.edu
Adam Goodman, PhD
About this study
Official title: Stimulation-Induced Changes in Fronto-Limbic Connectivity Control Regulation of the Emotional Response to Threat
The purpose of this research is to better understand how emotion processing unfolds in the brain using stereoelectroencephalography (sEEG) and direct brain stimulation. This study will use standard behavioral emotion processing tasks combined with neural recording and direct brain stimulation to assess different aspects of emotion processing. Stimulation pulses during pre and post-test periods will assess the effects of stimulation before and after conditioning, the results of which will be combined with results from the activity of each electrode during the emotion tasks to inform us of the nature of emotion processing in the brain and allow us to devise brain modulation protocols in the future.
Read the detailed description
About half of the 70M persons with epilepsy (PWE) worldwide will suffer from comorbid mental health disorders (MHDs), with depression and anxiety estimated to be the most prevalent. MHDs and epilepsy each pose significant barriers to work, social functioning, physical disability, and increased risk of mortality. While pathophysiology of epilepsy and anxiety involves similar brain circuits, identifying specific network disruptions that cause emotion regulation dysfunction would critically inform treatment targets for both conditions. Disruptions in the fronto-limbic network (i.e., prefrontal cortex; cingulate cortex; insula; hippocampus; amygdala) are linked to anxiety disorders and impaired emotion response regulation. Likewise, epilepsies are associated with aberrant fronto-limbic function and connectivity that underlie emotion processing. Further, emotion regulation and anxiety symptom severity improve with better seizure control and vice versa. Despite this converging evidence, fronto-limbic circuit disruption that modulates emotion regulation dysfunction in PWE and MHDs remains poorly understood. The goal of the proposed pilot work is to test whether stimulation of specific brain regions modulates the function and connectivity of these networks as well as corresponding regulation of emotional responses. I will achieve the goal of this study by harnessing the novel and innovative approach of stereoelectroencephalography (sEEG) available in UAB's epilepsy monitoring unit as part of standard of care among epilepsy surgery candidates.
Neural recordings that map human brain function underlying behavior and cognition have provided substantial insights into the organization of brain networks and have provided a springboard for launching investigations into developing new interventions. Further, invasive neural recordings in humans provide an unparalleled window into neural circuitry underlying complex moods, emotions, cognition, and behaviors with high spatial and temporal resolution. Assessment of neural circuity underlying these important functions is also critical for the best clinical care of patients undergoing resective surgery to treat epilepsy. In particular, sEEG is a minimally invasive clinical procedure in which electrodes are surgically implanted into the brain in order to better localize the seizure focus. During the post-implantation period, sEEG records directly from an array of depth electrodes implanted throughout the brain to capture spatio-temporal transitions within broadly distributed functional brain networks on a finer neuroanatomical (millimeter) and temporal (millisecond) scale than possible with relatively abundant and standard functional neuroimaging (e.g., fMRI) and electrophysiology techniques (e.g., EEG). Additionally, sEEG provides the ability to stimulate those circuits via the same electrodes by delivering mild intra-cranial electrical stimulations in different brain structures to estimate their impact on cognitive tasks. Thus, sEEG serves as a powerful tool to explore the neural circuitry underlying complex moods, emotions, cognition, and behaviors via non-stimulation recordings for establishing correlations among brain function, connectivity, and behavior, as well as mapping stimulation-manipulated brain-behavior relationships. However, limited applications have been utilized to date for studies of emotion processes. Pavlovian fear conditioning is an effective and widespread paradigm often used in both human and non-human animal models to study emotional learning, memory, and regulation processes. In a typical Pavlovian fear conditioning paradigm, a warning cue, also called a conditioned stimulus (CS+), is paired with a threat (e.g., 100 db static sound, 0.5s), also called an unconditioned stimulus (UCS). A distinct safety cue (CS-) can also be paired with the absence of a threat. After repeated pairings of these stimuli (conditioning trials), only the warning cue begins to produce a conditioned response (CR). The CR is often taken as evidence that the association between the warning cue and threat has been learned. However, learning-related changes in the response to threat, also called the unconditioned response (UCR), are frequently observed. Conditioned diminution of the response to threat is demonstrated by a diminished emotional threat response (e.g., skin conductance) when the threat follows a warning cue (i.e., predictable threat) compared to when a threat follows a safety cue or is presented alone (i.e., unpredictable threat). This conditioned diminution of the threat response provides a continuous measure of the ability to regulate the emotional response to threat. Further, this paradigm has been utilized by our study team to report function and connectivity of the fronto-limbic network correlated with inhibition of emotion responses in healthy controls using fMRI. However, assessing experimenter-induced changes in function, connectivity, and behavior via stimulation of the fronto-limbic brain regions would provide the critical next step of a more rigorous test of the causal hypotheses regarding this brain-behavior relationship.
Temporal lobe epilepsy (TLE) is the most common form of treatment resistant epilepsy. Patients with TLE frequently undergo sEEG evaluation for possible resective surgery and they are an ideal study population to assess brain-behavior relations in emotion processes. TLE is also characterized by a high rate of anxiety disorder comorbidity and is associated with dysfunction within the fronto-limbic circuit underlying emotion processes. The comorbidity between epilepsy and anxiety may arise due to a large degree of overlapping changes within fronto-limbic network that are linked to symptoms of anxiety. Specifically, frontal lobe connectivity with medial temporal regions (i.e., prefrontal cortex; cingulate cortex; hippocampus; amygdala) via the cingulum bundle is an important network involved in seizure propagation and TLE comorbidities, including anxiety disorders. Likewise, neuroimaging studies (i.e., fMRI) have demonstrated correlations between emotion regulation and function within this fronto-limbic network. Yet, existing neuroimaging and electrophysiology techniques are limited in their assessment of experimenter-manipulated brain-behavior relationships due to correlational approaches, in addition to poor temporal resolution (1-3 s TR in fMRI) and spatial specificity (broad cortical assessment in EEG). Thus, fronto-limbic sEEG mapping will serve as a valuable assessment of function and connectivity modulating inhibition of emotion responses before and after Pavlovian fear conditioning. By also conducting mental health assessments in these patients, this project will serve as a valuable model for better understanding network function linked to epilepsy, anxiety, and healthy emotion processes.
- Conditions
- Epilepsy, Mental Disorders
- Being tested
- Electrical Pulse Train Stimulation
- Keywords
- epilepsy, comorbid mental health disorders, sEEG, Anxiety, Fronto-limbic network, Pavlovian fear conditioning paradigm
- Medical subject headings
- Epilepsy, Mental Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical Pulse Train StimulationProcedure or surgery
sEEG provides the ability to stimulate neural circuits via implanted electrodes by delivering mild intra-cranial electrical stimulations in different brain structures to estimate their impact on cognitive tasks.
| Study group | Role | What they receive |
|---|---|---|
| Acquisition Stimulation Test | Experimental | Single pulse stimulation will be delivered and measured prior to the rating task. Next, subjects perform the Pavlovian fear conditioning paradigm. Participants will be asked to perform a rating task automated on a PC where they continuously update a rating bar using the touchpad to indicate their confidence that a static sound is about to occur on a moment-by-moment basis (0-not confident to 100-very confident). For the stimulation experiment, research staff will explain that electrical stimulation will be applied before the rating task, in isolation, as well as on some trials at controlled time points while the patient performs the rating task Receives: Procedure: Electrical Pulse Train Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fronto-limbic connectivity and autonomic or expectation responses
We will test for a positive linear relationship (Pearson r correlation test) between dmPFC to amygdala connectivity values (Granger causality coefficient; sEEG) and physiologic (Skin conductance beta estimates; finger electrodes) and cognitive (self-report; expectancy) threat regulation measures.
Measured: 20 Minutes
Fronto-limbic connectivity strength relation to anxiety symptom severity by conducting between-subjects group-level comparisons
We will test for a positive linear relationship (Pearson r test) between dmPFC to amygdala effective connectivity values (Granger causality coefficient; sEEG) and measures of anxiety symptom severity (Self-report; Beck Anxiety Inventory [BAI])
Measured: 20 Minutes
Anticipatory fronto-limbic connectivity exerting a causal effect on regulation of predictable threat responses using within-subjects group-level comparisons.
We will test for an effect of stimulation pulse trains (2-sec; sEEG) delivered to the dmPFC by using four (Pre-acquisition stimulation, Pre-acquisition sham, Post-acquisition stimulation, Post-acquisition sham) repeated samples t-tests comparing the factor of Condition (Cue+Threat vs Threat-Alone) on amygdala responses (gamma band power changes; sEEG).
Measured: 20 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start1 Mar 2023
- Primary completion28 Feb 2026
- Study completion24 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Adam Goodman, University of Alabama at Birmingham
- Investigators
- Adam Goodman, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05854160
- Sponsor's protocol ID
- IRB-300009434
- Other IDs
- 1R21MH133055-01
- Acronym
- Stim_Con
- Status last verified
- Feb 2026
- First submitted
- 20 Apr 2023
- Last updated
- 23 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: NIMH Data Archive (NDA)
Publications
Goodman AM, Harnett NG, Knight DC. Pavlovian conditioned diminution of the neurobehavioral response to threat. Neurosci Biobehav Rev. 2018 Jan;84:218-224. doi: 10.1016/j.neubiorev.2017.11.021. Epub 2017 Dec 2.
PubMed 29203422Goodman AM, Wheelock MD, Harnett NG, Davis ES, Mrug S, Deshpande G, Knight DC. Stress-Induced Changes in Effective Connectivity During Regulation of the Emotional Response to Threat. Brain Connect. 2022 Sep;12(7):629-638. doi: 10.1089/brain.2021.0062. Epub 2021 Dec 31.
PubMed 34541896
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stimulation-Induced Changes in Fronto-Limbic Connectivity Control Regulation of the Emotional Response to Threat
- ClinicalTrials.gov ID
- NCT05854160
- Acronym / sponsor ID
- Stim_Con / IRB-300009434
- Conditions
- Epilepsy, Mental Disorders
- Keywords
- epilepsy, comorbid mental health disorders, sEEG, Anxiety, Fronto-limbic network, Pavlovian fear conditioning paradigm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 24 Feb 2027 (estimated)
- First posted
- 11 May 2023 (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.
The purpose of this research is to better understand how emotion processing unfolds in the brain using stereoelectroencephalography (sEEG) and direct brain stimulation. This study will use standard behavioral emotion processing tasks combined with neural recording and direct brain stimulation to assess different aspects of emotion processing. Stimulation pulses during pre and post-test periods will assess the effects of stimulation before and after conditioning, the results of which will be combined with results from the activity of each electrode during the emotion tasks to inform us of the nature of emotion processing in the brain and allow us to devise brain modulation protocols in the future.
Detailed description
About half of the 70M persons with epilepsy (PWE) worldwide will suffer from comorbid mental health disorders (MHDs), with depression and anxiety estimated to be the most prevalent. MHDs and epilepsy each pose significant barriers to work, social functioning, physical disability, and increased risk of mortality. While pathophysiology of epilepsy and anxiety involves similar brain circuits, identifying specific network disruptions that cause emotion regulation dysfunction would critically inform treatment targets for both conditions. Disruptions in the fronto-limbic network (i.e., prefrontal cortex; cingulate cortex; insula; hippocampus; amygdala) are linked to anxiety disorders and impaired emotion response regulation. Likewise, epilepsies are associated with aberrant fronto-limbic function and connectivity that underlie emotion processing. Further, emotion regulation and anxiety symptom severity improve with better seizure control and vice versa. Despite this converging evidence, fronto-limbic circuit disruption that modulates emotion regulation dysfunction in PWE and MHDs remains poorly understood. The goal of the proposed pilot work is to test whether stimulation of specific brain regions modulates the function and connectivity of these networks as well as corresponding regulation of emotional responses. I will achieve the goal of this study by harnessing the novel and innovative approach of stereoelectroencephalography (sEEG) available in UAB's epilepsy monitoring unit as part of standard of care among epilepsy surgery candidates.
Neural recordings that map human brain function underlying behavior and cognition have provided substantial insights into the organization of brain networks and have provided a springboard for launching investigations into developing new interventions. Further, invasive neural recordings in humans provide an unparalleled window into neural circuitry underlying complex moods, emotions, cognition, and behaviors with high spatial and temporal resolution. Assessment of neural circuity underlying these important functions is also critical for the best clinical care of patients undergoing resective surgery to treat epilepsy. In particular, sEEG is a minimally invasive clinical procedure in which electrodes are surgically implanted into the brain in order to better localize the seizure focus. During the post-implantation period, sEEG records directly from an array of depth electrodes implanted throughout the brain to capture spatio-temporal transitions within broadly distributed functional brain networks on a finer neuroanatomical (millimeter) and temporal (millisecond) scale than possible with relatively abundant and standard functional neuroimaging (e.g., fMRI) and electrophysiology techniques (e.g., EEG). Additionally, sEEG provides the ability to stimulate those circuits via the same electrodes by delivering mild intra-cranial electrical stimulations in different brain structures to estimate their impact on cognitive tasks. Thus, sEEG serves as a powerful tool to explore the neural circuitry underlying complex moods, emotions, cognition, and behaviors via non-stimulation recordings for establishing correlations among brain function, connectivity, and behavior, as well as mapping stimulation-manipulated brain-behavior relationships. However, limited applications have been utilized to date for studies of emotion processes. Pavlovian fear conditioning is an effective and widespread paradigm often used in both human and non-human animal models to study emotional learning, memory, and regulation processes. In a typical Pavlovian fear conditioning paradigm, a warning cue, also called a conditioned stimulus (CS+), is paired with a threat (e.g., 100 db static sound, 0.5s), also called an unconditioned stimulus (UCS). A distinct safety cue (CS-) can also be paired with the absence of a threat. After repeated pairings of these stimuli (conditioning trials), only the warning cue begins to produce a conditioned response (CR). The CR is often taken as evidence that the association between the warning cue and threat has been learned. However, learning-related changes in the response to threat, also called the unconditioned response (UCR), are frequently observed. Conditioned diminution of the response to threat is demonstrated by a diminished emotional threat response (e.g., skin conductance) when the threat follows a warning cue (i.e., predictable threat) compared to when a threat follows a safety cue or is presented alone (i.e., unpredictable threat). This conditioned diminution of the threat response provides a continuous measure of the ability to regulate the emotional response to threat. Further, this paradigm has been utilized by our study team to report function and connectivity of the fronto-limbic network correlated with inhibition of emotion responses in healthy controls using fMRI. However, assessing experimenter-induced changes in function, connectivity, and behavior via stimulation of the fronto-limbic brain regions would provide the critical next step of a more rigorous test of the causal hypotheses regarding this brain-behavior relationship.
Temporal lobe epilepsy (TLE) is the most common form of treatment resistant epilepsy. Patients with TLE frequently undergo sEEG evaluation for possible resective surgery and they are an ideal study population to assess brain-behavior relations in emotion processes. TLE is also characterized by a high rate of anxiety disorder comorbidity and is associated with dysfunction within the fronto-limbic circuit underlying emotion processes. The comorbidity between epilepsy and anxiety may arise due to a large degree of overlapping changes within fronto-limbic network that are linked to symptoms of anxiety. Specifically, frontal lobe connectivity with medial temporal regions (i.e., prefrontal cortex; cingulate cortex; hippocampus; amygdala) via the cingulum bundle is an important network involved in seizure propagation and TLE comorbidities, including anxiety disorders. Likewise, neuroimaging studies (i.e., fMRI) have demonstrated correlations between emotion regulation and function within this fronto-limbic network. Yet, existing neuroimaging and electrophysiology techniques are limited in their assessment of experimenter-manipulated brain-behavior relationships due to correlational approaches, in addition to poor temporal resolution (1-3 s TR in fMRI) and spatial specificity (broad cortical assessment in EEG). Thus, fronto-limbic sEEG mapping will serve as a valuable assessment of function and connectivity modulating inhibition of emotion responses before and after Pavlovian fear conditioning. By also conducting mental health assessments in these patients, this project will serve as a valuable model for better understanding network function linked to epilepsy, anxiety, and healthy emotion processes.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acquisition Stimulation Test | Experimental | Procedure: Electrical Pulse Train StimulationSingle pulse stimulation will be delivered and measured prior to the rating task. Next, subjects perform the Pavlovian fear conditioning paradigm. Participants will be asked to perform a rating task automated on a PC where they continuously update a rating bar using the touchpad to indicate their confidence that a static sound is about to occur on a moment-by-moment basis (0-not confident to 100-very confident). For the stimulation experiment, research staff will explain that electrical stimulation will be applied before the rating task, in isolation, as well as on some trials at controlled time points while the patient performs the rating task |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1) implantation of sEEG electrodes for SOC epilepsy surgery evaluation
- 2) cognitive ability to perform simple tasks and to understand instructions
- 3) implanted electrodes in the amygdala and medial PFC regions
- 4) competency to understand and sign a written informed consent.
Key exclusion criteria (1 listed)
- 1) an inability to complete the task
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 |
|---|---|---|
| Electrical Pulse Train StimulationsEEG provides the ability to stimulate neural circuits via implanted electrodes by delivering mild intra-cranial electrical stimulations in different brain structures to estimate their impact on cognitive tasks. | Procedure or surgery | Acquisition Stimulation Test |
Primary outcome
Fronto-limbic connectivity and autonomic or expectation responses
Time frame: 20 Minutes
We will test for a positive linear relationship (Pearson r correlation test) between dmPFC to amygdala connectivity values (Granger causality coefficient; sEEG) and physiologic (Skin conductance beta estimates; finger electrodes) and cognitive (self-report; expectancy) threat regulation measures.
Fronto-limbic connectivity strength relation to anxiety symptom severity by conducting between-subjects group-level comparisons
Time frame: 20 Minutes
We will test for a positive linear relationship (Pearson r test) between dmPFC to amygdala effective connectivity values (Granger causality coefficient; sEEG) and measures of anxiety symptom severity (Self-report; Beck Anxiety Inventory [BAI])
Anticipatory fronto-limbic connectivity exerting a causal effect on regulation of predictable threat responses using within-subjects group-level comparisons.
Time frame: 20 Minutes
We will test for an effect of stimulation pulse trains (2-sec; sEEG) delivered to the dmPFC by using four (Pre-acquisition stimulation, Pre-acquisition sham, Post-acquisition stimulation, Post-acquisition sham) repeated samples t-tests comparing the factor of Condition (Cue+Threat vs Threat-Alone) on amygdala responses (gamma band power changes; sEEG).
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 23 Jun 2026.
- Background: PubMed 29203422Goodman AM, Harnett NG, Knight DC. Pavlovian conditioned diminution of the neurobehavioral response to threat. Neurosci Biobehav Rev. 2018 Jan;84:218-224. doi: 10.1016/j.neubiorev.2017.11.021. Epub 2017 Dec 2.
- Background: PubMed 34541896Goodman AM, Wheelock MD, Harnett NG, Davis ES, Mrug S, Deshpande G, Knight DC. Stress-Induced Changes in Effective Connectivity During Regulation of the Emotional Response to Threat. Brain Connect. 2022 Sep;12(7):629-638. doi: 10.1089/brain.2021.0062. Epub 2021 Dec 31.
- Individual participant dataSharing planned: Yes. NIMH Data Archive (NDA)
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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.
Adam Goodman, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical Pulse Train Stimulation in people with Epilepsy and Mental Disorders, run by University of Alabama at Birmingham 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 4 inclusion and 1 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 23 Jun 2026. 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?
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 Rebekah Chatfield, BS ((205) 975-3477, joyb3@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fronto-limbic connectivity and autonomic or expectation responses (time frame: 20 Minutes). The study lists 3 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 NCT05854160, which also lists 2 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 23 Jun 2026.