Refractory EpilepsyNCT05292183
Modulation of Emotion Perception in Humans Via Amygdala Stimulation
A study testing Electrical Stimulation in people with Refractory Epilepsy, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
This study will enroll patients with epilepsy who are being evaluated for epilepsy surgery and have intracranial EEG electrodes. In this study, the aim is to record brain signals from areas important in social and emotional processing and to understand how electrical brain stimulation - called neuromodulation … Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Epilepsy
- What is being tested?
- Electrical Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2022to 16 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age of 18 years or older
- FSIQ 75 and above or any equivalent test of generalized intelligence as determined by the PI to adequately predict engagement in the task
- Able to give independent consent for participation in the study
Who cannot join
- Additional neurological disorders (such as dementia, stroke, brain tumor, etc.)
- Any psychiatric condition that would limit their ability to provide consent and/or perform study tasks within normal limits. This would be based on presurgical psychiatric assessment.
- Anything else, that in the opinion of the principal investigator, might preclude them from participating in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03776
About this study
Official title: Neuromodulation of Affective Valence in Humans by Amygdala Stimulation
This study will enroll patients with epilepsy who are being evaluated for epilepsy surgery and have intracranial EEG electrodes. In this study, the aim is to record brain signals from areas important in social and emotional processing and to understand how electrical brain stimulation - called neuromodulation - affects such processing. Patients enrolled in this study will be asked to view images depicting a variety of emotionally positive, negative, or neutral themes. As the patient views these images, a small amount of imperceptible and painless electric current will be used to map function of certain parts of a human brain. The overarching goal of the study is to determine if neuromodulation can be used in certain areas of the brain to treat cognitive disorders such as memory loss and post-traumatic stress disorder.
Read the detailed description
One to two study tasks will be performed by each participant to help us understand how the brain processes emotion and how stimulation effects emotional processing.
These study tasks will last up to several minutes each, and generally require participants to view pictures while EEG recordings are made from the electrodes placed in specific areas of the brain. The routine video/EEG monitoring and brain function testing should not be disrupted or prolonged by the study testing, and if a participant has a seizure during the testing, it will be recorded as usual for review by participant's providers.
The following study procedures will likely be carried out in each individual case:
- Recording from areas important in social and emotional processing. A computer monitor will be used to present pictures of people engaged in social interaction. Additionally, the researchers will present individual participants with well standardized tasks designed to understand the nature of emotions. Some of these images may be emotionally disturbing. Should participants become uncomfortable with viewing such images, participants would be provided with a choice to not participate in this study.
- Using brain stimulation to map function of certain parts of your brain. A brain stimulator will be used -normally used to map where important brain regions are located-to understand new functions of the brain. Each participant will be presented with pictures on a computer screen. As participant(s) views these pictures, the brain stimulator may be activated (this is not something that is felt by a person) and an electrical stimulation through the implanted electrodes will be delivered to specific regions of the brain. Research team will be measuring how brain stimulation may affect each individual's emotional response to a specific stimulus.
- Completing the Emotion Self-Rating (ESR) Scale.
This questionnaire will be given to ensure the stimulation doesn't increase any unpleasant emotional experience for participants. This will take place before and during the stimulation of a specific part of the brain.
- Conditions
- Refractory Epilepsy
- Being tested
- Electrical Stimulation
- Keywords
- Human Amygdala, Deep Brain Stimulation, Psychiatric Disorders
- Medical subject headings
- Drug Resistant Epilepsy, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical StimulationOther
We will use a computer randomized stimulation of specific areas in the amygdala while showing a computer randomized set of pictures.
| Study group | Role | What they receive |
|---|---|---|
| Stimulation | Experimental | This part will include 24 randomly chosen images from each of four categories (total of 96 images varying in valence and arousal) and will be presented block-randomized amygdala stimulation. Receives: Other: Electrical Stimulation |
| No stimulation | No intervention | This part will include 24 randomly chosen images from each of four categories (total of 96 images varying in valence and arousal) and will be presented without amygdala stimulation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Z-score Gamma Power in Amygdala Per Valence Category
Valence of each image is assessed by each subject using a Likert-type rating scale with a range of 1 to 7, where 1 represents most negative valence, 4 as neutral, and 7 as most positive. Valence categories are defined in the following manner: negative = 1.0 to 3.0, neutral = 3.1 to 5.0, negative = 5.1 to 7.0. Activation is measured by gamma frequency power (mµV²/30-100 Hz) at 0-1000 msec following image presentation in the basolateral amygdala electrode contact and compared to baseline defined as -500 msec to 0 of image presentation. Gamma power is transformed to z-score (baseline to following image presentation) for individual observations. Z-score of 0 indicates no change from baseline. Positive z-score indicates activation of the basolateral amygdala compared to baseline. Gamma frequency range is defined as 30-100 Hz in intracranial EEG. Power was estimated via a multitaper time-frequency transformation approach. Statistics was done using linear-mixed effects models (LMEs).
Measured: 0 to 1000 MS following image presentation
Effect of Amygdala Stimulation on Perception of Valence
Here we assess the effect of basolateral amygdala stimulation on valence ratings. Participants rate the emotional valence of each image in a Likert scale range of 1-7 (1= maximum negative valence, 4=maximum neutral valence, and 7 maximum positive valence) for each of the 96 images. We randomly apply electrical stimulation during perception and of 50% of the images presented. We analyze the effect of stimulation on image rating in the following manner: we grouped the images into three categories, negative (1 to 3), neutral (3.1 to 5), and positive (5.1 to 7) based on subject specific ratings. 2. We then used a multivariate model to assess the effect of stimulation on perception of neutral, negative, and positive categories across 9 patients.
Measured: Valence ratings were assessed immediately following the viewing of each image during performance of the task.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start31 Mar 2022
- Primary completion16 Feb 2024
- Study completion16 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Refractory EpilepsyStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe 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
- Randomised
- Intervention model
- Single group
- Model description
- The researchers will use computerized randomization of electrical stimulation for each participant. The stimulation vs non stimulation are not discrete events and occur in random order within individual participants during each daily testing session.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Krzysztof Bujarski, Dartmouth-Hitchcock Medical Center
- Investigators
- Krzysztof A Bujarski, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05292183
- Sponsor's protocol ID
- STUDY02001399
- Other IDs
- 1R21MH124674-01A1
- Status last verified
- Sep 2025
- First submitted
- 14 Mar 2022
- Last updated
- 22 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study results will be available on ClinicalTrials.gov and will be published in appropriate clinical journal upon completion.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation of Affective Valence in Humans by Amygdala Stimulation
- ClinicalTrials.gov ID
- NCT05292183
- Acronym / sponsor ID
- STUDY02001399
- Conditions
- Refractory Epilepsy
- Keywords
- Human Amygdala, Deep Brain Stimulation, Psychiatric Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 16 Feb 2024 (actual)
- Study completion
- 16 Feb 2024 (actual)
- First posted
- 23 Mar 2022 (actual)
- Results
- Posted 22 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will enroll patients with epilepsy who are being evaluated for epilepsy surgery and have intracranial EEG electrodes. In this study, the aim is to record brain signals from areas important in social and emotional processing and to understand how electrical brain stimulation - called neuromodulation - affects such processing. Patients enrolled in this study will be asked to view images depicting a variety of emotionally positive, negative, or neutral themes. As the patient views these images, a small amount of imperceptible and painless electric current will be used to map function of certain parts of a human brain. The overarching goal of the study is to determine if neuromodulation can be used in certain areas of the brain to treat cognitive disorders such as memory loss and post-traumatic stress disorder.
Detailed description
One to two study tasks will be performed by each participant to help us understand how the brain processes emotion and how stimulation effects emotional processing.
These study tasks will last up to several minutes each, and generally require participants to view pictures while EEG recordings are made from the electrodes placed in specific areas of the brain. The routine video/EEG monitoring and brain function testing should not be disrupted or prolonged by the study testing, and if a participant has a seizure during the testing, it will be recorded as usual for review by participant's providers.
The following study procedures will likely be carried out in each individual case:
- Recording from areas important in social and emotional processing. A computer monitor will be used to present pictures of people engaged in social interaction. Additionally, the researchers will present individual participants with well standardized tasks designed to understand the nature of emotions. Some of these images may be emotionally disturbing. Should participants become uncomfortable with viewing such images, participants would be provided with a choice to not participate in this study.
- Using brain stimulation to map function of certain parts of your brain. A brain stimulator will be used -normally used to map where important brain regions are located-to understand new functions of the brain. Each participant will be presented with pictures on a computer screen. As participant(s) views these pictures, the brain stimulator may be activated (this is not something that is felt by a person) and an electrical stimulation through the implanted electrodes will be delivered to specific regions of the brain. Research team will be measuring how brain stimulation may affect each individual's emotional response to a specific stimulus.
- Completing the Emotion Self-Rating (ESR) Scale.
This questionnaire will be given to ensure the stimulation doesn't increase any unpleasant emotional experience for participants. This will take place before and during the stimulation of a specific part of the brain.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The researchers will use computerized randomization of electrical stimulation for each participant. The stimulation vs non stimulation are not discrete events and occur in random order within individual participants during each daily testing session.
| Arm | Type | Receives |
|---|---|---|
| Stimulation | Experimental | Other: Electrical StimulationThis part will include 24 randomly chosen images from each of four categories (total of 96 images varying in valence and arousal) and will be presented block-randomized amygdala stimulation. |
| No stimulation | No intervention | –This part will include 24 randomly chosen images from each of four categories (total of 96 images varying in valence and arousal) and will be presented without amygdala stimulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age of 18 years or older
- FSIQ 75 and above or any equivalent test of generalized intelligence as determined by the PI to adequately predict engagement in the task
- Able to give independent consent for participation in the study
Key exclusion criteria (3 listed)
- Additional neurological disorders (such as dementia, stroke, brain tumor, etc.)
- Any psychiatric condition that would limit their ability to provide consent and/or perform study tasks within normal limits. This would be based on presurgical psychiatric assessment.
- Anything else, that in the opinion of the principal investigator, might preclude them from participating in the study
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 StimulationWe will use a computer randomized stimulation of specific areas in the amygdala while showing a computer randomized set of pictures. | Other | Stimulation |
Primary outcome
Z-score Gamma Power in Amygdala Per Valence Category
Time frame: 0 to 1000 MS following image presentation
Valence of each image is assessed by each subject using a Likert-type rating scale with a range of 1 to 7, where 1 represents most negative valence, 4 as neutral, and 7 as most positive. Valence categories are defined in the following manner: negative = 1.0 to 3.0, neutral = 3.1 to 5.0, negative = 5.1 to 7.0. Activation is measured by gamma frequency power (mµV²/30-100 Hz) at 0-1000 msec following image presentation in the basolateral amygdala electrode contact and compared to baseline defined as -500 msec to 0 of image presentation. Gamma power is transformed to z-score (baseline to following image presentation) for individual observations. Z-score of 0 indicates no change from baseline. Positive z-score indicates activation of the basolateral amygdala compared to baseline. Gamma frequency range is defined as 30-100 Hz in intracranial EEG. Power was estimated via a multitaper time-frequency transformation approach. Statistics was done using linear-mixed effects models (LMEs).
Effect of Amygdala Stimulation on Perception of Valence
Time frame: Valence ratings were assessed immediately following the viewing of each image during performance of the task.
Here we assess the effect of basolateral amygdala stimulation on valence ratings. Participants rate the emotional valence of each image in a Likert scale range of 1-7 (1= maximum negative valence, 4=maximum neutral valence, and 7 maximum positive valence) for each of the 96 images. We randomly apply electrical stimulation during perception and of 50% of the images presented. We analyze the effect of stimulation on image rating in the following manner: we grouped the images into three categories, negative (1 to 3), neutral (3.1 to 5), and positive (5.1 to 7) based on subject specific ratings. 2. We then used a multivariate model to assess the effect of stimulation on perception of neutral, negative, and positive categories across 9 patients.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. The study results will be available on ClinicalTrials.gov and will be published in appropriate clinical journal upon completion.
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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.
Krzysztof A Bujarski, MD principal investigator
Dartmouth-Hitchcock Medical Center
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 Stimulation in people with Refractory Epilepsy, run by Dartmouth-Hitchcock Medical Center 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 3 inclusion and 3 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 22 Sep 2025. 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?
Yes. Results are posted in the registry (first posted 22 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Z-score Gamma Power in Amygdala Per Valence Category (time frame: 0 to 1000 MS following image presentation). The study lists 2 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 22 Sep 2025.