Clinical trial NCT05292183: Modulation of Emotion Perception in Humans Via Amygdala Stimulation
Official title: Neuromodulation of Affective Valence in Humans by Amygdala Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractory Epilepsy
Keywords: Human Amygdala
Deep Brain Stimulation
Psychiatric Disorders
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2022-03-23
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: BASIC_SCIENCE

Brief 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 - 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:

1. 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.
2. 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.
3. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Better understand neural circuits responsible for processing valence as measured by the power in the gamma band in the valence circuit
timeFrame: Evaluated for each patient during monitoring period of approximately 2 weeks.
measure: Better understand the neural circuits responsible for processing valence by measuring negative and positive valence.
timeFrame: Evaluated for each patient during monitoring period of approximately 2 weeks.
Secondary outcomes:
measure: Measure whether amygdala can be a suitable DBS target through comparison of EEG and reported perceptions.
timeFrame: Evaluated for each patient during monitoring period of approximately 2 weeks.
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Krzysztof A Bujarski, MD
role: PRINCIPAL_INVESTIGATOR
References: