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Electrical Stimulation
Amygdala Stimulation for Epilepsy
N/A
Waitlist Available
Led By Krzysztof A Bujarski, MD
Research Sponsored by Dartmouth-Hitchcock Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age of 18 years or older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up evaluated for each patient during monitoring period of approximately 2 weeks.
Awards & highlights
Study Summary
This trial will enroll patients with epilepsy who have intracranial EEG electrodes. The study will record brain signals from areas important in social and emotional processing, and test how electrical brain stimulation affects such processing.
Who is the study for?
This trial is for adults over 18 with epilepsy who are being evaluated for surgery and can consent to participate. They must have normal intelligence levels and be able to engage in the study tasks. People with psychiatric conditions affecting consent or task performance, or other neurological disorders like dementia, stroke, or brain tumors cannot join.Check my eligibility
What is being tested?
The study tests how electrical stimulation (neuromodulation) of the brain affects emotion perception in epilepsy patients undergoing surgical evaluation. Participants will view emotional images while receiving imperceptible electric currents to map brain function related to social and emotional processing.See study design
What are the potential side effects?
Since the electrical current used is small and designed to be imperceptible, no significant side effects are expected from this neuromodulation procedure during the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ evaluated for each patient during monitoring period of approximately 2 weeks.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~evaluated for each patient during monitoring period of approximately 2 weeks.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Better understand neural circuits responsible for processing valence as measured by the power in the gamma band in the valence circuit
Better understand the neural circuits responsible for processing valence by measuring negative and positive valence.
Secondary outcome measures
Measure whether amygdala can be a suitable DBS target through comparison of EEG and reported perceptions.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: StimulationExperimental Treatment1 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 block-randomized amygdala stimulation.
Group II: No stimulationActive Control1 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.
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Who is running the clinical trial?
National Institute of Mental Health (NIMH)NIH
2,785 Previous Clinical Trials
2,689,740 Total Patients Enrolled
9 Trials studying Epilepsy
5,316 Patients Enrolled for Epilepsy
Dartmouth-Hitchcock Medical CenterLead Sponsor
524 Previous Clinical Trials
2,543,323 Total Patients Enrolled
12 Trials studying Epilepsy
1,150 Patients Enrolled for Epilepsy
Krzysztof A Bujarski, MDPrincipal InvestigatorDartmouth-Hitchcock Medical Center
1 Previous Clinical Trials
175 Total Patients Enrolled
1 Trials studying Epilepsy
175 Patients Enrolled for Epilepsy
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have no other neurological disorders like dementia or stroke.I am 18 years old or older.I can make my own decisions about joining this study.You have a certain level of intelligence as determined by a test given by the study leader.
Research Study Groups:
This trial has the following groups:- Group 1: No stimulation
- Group 2: Stimulation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies available to potential participants in this trial?
"Affirmative. Clinicaltrials.gov hosts the information that this medical experiment, which was first announced on March 31st 2022, is actively inviting participants to take part in it. 16 patients must be enrolled from 1 research site."
Answered by AI
What is the scale of enrollment for this project?
"Affirmative. Data hosted on clinicaltrials.gov reveals that this medical investigation, which was first posted in March of 2022, is actively accepting patients. A total of 16 individuals require recruitment from 1 facility."
Answered by AI
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