Brain Stimulation for Aura

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Dartmouth-Hitchcock Medical Center, Lebanon, NH
Aura
Brain Stimulation - Procedure
Eligibility
18+
All Sexes
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Study Summary

This study will enroll patients with epilepsy who are being evaluated for epilepsy surgery and have electrodes implanted in the brain and/or have electrodes on the scalp. Additionally, this study will recruit normal and online controls (participants who do not have epilepsy). Participants will be asked to participate in 1 to 2 (30-90 minutes) daily sessions designed to test aspects of human cognition such as memory, speech, language, feeling, movement, attention, sound perception, and emotions. Generally, this will involve working on a computer, looking at pictures or watching videos, and answering questions. Additionally, participants may be asked to be hooked up to additional equipment such as eye tracker, electrical stimulator, heart rate monitor, sweat monitor or other non-invasive equipment. The overall aim of this study is to use human intracranial electrophysiology (the recording of the electrical activity of the human brain) to study localization and function of the human brain.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

6 Primary · 4 Secondary · Reporting Duration: Evaluated for each patient during monitoring period of approximately 2 weeks.

Week 2
Measure the degree of correlation between the brain activation and cardiac physiology.
Measure the degree of correlation between the brain activation and sweat variations.
The degree of correlation between the brain activation and electrodermal activity.
The degree of correlation between the brain activation and respiratory activity.
Using scalp and intracranial EEG, measure changes in electrical activity of the human brain associated with attention and executive function.
Using scalp and intracranial EEG, measure changes in electrical activity of the human brain associated with emotions.
Using scalp and intracranial EEG, measure changes in electrical activity of the human brain associated with language.
Using scalp and intracranial EEG, measure changes in electrical activity of the human brain associated with memory.
Using scalp and intracranial EEG, measure changes in electrical activity of the human brain associated with movement.
Using scalp and intracranial EEG, measure changes in electrical activity of the human brain associated with sound perception.

Trial Safety

Safety Progress

1 of 3

Trial Design

4 Treatment Groups

Normal Controls
1 of 4
Online Controls
1 of 4
Scalp EEG (electrodes are placed on a participant's scalp)
1 of 4
Invasive EEG (electrodes are implanted in a participant's brain)
1 of 4
Active Control
Experimental Treatment

175 Total Participants · 4 Treatment Groups

Primary Treatment: Brain Stimulation · No Placebo Group · N/A

Scalp EEG (electrodes are placed on a participant's scalp)Experimental Group · 7 Interventions: Memory Tasks, Language tasks, Attention/arousal tasks, Visuospatial tasks, Recording of facial expressions, Social Emotional Task, Auditory Tasks · Intervention Types: Other, Other, Other, Other, Other, Other, Other
Invasive EEG (electrodes are implanted in a participant's brain)Experimental Group · 8 Interventions: Memory Tasks, Language tasks, Attention/arousal tasks, Visuospatial tasks, Recording of facial expressions, Social Emotional Task, Auditory Tasks, Brain Stimulation · Intervention Types: Other, Other, Other, Other, Other, Other, Other, Procedure
Normal ControlsActiveComparator Group · 6 Interventions: Memory Tasks, Language tasks, Attention/arousal tasks, Visuospatial tasks, Recording of facial expressions, Social Emotional Task · Intervention Types: Other, Other, Other, Other, Other, Other
Online ControlsActiveComparator Group · 6 Interventions: Memory Tasks, Language tasks, Attention/arousal tasks, Visuospatial tasks, Recording of facial expressions, Social Emotional Task · Intervention Types: Other, Other, Other, Other, Other, Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: evaluated for each patient during monitoring period of approximately 2 weeks.

Trial Background

Krzysztof Bujarski, Section Chief, Neurology
Principal Investigator
Dartmouth-Hitchcock Medical Center
Closest Location: Dartmouth-Hitchcock Medical Center · Lebanon, NH
2001First Recorded Clinical Trial
0 TrialsResearching Aura
335 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a minimum age of 18 years.
You have a diagnosis of refractory epilepsy

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.