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Procedure
Customized version of DAVID device for Brain Diseases
N/A
Waitlist Available
Led By Joseph Manns, PhD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during experiment session (up to 2 hours) during hospital admission (up to 2 weeks)
Awards & highlights
Study Summary
This trial will compare the effects of two different methods of stimulating deep brain regions in humans - sensory flicker and direct electrical stimulation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during experiment session (up to 2 hours) during hospital admission (up to 2 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during experiment session (up to 2 hours) during hospital admission (up to 2 weeks)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Fold-change in Oscillatory Activity (Power Spectral Density) in Response to Exposure to Sensory Flicker: Comparing Mean Power Spectral Density at the Frequency of Flicker Being Presented Between Flicker and Baseline Periods
Secondary outcome measures
Effect of Sensory Flicker on the Rate of Interictal Epileptiform Discharges (IEDs) Which Represent Pathological Activity Often Observed in Epilepsy
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Sensory Flicker StimulationExperimental Treatment1 Intervention
Participants will be exposed for about 10 to 60 minutes at a time, to a sequence of sensory flicker trials each lasting a few seconds to 5 minutes, while their eyes are open or closed. Each trial may include the following modalities and frequencies of flicker:
Modalities: auditory only, visual only, or audiovisual combined.
Frequencies: random, or anywhere from 3Hz to 200Hz.
Additionally, subjects may be exposed to individual pulses of light and/or sound, i.e. around or less than 1 pulse /second, for up to 20 minutes at a time.
Group II: Electrical Flicker StimulationActive Control1 Intervention
Participants will be exposed to direct electrical brain stimulation with low-amplitude current, at given flicker frequencies. Participants will be exposed to frequencies ranging from 5-100Hz, for up to 10 seconds at a time. Initially, frequencies of 5.5Hz and 40Hz will be tested.
During brain stimulation sessions, bipolar electrical stimulation will be applied to one or more areas of the brain at a time either with or without associated memory tasks. Stimulation in the absence of any memory task will be applied to assess the subject's neurophysiological response to stimulation and to identify the optimal stimulation parameters for use during memory tasks. Stimulation during behavioral tasks will be applied in an attempt to affect the subject's memory.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Customized version of DAVID device
2020
N/A
~30
Find a Location
Who is running the clinical trial?
Georgia Institute of TechnologyOTHER
48 Previous Clinical Trials
5,511 Total Patients Enrolled
Emory UniversityLead Sponsor
1,638 Previous Clinical Trials
2,560,509 Total Patients Enrolled
3 Trials studying Brain Diseases
616 Patients Enrolled for Brain Diseases
Joseph Manns, PhDPrincipal InvestigatorEmory University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You do not have a condition where certain sensory experiences can cause seizures.
Research Study Groups:
This trial has the following groups:- Group 1: Sensory Flicker Stimulation
- Group 2: Electrical Flicker 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.
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