Clinical trial NCT04188834: Effects of Sensory Flicker and Electrical Flicker Stimulation
Official title: Neurophysiological and Behavioral Effects of Sensory Flicker and Electrical Flicker Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Diseases
Keywords: Sensory Flicker Stimulation
Electrical Flicker Stimulation
Neurophysiological Effects
Behavioral Effects
Brain circuits modulation
Steady-state evoked potentials
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Georgia Institute of Technology
First posted: 2019-12-06
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The study will evaluate whether sensory flicker can modulate neural activity of deep brain regions in humans, and whether it can have relevant effects on behavior. Moreover, it will compare those effects to the gold-standard method of modulating brain circuits, direct electrical stimulation of the brain (the same mechanism as deep brain stimulation), using a powerful within-subjects design.

Detailed description: Clinical trials have explored the modulation of brain circuits to treat several brain disorders, including Parkinson's Disease, Alzheimer's Disease (AD), depression, and Obsessive-Compulsive Disorder (OCD). However, current means to non-invasively modulate brain activity are limited.

The study will evaluate whether sensory flicker can modulate neural activity of deep brain regions in humans, and whether it can have relevant effects on behavior. Moreover, it will compare those effects to the gold-standard method of modulating brain circuits, direct electrical stimulation of the brain (the same mechanism as deep brain stimulation), using a powerful within-subjects design.

Eligibility criteria: Inclusion Criteria:

* Adult (\>18 years, regardless of gender, race or ethnicity).
* To be implanted with intracranial depth or grid/strip electrodes for surgical evaluation.
* Patient was not shown, during phase I seizure monitoring, to exhibit abnormal EEG activity in response to photic stimulation, and is not clinically suspected to be susceptible to photic-induced seizures.
* Patient has no pre-existing diagnosis of autism.
* Patient is not considered at risk for psychogenic nonepileptic seizures (PNES) triggered by sensory stimulation.
* Fluent in English.
* Able to understand an informed consent (comprehend potential risks and benefits).
* Give written and verbal informed consent to all experiments patient would participate in.

Exclusion Criteria:

* Failure to meet any one inclusion criteria.

Primary outcomes:
measure: 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
timeFrame: During experiment session (up to 2 hours) during hospital admission (up to 2 weeks)
Secondary outcomes:
measure: Effect of Sensory Flicker on the Rate of Interictal Epileptiform Discharges (IEDs) Which Represent Pathological Activity Often Observed in Epilepsy
timeFrame: During experiment session (up to 2 hours) during hospital admission (up to 2 weeks)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Joseph Manns, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blanpain LT, Chen E, Park J, Walelign MY, Gross RE, Cabaniss BT, Willie JT, Singer AC. Multisensory Flicker Modulates Widespread Brain Networks and Reduces Interictal Epileptiform Discharges in Humans. medRxiv [Preprint]. 2023 Mar 17:2023.03.14.23286691. doi: 10.1101/2023.03.14.23286691.