Effects of Sensory Flicker and Electrical Flicker Stimulation

Brain Diseases Clinical Trial

Official title:

Neurophysiological and Behavioral Effects of Sensory Flicker and Electrical Flicker Stimulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04188834
• Other study ID #: IRB00107577
• Status: Completed
• Phase: N/A
• Start date: January 10, 2020
• Est. completion date: November 22, 2022

Study information

• Verified date: February 2024
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 22, 2022
• Est. primary completion date: November 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Diseases

Intervention

Device:
• Customized version of DAVID device
A customized version of the DAVID device will be used to expose participants to sensory flicker. The device consists of opaque glasses containing LEDs to present flickering light, as well as earbuds or headphones to present flickering sound.
• Blackrock CereStim
The Blackrock CereStim is a fully programmable neurostimulator. The current pulses generated by the Blackrock CereStim are intended to stimulate neurons in proximity to a set of electrodes.

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Georgia Institute of Technology

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The power spectral density of the LFP will be measured across stimulus frequencies and modalities of sensory flicker stimuli in visual areas, auditory areas, hippocampus, and prefrontal cortex. To evaluate the effects of sensory flicker on brain activity in various brain regions, researchers compared the average increase in oscillatory neural activity of given recorded brain regions during sensory stimulation, among the total number of recording locations that showed a significant response to sensory stimulation compared to baseline. In participants in whom a condition was repeated across multiple experimental sessions. If a location showed a significant response in multiple sessions, the data point that showed the highest level of response was kept. The average fold-change increase in oscillatory activity, 25th and 75th percentiles, within a region of interest is reported.	During experiment session (up to 2 hours) during hospital admission (up to 2 weeks)
Secondary	Effect of Sensory Flicker on the Rate of Interictal Epileptiform Discharges (IEDs) Which Represent Pathological Activity Often Observed in Epilepsy	The change of of the sensory flicker effect will be evaluated by the comparison of the whole-brain rate of IEDs between sensory flicker stimulation and baseline (no stimulation).	During experiment session (up to 2 hours) during hospital admission (up to 2 weeks)

External Links

•   Multisensory Flicker Modulates Widespread Brain Networks and Reduces Interictal Epileptiform Discharges in Humans