Effects of Sensory Flicker and Electrical Flicker Stimulation

NCT04188834 | Completed Results FDA Device

• 1 other identifier: IRB00107577
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Diseases

Keywords

Sensory Flicker Stimulation; Electrical Flicker Stimulation; Neurophysiological Effects; Behavioral Effects; Brain circuits modulation; Steady-state evoked potentials

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Effect of Sensory Flicker on the Rate of Interictal Epileptiform Discharges (IEDs) Which Represent Pathological Activity Often Observed in Epilepsy

  During experiment session (up to 2 hours) during hospital admission (up to 2 weeks)

Study Arms (2)

Sensory Flicker Stimulation

EXPERIMENTAL

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.

Device: Customized version of DAVID device

Electrical Flicker Stimulation

ACTIVE COMPARATOR

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.

Device: Blackrock CereStim

Interventions

Customized version of DAVID device 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.

Sensory Flicker Stimulation

Blackrock CereStim DEVICE

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.

Electrical Flicker Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead
• Georgia Institute of Technology: collaborator

Study Sites (1)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Related 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.

  PMID: 36993248 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Brain Diseases

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Dr. Annabelle Singer
• Organization: Georgia Institute of Technology Atlanta

annabelle.singer@bme.gatech.edu

404.385.4936

Study Officials

• Joseph Manns, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 6, 2019
• Study Start: January 10, 2020
• Primary Completion: November 22, 2022
• Study Completion: November 22, 2022
• Last Updated: March 26, 2024
• Results First Posted: March 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Immediately following publication. No end date.
• Access Criteria: De-identified, minimally processed data and processed data will be made available upon request. Data may be requested by contacting Dr. Annabelle Singer at annabelle.singer@bme.edu

Locations

US (1)