Brain DiseasesNCT04188834

Effects of Sensory Flicker and Electrical Flicker Stimulation

A study testing Customized version of DAVID device and Blackrock CereStim in people with Brain Diseases, run by Emory University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Brain Diseases
What is being tested?: Customized version of DAVID device and Blackrock CereStim
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 1 siteUnited States
Study dates: 10 Jan 2020to 22 Nov 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

Failure to meet any one inclusion criteria.

Trial locations and contacts

1 site in 1 country.

United States1 site

Emory University Hospital
Atlanta, Georgia, 30322

Other trials in United States

About this study

Official title: Neurophysiological and Behavioral Effects of Sensory Flicker and Electrical Flicker Stimulation

Read the 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.

Conditions: Brain Diseases
Being tested: Customized version of DAVID device, Blackrock CereStim
Keywords: Sensory Flicker Stimulation, Electrical Flicker Stimulation, Neurophysiological Effects, Behavioral Effects, Brain circuits modulation, Steady-state evoked potentials
Medical subject headings: Brain Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Customized version of DAVID deviceDevice
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 CereStimDevice
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.

Study groups in NCT04188834
Study group	Role	What they receive
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. Receives: 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. Receives: Device: Blackrock CereStim

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jan 202022 Nov 2022

First posted6 Dec 2019
Study start10 Jan 2020
Primary completion22 Nov 2022
Study completion22 Nov 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Brain DiseasesStudies of the same condition, open and under way.
More trials run by Emory UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04188834
Sponsor's protocol ID: IRB00107577
Status last verified: Feb 2024
First submitted: 4 Dec 2019
Last updated: 26 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: Individual participant and data that underlie the results reported after de-identification (text, tables, figures, and appendices) will be available. The study protocol, statistical analysis plan, analytic code will be made available immediately following publication with no end date.

Publications

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.
PubMed 36993248

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Brain Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Neurophysiological and Behavioral Effects of Sensory Flicker and Electrical Flicker Stimulation
ClinicalTrials.gov ID: NCT04188834
Acronym / sponsor ID: IRB00107577
Conditions: Brain Diseases
Keywords: Sensory Flicker Stimulation, Electrical Flicker Stimulation, Neurophysiological Effects, Behavioral Effects, Brain circuits modulation, Steady-state evoked potentials
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: Emory UniversityUniversity, hospital or other
Collaborators: Georgia Institute of Technology
Study start: 10 Jan 2020 (actual)
Primary completion: 22 Nov 2022 (actual)
Study completion: 22 Nov 2022 (actual)
First posted: 6 Dec 2019 (actual)
Results: Posted 26 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Sensory Flicker Stimulation	Experimental	Device: Customized version of DAVID deviceParticipants 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.
Electrical Flicker Stimulation	Active comparator	Device: Blackrock CereStimParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (1 listed)

Failure to meet any one inclusion criteria.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Customized version of DAVID deviceA 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.	Device	Sensory Flicker Stimulation
Blackrock CereStimThe 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.	Device	Electrical Flicker Stimulation

Primary outcome

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
Time frame: During experiment session (up to 2 hours) during hospital admission (up to 2 weeks)
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.

1 secondary outcome

Effect of Sensory Flicker on the Rate of Interictal Epileptiform Discharges (IEDs) Which Represent Pathological Activity Often Observed in Epilepsy
Time frame: During experiment session (up to 2 hours) during hospital admission (up to 2 weeks)

Results and safety

Results posted to the registry on 26 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sensory Flicker Stimulation	23	19

Primary outcome: 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

Time frame: During experiment session (up to 2 hours) during hospital admission (up to 2 weeks). Median (Inter-Quartile Range). Unit: Fold-change in power

Measure	Sensory Flicker Stimulation n = 19
Visual Region to 5.5Hz-V	4.6 (1.2 to 11.2)
Visual Region to 40Hz-V	4 (1.3 to 15.8)
Visual Region to 80Hz-V	1.1 (0.6 to 3.5)
Visual Region to 5.5Hz-A	0.5 (0.4 to 0.7)
Visual Region to 40Hz-A	0.4 (0.3 to 0.8)
Visual Region to 80Hz-A	0.6 (0.4 to 0.7)
Auditory Region to 5.5Hz-V	0.9 (0.6 to 2.0)
Auditory Region to 40Hz-V	0.7 (0.5 to 3.5)

Population analysed: Participants who completed study procedures and had valid data points for each frequency and region are included.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events that occurred during the experimental sessions (up to 2h) and were conducted during the patient's hospital stay are reported. Participant's hospital stay duration was strictly determined by the clinical team based on clinical needs and typically lasted about 2 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sensory Flicker Stimulation	0 of 23 (0%)	16 of 23 (69.6%)	0 of 23

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 36993248Blanpain 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.
Multisensory Flicker Modulates Widespread Brain Networks and Reduces Interictal Epileptiform Discharges in HumansLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Individual participant and data that underlie the results reported after de-identification (text, tables, figures, and appendices) will be available. The study protocol, statistical analysis plan, analytic code will be made available immediately following publication with no end date.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Joseph Manns, PhD principal investigator

Emory University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Customized version of DAVID device and Blackrock CereStim in people with Brain Diseases, run by Emory University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: During experiment session (up to 2 hours) during hospital admission (up to 2 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04188834, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.