NCT04188834

Effects of Sensory Flicker and Electrical Flicker Stimulation

Completed NA Results posted Last updated 26 March 2024

What this trial tests

NA trial testing Customized version of DAVID device in Brain Diseases in 23 participants. Completed in 22 November 2022.

Timeline

10 January 2020

Primary endpoint
22 November 2022

22 November 2022

Quick facts

Lead sponsor	Emory University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	crossover
Masking	none
Primary purpose	basic science
Enrollment	23
Start date	10 January 2020
Primary completion	22 November 2022
Estimated completion	22 November 2022
Sites	1 location across United States

Drugs / interventions tested

• Customized version of DAVID device
• Blackrock CereStim

Conditions studied

• Brain Diseases — all drugs for Brain Diseases →

Sponsor

Emory University

Who can join

18 and older, any sex, with Brain Diseases. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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 Primary · 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 mult

Visual Region to 5.5Hz-V

Group	Value	95% CI
Sensory Flicker Stimulation	4.6	1.2 – 11.2

Visual Region to 40Hz-V

Group	Value	95% CI
Sensory Flicker Stimulation	4	1.3 – 15.8

Visual Region to 80Hz-V

Group	Value	95% CI
Sensory Flicker Stimulation	1.1	0.6 – 3.5

Visual Region to 5.5Hz-A

Group	Value	95% CI
Sensory Flicker Stimulation	0.5	0.4 – 0.7

Visual Region to 40Hz-A

Group	Value	95% CI
Sensory Flicker Stimulation	0.4	0.3 – 0.8

Visual Region to 80Hz-A

Group	Value	95% CI
Sensory Flicker Stimulation	0.6	0.4 – 0.7

Auditory Region to 5.5Hz-V

Group	Value	95% CI
Sensory Flicker Stimulation	0.9	0.6 – 2.0

Auditory Region to 40Hz-V

Group	Value	95% CI
Sensory Flicker Stimulation	0.7	0.5 – 3.5

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

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).

Group	Value	95% CI
Sensory Flicker Stimulation	-3.0	-4.5 – -1.6

Adverse events — posted to ClinicalTrials.gov

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.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Sensory Flicker Stimulation

Serious: 0/23 (0%)

Deaths: 0/23

Other adverse events (4 terms — click to expand)

Reaction	System	Sensory Flicker Stimulation
Headache or discomfort	Nervous system disorders	—
Fatigue	General disorders	—
Miscellaneous	General disorders	—
Seizure likely unrelated to experiment	Nervous system disorders	—

Data from ClinicalTrials.gov NCT04188834 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Multisensory flicker modulates widespread brain networks and reduces interictal epileptiform discharges.
   Blanpain LT, Cole ER, Chen E, Park JK, et al · · 2024 · cited 29× · PMID 38605017 · DOI 10.1038/s41467-024-47263-y