N/A
Completed N=23
Effects of Sensory Flicker and Electrical Flicker Stimulation
Brain Diseases
Source: ClinicalTrials.gov NCT04188834 ↗
Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcomePrimary: 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 — 4.6; 4; 1.1; 0.5 Fold-change in power
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
4.6; 4; 1.1; 0.5; 0.4; 0.6 | — |
| SECONDARY Effect of Sensory Flicker on the Rate of Interictal Epileptiform Discharges (IEDs) Which Represent Pathological Activity Often Observed in Epilepsy |
-3.0 | — |
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.
Data sourced from ClinicalTrials.gov (NCT04188834). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.