Summary
The purpose of this study is to obtain preliminary data in advance of a larger clinical trial aimed to test whether a single session of green light exposure can lead to a clinically significant reduction in epileptic spikes in patients with medically-refractory epilepsy. As this is a potentially fragile patient population, the study will test safety and tolerability as well as efficacy.
Conditions
Epilepsy, Epilepsy Intractable
Recruitment Status
Unknown status
Detailed Description
The trial is designed to detect (1) change in spike frequency on EEG before and after exposure to low intensity green light, and (2) presence or absence of neurologic/systemic symptoms referable to exposure of the pre-selected duration, intensity, and band of green light. Our primary aim is to determine whether prolonged exposure (120 minutes) to a narrow band of green light (520-540 nm) at low intensities (1-10 cd/m2) alters the pattern of electrical activity in the cortex of epilepsy patients. The primary outcome measure for this aim will be the fraction of patients in which the number of epileptiform discharges (spikes or sharp waves) decrease, per recording, in response to green light exposure, as determined by spike frequency detected via scalp EEG before and after green light exposure. The investigators anticipate that the primary outcome measures of safety and tolerability will not differ from the previously established measures of green light exposure for migraine (Noseda et al. 2016). The investigators will use only low intensities (1-10 cd/m2) of green light which is well tolerated in adults and children (Main et al. 2000). In addition, given limited experience with conventional green light exposure in epilepsy, the investigators predict that post-exposure to green light, patients will have an improvement on the post-exposure EEG (decreased spike frequency).
Eligibility Criteria
Inclusion Criteria:
6 months-30 years of age
Epileptic spike frequency ≥1 epileptic spike per minute at baseline, as determined by scalp EEG recording
Admitted to the Boston Children's Hospital Epilepsy Long Term Monitoring Unit at the time of enrollment
Exclusion Criteria:
Cataracts
Retinol disease
Any history of or currently not well controlled ophthalmic disease that prevents transmission from the retina to the optic nerve
Clinical seizure 4 hours or less before anticipated green light exposure
Intervention
Intervention Type
Intervention Name
Device
Green Light Exposure
Phase
Not Applicable
Gender
All
Min Age
6 Months
Max Age
30 Years
Download Date
March 9, 2022
Principal Investigator
Alexander Rotenberg
Primary Contact Information
Paul MacMullin
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: