NCT03857074

Effects of Green Light Exposure on Epileptic Spikes in Patients With Refractory Epilepsy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 6 Months – 30 Years
• Healthy volunteers: Not accepted

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.

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).

Conditions

• Epilepsy
• Epilepsy Intractable

Interventions

Type	Name	Description
DEVICE	Green Light Exposure	To test whether exposure to a narrow band of green light (520-540 nm) at low intensities (1-10 cd/m2) decreases interictal epileptiform discharges in patients with epilepsy. The overall hypothesis for this open-label trial is based on findings in patients with migraine that indicate an engagement of thalamocortical inhibitory circuits by green light.

Timeline

• Start date: 2019-07-22
• Primary completion: 2022-12-31
• Completion: 2023-06-01
• First posted: 2019-02-27
• Last updated: 2022-03-09

Locations

1 site across 1 country: United States