Effects of Green Light Exposure on Epileptic Spikes in Patients With Refractory Epilepsy
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Neurology, Epilepsy |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | Any - 30 |
| Updated: | 3/1/2019 |
| Start Date: | March 30, 2019 |
| End Date: | November 1, 2020 |
| Contact: | Harper L Kaye |
| Email: | neuromodulation@childrens.harvard.edu |
| Phone: | 617-355-4875 |
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.
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.
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).
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).
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
We found this trial at
1
site
300 Longwood Ave
Boston, Massachusetts 02115
Boston, Massachusetts 02115
(617) 355-6000
Principal Investigator: Alexander Rotenberg, MD, Ph D
Phone: 617-355-4875
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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