Recruiting

Green Light Exposure

Sponsor:

Boston Children's Hospital

Code:

NCT03857074

Conditions

Epilepsy

Epilepsy Intractable

Eligibility Criteria

Sex: All

Age: 0 - 30

Healthy Volunteers: Not accepted

Interventions

Green Light Exposure

Study Details

Brief 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

Study ID

NCT03857074

Start date

Jul 22, 2019

Status verified date

Mar, 2022

Completion date

Jun 1, 2023

Anticipated

Primary completion date

Dec 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 30

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

16 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Open Label, Green Light Exposure

This is a single-center, open label, pilot feasibility study. Patients with epilepsy will be exposed to a narrow band of green light at low intensities (1-10 cd/m2). The investigators will record 30 minutes of scalp EEG prior to the light exposure and 30 minutes of scalp EEG recording post-light exposure. The number of epileptic spikes per minute at baseline will be compared to epileptic spike count per minute post-treatment, to determine whether green light exposure effectively decreases the number of epileptic spikes, in patients with ≥1 epileptic spike per minute at baseline.

Interventions

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.

Primary outcome measure

  • Effects of exposure to a narrow band of green light (520-540 nm) at low intensities (1-10 cd/m2) on the pattern of electrical activity in the cortex of epilepsy patients. [ Time Frame: 120 minutes ]

Central Contacts and Locations

Central contacts

Paul MacMullin

Paul.MacMullin@childrens.harvard.edu

Melissa DiBacco, MD

617-919-4617Melissa.Dibacco@childrens.harvard.edu

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02130

Contacts

Paul MacMullin

Paul.MacMullin@childrens.harvard.edu

Principal Investigator:

Alexander Rotenberg, MD, Ph D

More Information

Sponsor

Boston Children's Hospital

Last update posted

Mar 9, 2022

Last verified

Mar, 2022

Keywords

  • Refractory Epilepsy
  • Green Light Exposure
  • Epileptic Spikes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2022-03-09.