Effects of Green Light Exposure on Epileptic Spikes in Patients With Refractory Epilepsy
1 other identifier
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2019
CompletedFirst Posted
Study publicly available on registry
February 27, 2019
CompletedStudy Start
First participant enrolled
July 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedMarch 9, 2022
March 1, 2022
3.4 years
February 25, 2019
March 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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.
120 minutes
Secondary Outcomes (3)
To consider probable confounders, such as etiology and comorbidities, this information will be acquired with standardized NIH epilepsy data acquisition forms for (1):
10 minutes
To consider probable confounders, such as etiology and comorbidities, this information will be acquired through routine clinical care documentation by the study MD for (2):
10 minutes
To consider probable confounders, such as etiology and comorbidities, this information will be acquired through routine clinical care documentation by the study MD for (3):
10 minutes
Study Arms (1)
Open Label, Green Light Exposure
EXPERIMENTALThis 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
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Boston Children's Hospital
Boston, Massachusetts, 02130, United States
Related Publications (3)
Noseda R, Bernstein CA, Nir RR, Lee AJ, Fulton AB, Bertisch SM, Hovaguimian A, Cestari DM, Saavedra-Walker R, Borsook D, Doran BL, Buettner C, Burstein R. Migraine photophobia originating in cone-driven retinal pathways. Brain. 2016 Jul;139(Pt 7):1971-86. doi: 10.1093/brain/aww119. Epub 2016 May 17.
PMID: 27190022BACKGROUNDNoseda R, Kainz V, Jakubowski M, Gooley JJ, Saper CB, Digre K, Burstein R. A neural mechanism for exacerbation of headache by light. Nat Neurosci. 2010 Feb;13(2):239-45. doi: 10.1038/nn.2475. Epub 2010 Jan 10.
PMID: 20062053BACKGROUNDNoseda R, Lee AJ, Nir RR, Bernstein CA, Kainz VM, Bertisch SM, Buettner C, Borsook D, Burstein R. Neural mechanism for hypothalamic-mediated autonomic responses to light during migraine. Proc Natl Acad Sci U S A. 2017 Jul 11;114(28):E5683-E5692. doi: 10.1073/pnas.1708361114. Epub 2017 Jun 26.
PMID: 28652355BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexander Rotenberg, MD, PhD
Boston Children's Hospital
- PRINCIPAL INVESTIGATOR
Phillip Pearl, MD
Boston Children's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 25, 2019
First Posted
February 27, 2019
Study Start
July 22, 2019
Primary Completion
December 31, 2022
Study Completion
June 1, 2023
Last Updated
March 9, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share