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

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ClinicalTrials.gov Identifier: NCT03857074
Recruitment Status : Recruiting
First Posted : February 27, 2019
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Alexander Rotenberg, Boston Children’s Hospital

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.

Condition or disease Intervention/treatment Phase
Epilepsy Epilepsy Intractable Device: Green Light Exposure Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This is a single-center, open label, pilot feasibility study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Green Light Exposure on Epileptic Spikes in Patients With Refractory Epilepsy
Estimated Study Start Date : July 22, 2019
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : November 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  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. [ Time Frame: 120 minutes ]
    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.


Secondary Outcome Measures :
  1. To consider probable confounders, such as etiology and comorbidities, this information will be acquired with standardized NIH epilepsy data acquisition forms for (1): [ Time Frame: 10 minutes ]
    Additional anticipated variable (1) patient demographics (age, gender, age of seizure onset, and epilepsy type), will be collected via a 'Demographics' Form.

  2. 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): [ Time Frame: 10 minutes ]
    Additional anticipated variable (2) EEG monitoring findings: The study MD will review prior clinical EEG findings per participant.

  3. 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): [ Time Frame: 10 minutes ]
    Additional anticipated variable (3) Imaging results: The study MD will review prior clinical imaging findings per participant.



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Ages Eligible for Study:   6 Months to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03857074


Contacts
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Contact: Harper L Kaye 617-355-4875 neuromodulation@childrens.harvard.edu

Locations
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United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02130
Contact: Harper L Kaye    617-355-4875    neuromodulation@childrens.harvard.edu   
Principal Investigator: Alexander Rotenberg, MD, Ph D         
Principal Investigator: Phillip Pearl, MD         
Sub-Investigator: Harper L Kaye         
Sponsors and Collaborators
Boston Children’s Hospital
Investigators
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Principal Investigator: Alexander Rotenberg, MD, PhD Boston Children’s Hospital
Principal Investigator: Phillip Pearl, MD Boston Children’s Hospital

Publications:
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Responsible Party: Alexander Rotenberg, Co-Principal Investigator, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT03857074     History of Changes
Other Study ID Numbers: IRB-P00030191
First Posted: February 27, 2019    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alexander Rotenberg, Boston Children’s Hospital:
Refractory Epilepsy
Green Light Exposure
Epileptic Spikes
Additional relevant MeSH terms:
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Epilepsy
Drug Resistant Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases