Infrared Photobiomodulation in Humans With Epilepsy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeth Israel Deaconess Medical Center

About this trial

Drug-resistant epilepsy represents roughly 40% of people with epilepsy. It is very challenging to stop seizures in this condition, and the treatment options are limited. This study aims to investigate a new treatment that involves using infra-red light. In animals, this treatment has shown promise as a possible way to reduce seizures, but it has not been tested in humans for this. The investigators are interested to know if it can reduce seizures, and how comfortable it is to be treated with this therapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Drug resistant epilepsy

Age 18 or older

Average seizure rate of at least 2 seizures per month

Accurate seizure diary with at least 3 months recorded

Disqualifiers

Implanted intracranial neurostimulation device (DBS or RNS)

Intracranial shunt

Skin photosensitivity

Cancer on scalp

Trial design

Design model

Single group

Treatments tested in this trial

  • photobiomodulation

    Device

    a hat with infrared lights will be worn for 30 minutes daily for 6 months

Treatment groups

13 Participants
are divided into 1 treatment group
Group A: photobiomodulationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

seizure rate reduction

fraction of seizures reduced by therapy assessed by individual baseline rate

Time frame
6 months
2

tolerability of daily photobiomodulation

Do participants find it reasonable to use the therapy daily or do they request exiting from the study? Do participants report significant side effects as reported by weekly check-ins that make the therapy uncomfortable or intolerable?

Time frame
6 months

Secondary outcomes

1

seizure duration

fraction of seizure duration reduction assessed by baseline seizure durations

Time frame
6 months

Other outcomes

Sponsors and contacts

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