Drug Resistant EpilepsyNCT07145489
Infrared Photobiomodulation in Humans With Epilepsy
A study testing photobiomodulation in people with Drug Resistant Epilepsy, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Resistant Epilepsy
- What is being tested?
- photobiomodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2025to 25 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Implanted intracranial neurostimulation device (DBS or RNS)
- Intracranial shunt
- Skin photosensitivity
- Cancer on scalp
- Taking any medication that can cause photosensitivity
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
BIDMC
Boston, Massachusetts, 02215
Daniel Goldenholz, MD PhD, 617-632-8930, daniel.goldenholz@bidmc.harvard.edu
Daniel Goldenholz, MD PhD
About this study
Official title: An Open Label Pilot Study of Infrared Photobiomodulation in Humans With Epilepsy
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.
Read the detailed description
Epilepsy affects 12 out of every 1000 people in the United States (1.2%). Of those, roughly 40% have drug-resistant epilepsy, meaning seizures do not stop despite good doses given with two different anti-seizure medications. Patients in this situation have several options (1) try additional medications (2) consider surgery to remove the part of the brain causing seizures, if possible (3) consider neuromodulation devices that change the brain activity using electricity in the brain (also a surgery) (4) try special diets such as the ketogenic diet which changes the fuel used by the brain by only eating certain foods. Despite these options, a large number of patients continue to have seizures. There is a great need for new treatments for drug resistant epilepsy.
The main purpose of this study is to determine if a new treatment is safe and well tolerated. Everyone in this study will receive the Red Light Therapy Hat which is investigational and is not approved by the FDA. The investigators do not know all the ways that this study treatment may affect people. This study is intended to hopefully help the participants, and the investigators hope the information from this study will help us develop a better treatment for drug resistant epilepsy in the future.
This particular investigational technology has been approved by the FDA for use in other diseases or conditions, but the investigators do not yet know if it is useful or safe as a treatment for drug resistant epilepsy.
- Conditions
- Drug Resistant Epilepsy
- Being tested
- photobiomodulation
- Keywords
- epilepsy, photobiomodulation, seizure
- Medical subject headings
- Drug Resistant Epilepsy, Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
photobiomodulationDevice
a hat with infrared lights will be worn for 30 minutes daily for 6 months
| Study group | Role | What they receive |
|---|---|---|
| photobiomodulation | Experimental | participants will use photobiomodulation daily for 6 months Receives: Device: photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
seizure rate reduction
fraction of seizures reduced by therapy assessed by individual baseline rate
Measured: 6 months
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?
Measured: 6 months
Secondary outcomes (1)
seizure duration
fraction of seizure duration reduction assessed by baseline seizure durations
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start25 Nov 2025
- Primary completion25 Sep 2026 (estimated)
- Study completion25 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Resistant EpilepsyStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Goldenholz, Beth Israel Deaconess Medical Center
- Investigators
- Daniel Goldenholz, MD PhD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145489
- Sponsor's protocol ID
- 2025P000606
- Status last verified
- Feb 2026
- First submitted
- 19 Aug 2025
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data about seizure rates, seizure durations and side effects
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Pilot Study of Infrared Photobiomodulation in Humans With Epilepsy
- ClinicalTrials.gov ID
- NCT07145489
- Acronym / sponsor ID
- 2025P000606
- Conditions
- Drug Resistant Epilepsy
- Keywords
- epilepsy, photobiomodulation, seizure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- 25 Sep 2026 (estimated)
- Study completion
- 25 Sep 2027 (estimated)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Epilepsy affects 12 out of every 1000 people in the United States (1.2%). Of those, roughly 40% have drug-resistant epilepsy, meaning seizures do not stop despite good doses given with two different anti-seizure medications. Patients in this situation have several options (1) try additional medications (2) consider surgery to remove the part of the brain causing seizures, if possible (3) consider neuromodulation devices that change the brain activity using electricity in the brain (also a surgery) (4) try special diets such as the ketogenic diet which changes the fuel used by the brain by only eating certain foods. Despite these options, a large number of patients continue to have seizures. There is a great need for new treatments for drug resistant epilepsy.
The main purpose of this study is to determine if a new treatment is safe and well tolerated. Everyone in this study will receive the Red Light Therapy Hat which is investigational and is not approved by the FDA. The investigators do not know all the ways that this study treatment may affect people. This study is intended to hopefully help the participants, and the investigators hope the information from this study will help us develop a better treatment for drug resistant epilepsy in the future.
This particular investigational technology has been approved by the FDA for use in other diseases or conditions, but the investigators do not yet know if it is useful or safe as a treatment for drug resistant epilepsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| photobiomodulation | Experimental | Device: photobiomodulationparticipants will use photobiomodulation daily for 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Implanted intracranial neurostimulation device (DBS or RNS)
- Intracranial shunt
- Skin photosensitivity
- Cancer on scalp
- Taking any medication that can cause photosensitivity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| photobiomodulationa hat with infrared lights will be worn for 30 minutes daily for 6 months | Device | photobiomodulation |
Primary outcome
seizure rate reduction
Time frame: 6 months
fraction of seizures reduced by therapy assessed by individual baseline rate
tolerability of daily photobiomodulation
Time frame: 6 months
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?
1 secondary outcome
seizure duration
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: Yes. De-identified data about seizure rates, seizure durations and side effects
Related trials for Drug Resistant Epilepsy
Not yet recruiting
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Effect of Blue Light on Vagus Nerve Stimulation in Patients With Refractory Epilepsy
Refractory Epilepsy
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Identification of Biomarkers for Vagus Nerve Stimulation in Patients With Refractory Epilepsy
Refractory Epilepsy
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Characterisation of Laryngeal Evoked Potentials Induced by Vagus Nerve Stimulation in Refractory Epilepsy Patients
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RecruitingObservational study
Long-Term Epilepsy Outcomes in Children With a History of Perinatal Stroke
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel Goldenholz, MD PhD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing photobiomodulation in people with Drug Resistant Epilepsy, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Goldenholz, MD, PhD (617-632-8930, daniel.goldenholz@bidmc.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
seizure rate reduction (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026; AzTrials last refreshed its copy on 4 Nov 2026.