Bipolar DisorderNCT05354895
Oxygenating the Brain With Laser Therapy
A study testing Transcranial infrared laser stimulation in people with Bipolar Disorder, run by University of Texas at Austin at 1 site in United States.
Trial summary
Investigating the application of transcranial infrared laser stimulation in individuals with bipolar disorder. Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Transcranial infrared laser stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2022to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to read, speak, and understand English.
- DSM-5 primary diagnosis of Bipolar Disorder type 1 or 2, by structured clinical interview (SCID-5).
- Montgomery-Asberg Depression Rating Scale score ≤ 12.
- Young Mania Rating Scale score ≤ 7.
- On at least one anti-mania agent at a therapeutic dose for 6 weeks.
- On stable doses of any standing psychotropics for 6 weeks.
- Any standing benzodiazepine to a maximum dose equivalent to 22.5 mg oxazepam or 7.5 mg diazepam per day.
Who cannot join
- Unable/unwilling to give informed consent.
- Diagnosed with current primary psychotic disorder (rather than bipolar disorder).
- Diagnosed with current manic/hypomanic or depressive episode.
- Moderate to severe substance use disorder within the past 6 months (except nicotine, caffeine, cannabis).
- Clinically defined major neurological disorder; including, but not limited to, seizure disorder and history of loss of consciousness due to head injury for greater than 10 minutes, or documented evidence of brain injury.
- Active suicidal intent/plan as detected on screening assessments, or in the investigator's opinion is likely to attempt suicide within the next 6 months.
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- Clinically significant unstable medical condition.
- If female: pregnant, not using medically acceptable birth control, or currently breastfeeding.
- Other conditions judged by the investigator that could prevent the participant from completing the study (such as but not limited to, significant physical disability (e.g., hearing/visual deficits) to perform a neutral memory task and/or neuropsychological test battery).
Trial locations and contacts
1 site in 1 country.
United States1 site
Dell Medical School at the University of Texas
Austin, Texas, 78712
About this study
Official title: Study Oxygenating the Brain With Laser Therapy to Increase Mental Functioning in Bipolar Disorder
Investigating the application of transcranial infrared laser stimulation in individuals with bipolar disorder.
Read the detailed description
Individuals with bipolar disorder have progressive cognitive decline with repeated mood episodes. This cognitive dysfunction is associated with decreased prefrontal cortex oxygen metabolism, involving cellular respiration in mitochondria. Transcranial infrared laser stimulation (TILS) of the prefrontal cortex uses a near-infrared wavelength of invisible light that penetrates the cortex and improves the ability of mitochondria to use oxygen in the brain. This new technology has been proven safe and is a non-pharmacologic, portable, convenient, and cost-effective form of modulating brain oxygenation using low-level infrared light. This treatment has shown great potential by improving cognitive and mood functioning in controlled human studies by photoactivation of the terminal enzyme in the mitochondrial respiratory chain called cytochrome oxidase (CCO). This mechanism results in unique functional benefits for neurons by stimulating oxygen metabolism. Since bipolar disorder may involve mitochondrial metabolic abnormalities, TILS is a potentially promising intervention. The investigators propose a study among individuals with bipolar disorder in order to 1) elucidate the physiological mechanisms of TILS using non-invasive neuroimaging methods (fNIRS, fMRI and ASL-MRI), and 2) investigate the benefits on people's cognitive functions and symptoms after TILS.
This is open label clinical trial with a single group assignment to treatment for individuals with bipolar disorder. The investigators will investigate if transcranial infrared laser stimulation (TILS) can upregulate brain activity and improve cognition.
- Conditions
- Bipolar Disorder
- Being tested
- Transcranial infrared laser stimulation
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial infrared laser stimulationDevice
non-invasive, non-pharmacologic photobiomodulation device
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Transcranial Infrared Laser Stimulation (TILS) | Experimental | Participants receive 10 minutes of TILS treatment to the right prefrontal cortex once a week for 6 weeks. TILS will use an FDA-cleared 1064-nm laser (CG-5000, Cell Gen Therapeutics, LLC, Dallas, TX). The irradiance will be 0.25 W/cm2, and fluence, 60 J/cm2. Receives: Device: Transcranial infrared laser stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Perfusion (Pre and Post Intervention)
Compare brain function as measured with arterial spin labelling, functional near infrared spectroscopy pre and post intervention
Measured: PRE = ~1 week before first intervention verses POST 1 = Immediately after 1st intervention/ POST 2 = after 6 weeks of TILS treatment
Changes in Resting State fMRI (Pre and Post Intervention)
Compare brain function as measured with resting state fMRI pre and post intervention
Measured: PRE = ~1 week before first intervention verses POST 1 = Immediately after 1st intervention/ POST 2 = after 6 weeks of TILS treatment
Changes in Resting State functional near-infrared spectroscopy (Pre and Post Intervention)
Compare brain function as measured with near-infrared spectroscopy pre and post intervention
Measured: PRE = ~1 week before first intervention verses POST 1 = Immediately after 1st intervention/ POST 2 = after 6 weeks of TILS treatment
Changes in task-based fMRI (Pre and Post Intervention): cognitive task with emotional distractors
Compare brain function as measured with near-infrared spectroscopy pre and post
Measured: PRE = ~1 week before first intervention verses POST 1 = Immediately after 1st intervention/ POST 2 = after 6 weeks of TILS treatment
Changes in task-based fMRI (Pre and Post Intervention): monetary reward and punishment
Compare brain function as measured with near-infrared spectroscopy pre and post
Measured: RE = ~1 week before first intervention verses POST 1 = Immediately after 1st intervention/ POST 2 = after 6 weeks of TILS treatment
Secondary outcomes (1)
Changes in Composite Score of Cognitive Function
Composite Score of cognitive function measures
Measured: PRE = ~ 1 week before first intervention verses POST after 6 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start1 May 2022 (estimated)
- Primary completion1 May 2023 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- Baszucki Brain Research Fund, Milken Institute
- Responsible party
- Principal investigator, Jorge Almeida, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05354895
- Sponsor's protocol ID
- 2019060106
- Status last verified
- Apr 2022
- First submitted
- 14 Apr 2022
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Barrett DW, Davis RE, Siegel-Ramsay JE, Bichlmeier A, Almeida JRC, Gonzalez-Lima F. Cognitive improvement and prefrontal network interactions in individuals with remitted bipolar disorder after transcranial infrared laser stimulation. Front Psychiatry. 2025 Jan 30;16:1547230. doi: 10.3389/fpsyt.2025.1547230. eCollection 2025.
PubMed 39950176
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Oxygenating the Brain With Laser Therapy to Increase Mental Functioning in Bipolar Disorder
- ClinicalTrials.gov ID
- NCT05354895
- Acronym / sponsor ID
- 2019060106
- Conditions
- Bipolar Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- Baszucki Brain Research Fund, Milken Institute
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 2 May 2022 (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.
Investigating the application of transcranial infrared laser stimulation in individuals with bipolar disorder.
Detailed description
Individuals with bipolar disorder have progressive cognitive decline with repeated mood episodes. This cognitive dysfunction is associated with decreased prefrontal cortex oxygen metabolism, involving cellular respiration in mitochondria. Transcranial infrared laser stimulation (TILS) of the prefrontal cortex uses a near-infrared wavelength of invisible light that penetrates the cortex and improves the ability of mitochondria to use oxygen in the brain. This new technology has been proven safe and is a non-pharmacologic, portable, convenient, and cost-effective form of modulating brain oxygenation using low-level infrared light. This treatment has shown great potential by improving cognitive and mood functioning in controlled human studies by photoactivation of the terminal enzyme in the mitochondrial respiratory chain called cytochrome oxidase (CCO). This mechanism results in unique functional benefits for neurons by stimulating oxygen metabolism. Since bipolar disorder may involve mitochondrial metabolic abnormalities, TILS is a potentially promising intervention. The investigators propose a study among individuals with bipolar disorder in order to 1) elucidate the physiological mechanisms of TILS using non-invasive neuroimaging methods (fNIRS, fMRI and ASL-MRI), and 2) investigate the benefits on people's cognitive functions and symptoms after TILS.
This is open label clinical trial with a single group assignment to treatment for individuals with bipolar disorder. The investigators will investigate if transcranial infrared laser stimulation (TILS) can upregulate brain activity and improve cognition.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention: Transcranial Infrared Laser Stimulation (TILS) | Experimental | Device: Transcranial infrared laser stimulationParticipants receive 10 minutes of TILS treatment to the right prefrontal cortex once a week for 6 weeks. TILS will use an FDA-cleared 1064-nm laser (CG-5000, Cell Gen Therapeutics, LLC, Dallas, TX). The irradiance will be 0.25 W/cm2, and fluence, 60 J/cm2. |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able to read, speak, and understand English.
- DSM-5 primary diagnosis of Bipolar Disorder type 1 or 2, by structured clinical interview (SCID-5).
- Montgomery-Asberg Depression Rating Scale score ≤ 12.
- Young Mania Rating Scale score ≤ 7.
- On at least one anti-mania agent at a therapeutic dose for 6 weeks.
Key exclusion criteria (9 listed)
- Unable/unwilling to give informed consent.
- Diagnosed with current primary psychotic disorder (rather than bipolar disorder).
- Diagnosed with current manic/hypomanic or depressive episode.
- Moderate to severe substance use disorder within the past 6 months (except nicotine, caffeine, cannabis).
- Clinically defined major neurological disorder; including, but not limited to, seizure disorder and history of loss of consciousness due to head injury for greater than 10 minutes, or documented evidence of brain injury.
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 |
|---|---|---|
| Transcranial infrared laser stimulationnon-invasive, non-pharmacologic photobiomodulation device | Device | Intervention: Transcranial Infrared Laser Stimulation (TILS) |
Primary outcome
Changes in Perfusion (Pre and Post Intervention)
Time frame: PRE = ~1 week before first intervention verses POST 1 = Immediately after 1st intervention/ POST 2 = after 6 weeks of TILS treatment
Compare brain function as measured with arterial spin labelling, functional near infrared spectroscopy pre and post intervention
Changes in Resting State fMRI (Pre and Post Intervention)
Time frame: PRE = ~1 week before first intervention verses POST 1 = Immediately after 1st intervention/ POST 2 = after 6 weeks of TILS treatment
Compare brain function as measured with resting state fMRI pre and post intervention
Changes in Resting State functional near-infrared spectroscopy (Pre and Post Intervention)
Time frame: PRE = ~1 week before first intervention verses POST 1 = Immediately after 1st intervention/ POST 2 = after 6 weeks of TILS treatment
Compare brain function as measured with near-infrared spectroscopy pre and post intervention
Changes in task-based fMRI (Pre and Post Intervention): cognitive task with emotional distractors
Time frame: PRE = ~1 week before first intervention verses POST 1 = Immediately after 1st intervention/ POST 2 = after 6 weeks of TILS treatment
Compare brain function as measured with near-infrared spectroscopy pre and post
Changes in task-based fMRI (Pre and Post Intervention): monetary reward and punishment
Time frame: RE = ~1 week before first intervention verses POST 1 = Immediately after 1st intervention/ POST 2 = after 6 weeks of TILS treatment
Compare brain function as measured with near-infrared spectroscopy pre and post
1 secondary outcome
Changes in Composite Score of Cognitive Function
Time frame: PRE = ~ 1 week before first intervention verses POST after 6 weeks of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Derived from this study: PubMed 39950176Barrett DW, Davis RE, Siegel-Ramsay JE, Bichlmeier A, Almeida JRC, Gonzalez-Lima F. Cognitive improvement and prefrontal network interactions in individuals with remitted bipolar disorder after transcranial infrared laser stimulation. Front Psychiatry. 2025 Jan 30;16:1547230. doi: 10.3389/fpsyt.2025.1547230. eCollection 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial infrared laser stimulation in people with Bipolar Disorder, run by University of Texas at Austin 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 7 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 2 May 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jorge Almeida, M.D., PhD. (512-495-5338, jorge.almeida@austin.utexas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Perfusion (Pre and Post Intervention) (time frame: PRE = ~1 week before first intervention verses POST 1 = Immediately after 1st intervention/ POST 2 = after 6 weeks of TILS treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05354895, which also lists 1 linked publication.
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 2 May 2022; AzTrials last refreshed its copy on 28 Oct 2026.