Oxygenating the Brain With Laser Therapy

NCT05354895 | Unknown FDA Device

• 1 other identifier: 2019060106
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Investigating the application of transcranial infrared laser stimulation in individuals with bipolar disorder.

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (5)

• Changes in Perfusion (Pre and Post Intervention)

  Compare brain function as measured with arterial spin labelling, functional near infrared spectroscopy pre and post intervention

  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

  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

  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

  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

  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

  PRE = ~ 1 week before first intervention verses POST after 6 weeks of intervention

Study Arms (1)

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.

Device: Transcranial infrared laser stimulation

Interventions

Transcranial infrared laser stimulation DEVICE

non-invasive, non-pharmacologic photobiomodulation device

Intervention: Transcranial Infrared Laser Stimulation (TILS)

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• University of Texas at Austin: lead
• Baszucki Brain Research Fund: collaborator
• Milken Institute: collaborator

Study Sites (1)

Dell Medical School at the University of Texas

Austin, Texas, 78712, United States

Location

Related Publications (1)

• 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.

  PMID: 39950176 DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Central Study Contacts

Jorge Almeida, M.D., PhD.

CONTACT

512-495-5338; jorge.almeida@austin.utexas.edu

Jennifer Siegel-Ramsay, PhD

CONTACT

512-351-5258; jennifer.siegelramsay@austin.utexas.edu

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: Director, Bipolar Disorder Center | Associate Professor of Psychiatry

Study Record Dates

• First Submitted: April 14, 2022
• First Posted: May 2, 2022
• Study Start: May 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2024
• Last Updated: May 2, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)