Oxygenating the Brain With Laser Therapy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Bipolar Disorder
• Intervention / Treatment: Device: Transcranial infrared laser stimulation

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 Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jorge Almeida, M.D., PhD.; Phone Number: 512-495-5338; Email: jorge.almeida@austin.utexas.edu
• Study Contact Backup: Name: Jennifer Siegel-Ramsay, PhD; Phone Number: 512-351-5258; Email: jennifer.siegelramsay@austin.utexas.edu

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78712
      • Dell Medical School at the University of Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion

1. Able to read, speak, and understand English.
2. DSM-5 primary diagnosis of Bipolar Disorder type 1 or 2, by structured clinical interview (SCID-5).
3. Montgomery-Asberg Depression Rating Scale score ≤ 12.
4. Young Mania Rating Scale score ≤ 7.
5. On at least one anti-mania agent at a therapeutic dose for 6 weeks.
6. On stable doses of any standing psychotropics for 6 weeks.
7. Any standing benzodiazepine to a maximum dose equivalent to 22.5 mg oxazepam or 7.5 mg diazepam per day.

Exclusion Criteria:

1. Unable/unwilling to give informed consent.
2. Diagnosed with current primary psychotic disorder (rather than bipolar disorder).
3. Diagnosed with current manic/hypomanic or depressive episode.
4. Moderate to severe substance use disorder within the past 6 months (except nicotine, caffeine, cannabis).
5. 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.
6. 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.
7. Clinically significant unstable medical condition.
8. If female: pregnant, not using medically acceptable birth control, or currently breastfeeding.
9. 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention: Transcranial Infrared Laser Stimulation (TILS); 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; non-invasive, non-pharmacologic photobiomodulation device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Composite Score of Cognitive Function	Composite Score of cognitive function measures	PRE = ~ 1 week before first intervention verses POST after 6 weeks of intervention

Collaborators and Investigators

• Sponsor: University of Texas at Austin
• Collaborators: Milken Institute; Baszucki Brain Research Fund

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2022
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): May 1, 2024

Study Registration Dates

• First Submitted: April 14, 2022
• First Submitted That Met QC Criteria: April 26, 2022
• First Posted (Actual): May 2, 2022

Study Record Updates

• Last Update Posted (Actual): May 2, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Bipolar and Related Disorders; Bipolar Disorder
• Other Study ID Numbers: 2019060106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes