Back to resultsOxygenating the Brain With Laser Therapy
Primary Purpose
Bipolar Disorder
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial infrared laser stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder
Eligibility Criteria
Inclusion
- 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.
Exclusion Criteria:
- 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).
Sites / Locations
- Dell Medical School at the University of Texas
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention: Transcranial Infrared Laser Stimulation (TILS)
Arm Description
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.
Outcomes
Primary Outcome Measures
Changes in Perfusion (Pre and Post Intervention)
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)
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)
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
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
Compare brain function as measured with near-infrared spectroscopy pre and post
Secondary Outcome Measures
Changes in Composite Score of Cognitive Function
Composite Score of cognitive function measures
Full Information
NCT ID
NCT05354895
First Posted
April 14, 2022
Last Updated
April 26, 2022
Sponsor
University of Texas at Austin
Collaborators
Baszucki Brain Research Fund, Milken Institute
1. Study Identification
Unique Protocol Identification Number
NCT05354895
Brief Title
Oxygenating the Brain With Laser Therapy
Official Title
Study Oxygenating the Brain With Laser Therapy to Increase Mental Functioning in Bipolar Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2022 (Anticipated)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin
Collaborators
Baszucki Brain Research Fund, Milken Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention: Transcranial Infrared Laser Stimulation (TILS)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transcranial infrared laser stimulation
Intervention Description
non-invasive, non-pharmacologic photobiomodulation device
Primary Outcome Measure Information:
Title
Changes in Perfusion (Pre and Post Intervention)
Description
Compare brain function as measured with arterial spin labelling, 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
Title
Changes in Resting State fMRI (Pre and Post Intervention)
Description
Compare brain function as measured with 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
Title
Changes in Resting State functional near-infrared spectroscopy (Pre and Post Intervention)
Description
Compare brain function as measured with 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
Title
Changes in task-based fMRI (Pre and Post Intervention): cognitive task with emotional distractors
Description
Compare brain function as measured with near-infrared spectroscopy pre and post
Time Frame
PRE = ~1 week before first intervention verses POST 1 = Immediately after 1st intervention/ POST 2 = after 6 weeks of TILS treatment
Title
Changes in task-based fMRI (Pre and Post Intervention): monetary reward and punishment
Description
Compare brain function as measured with near-infrared spectroscopy pre and post
Time Frame
RE = ~1 week before first intervention verses POST 1 = Immediately after 1st intervention/ POST 2 = after 6 weeks of TILS treatment
Secondary Outcome Measure Information:
Title
Changes in Composite Score of Cognitive Function
Description
Composite Score of cognitive function measures
Time Frame
PRE = ~ 1 week before first intervention verses POST after 6 weeks of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion
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.
Exclusion Criteria:
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jorge Almeida, M.D., PhD.
Phone
512-495-5338
Email
jorge.almeida@austin.utexas.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Siegel-Ramsay, PhD
Phone
512-351-5258
Email
jennifer.siegelramsay@austin.utexas.edu
Facility Information:
Facility Name
Dell Medical School at the University of Texas
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Oxygenating the Brain With Laser Therapy
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