Status:
UNKNOWN
Oxygenating the Brain With Laser Therapy
Lead Sponsor:
University of Texas at Austin
Collaborating Sponsors:
Baszucki Brain Research Fund
Milken Institute
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18-78 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2024
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05354895
Start Date
May 1 2022
End Date
May 1 2024
Last Update
May 2 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Dell Medical School at the University of Texas
Austin, Texas, United States, 78712