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Device
Laser Therapy for Bipolar Disorder
N/A
Waitlist Available
Research Sponsored by University of Texas at Austin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Any standing benzodiazepine to a maximum dose equivalent to 22.5 mg oxazepam or 7.5 mg diazepam per day
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre = ~ 1 week before first intervention verses post after 6 weeks of intervention
Awards & highlights
Study Summary
This trial is testing whether transcranial infrared laser stimulation can help improve symptoms in people with bipolar disorder.
Who is the study for?
This trial is for English-speaking individuals with Bipolar Disorder (type 1 or 2), not currently in a severe episode, and on stable medication. It excludes those who are pregnant, not using birth control, breastfeeding, have major neurological disorders or substance abuse issues, or are at risk of suicide.Check my eligibility
What is being tested?
The study tests transcranial infrared laser stimulation on people with bipolar disorder to see if it can help oxygenate the brain. Participants will undergo this non-invasive treatment while their condition is monitored.See study design
What are the potential side effects?
Potential side effects aren't specified but as a non-invasive technique involving light therapy over the scalp, risks may be minimal compared to drug treatments. Any discomfort or unexpected reactions should be reported.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I take a low dose of anxiety or sleep medication daily.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre = ~1 week before first intervention verses post 1 = immediately after 1st intervention/ post 2 = after 6 weeks of tils treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre = ~1 week before first intervention verses post 1 = immediately after 1st intervention/ post 2 = after 6 weeks of tils treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in Perfusion (Pre and Post Intervention)
Changes in Resting State fMRI (Pre and Post Intervention)
Changes in Resting State functional near-infrared spectroscopy (Pre and Post Intervention)
+2 moreSecondary outcome measures
Changes in Composite Score of Cognitive Function
Trial Design
1Treatment groups
Experimental Treatment
Group I: Intervention: Transcranial Infrared Laser Stimulation (TILS)Experimental Treatment1 Intervention
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.
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Who is running the clinical trial?
University of Texas at AustinLead Sponsor
353 Previous Clinical Trials
81,208 Total Patients Enrolled
5 Trials studying Bipolar Disorder
290 Patients Enrolled for Bipolar Disorder
Baszucki Brain Research FundOTHER
6 Previous Clinical Trials
279 Total Patients Enrolled
5 Trials studying Bipolar Disorder
269 Patients Enrolled for Bipolar Disorder
Milken InstituteOTHER
7 Previous Clinical Trials
251 Total Patients Enrolled
6 Trials studying Bipolar Disorder
245 Patients Enrolled for Bipolar Disorder
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a major neurological disorder or a history of significant brain injury.I have been on medication for mania for at least 6 weeks.I take a low dose of anxiety or sleep medication daily.I am currently experiencing a manic, hypomanic, or depressive episode.I have been on the same mental health medication dose for 6 weeks.I have been diagnosed with a primary psychotic disorder, not bipolar disorder.I am not pregnant, using birth control, or breastfeeding.I do not have any unstable health conditions.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention: Transcranial Infrared Laser Stimulation (TILS)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are elderly individuals eligible for enrollment in this experiment?
"To be accepted into the trial, participants must fall between 18 and 78 years old. Furthermore, there are 21 clinical trials available for minors and 114 for seniors."
Answered by AI
Under what qualifications can a person enroll in this study?
"To be eligible for this trial, applicants must have a diagnosis of manic disorder and lie between 18 to 78 years old. A total of 36 participants will be accepted into the study."
Answered by AI
Are there available spots remaining for potential participants in this clinical trial?
"The information from clinicaltrials.gov indicates that recruitment for this trial is currently paused, as the last update was on April 26th 2022. Despite this inactivity, there are 154 other trials inviting participants right now."
Answered by AI
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