Transcranial Photobiomodulation in Anxiety Disorders
Part of paid clinical trials in Austin, Texas.
- Sponsor
- Francisco Gonzalez-Lima, PhD
- Study ID
- NCT07133893
- Status
- Recruiting
Conditions
- Symptoms of Anxiety
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 100 Years
- Healthy Volunteers
- Accepted
Interventions
- Attention bias assessment and modification — BEHAVIORALAttention bias assessment and modification involve two versions of the dot-probe task. These tasks are based on the premise that repeated attention shifts can retrain attentional biases, with the expectation that reducing attentional bias toward threats will alleviate sub-clinical anxiety symptoms.
- Transcranial photobiomodulation — DEVICEParticipants will receive near-infrared light at 1064 nanometers to the right side of the forehead for 8 minutes. The investigators have introduced this form of transcranial photobiomodulation (tPBM) as a means of human cognitive enhancement, and as an adjunct for attention bias modification for the reduction of symptoms of depression. In the present study, the investigators wish to extend these findings to the use of attention bias modification for the reduction of sub-clinical anxiety.
Study Details
The investigators have previously shown that safe, non-invasive methods of brain stimulation such as the administration of transcranial infrared light can result in improvements to cognition and emotion. The investigators hypothesize that transcranial photobiomodulation (tPBM) can be used in conjunction with attention bias assessment and modification to reduce anxiety symptoms in individuals with sub-clinical anxiety.
Key Dates
- Start date
- Sep 1, 2025
- Status verified
- May 2026
- Primary completion
- Sep 30, 2027
- Completion
- Sep 30, 2028
Study Design
- Enrollment
- 280 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Arm 1: attention bias assessment (ABA), transcranial photobiomodulation (tPBM)Participants will receive attention bias assessment (ABA) in conjunction with active transcranial photobiomodulation (tPBM) treatment to the forehead.
- Sham Comparator: Arm 2: attention bias assessment (ABA), sham tPBMParticipants will receive attention bias assessment (ABA) in conjunction with sham (laser light off) transcranial photobiomodulation (tPBM) treatment to the forehead.
- Active Comparator: Arm 3: attention bias assessment and modification (ABA/ABM), transcranial photobiomodulation (tPBM)Participants will receive attention bias assessment plus attention bias modification (ABA/ABM) in conjunction with active transcranial photobiomodulation (tPBM) treatment to the forehead.
- Sham Comparator: Arm 4: attention bias assessment and modification (ABA/ABM), sham tPBMParticipants will receive attention bias assessment plus attention bias modification (ABA/ABM) in conjunction with sham (laser light off) transcranial photobiomodulation (tPBM) treatment to the forehead.
Primary Outcome Measure
Composite cognitive score in the dot-probe task [ Time Frame: Visit 1 (baseline), Visit 2 (three days after Visit 1), Visit 3 (1 week after Visit 2) ]
Central Contacts
- Francisco Gonzalez-Lima, Ph.D.512-537-5257
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The University of Texas at Austin | Austin | Texas | 78712 | Francisco Gonzalez-Lima, Ph.D. (PRINCIPAL_INVESTIGATOR) |
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