Clinical trial NCT05752422: Transcranial Photobiomodulation for Adult ADHD
Official title: Transcranial Photobiomodulation for Adult ADHD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ADHD
Keywords: ADHD
Attention
Photobiomodulation
Lead sponsor: CNS Onlus
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to assess the behavioral as well cognitive changes in ADHD symptoms in terms of improvement of inhibitory control and attention in adults with ADHD

Detailed description: This study is a randomized double blind trial. After selection and enrollment, participants will be screened at baseline with a complete diagnostic and clinical assessment, and randomized to receive active or placebo t-PBM.

At visit 1 patients will undergo a (pre-treatment) neuropsychological testing followed by the first t-PBM session. After the first t-PBM session, the patients will undergo another (post-treatment) neuropsychological testing. After visit 1, which includes the first treatment, patients will receive additional 4 weeks of t-PBM treatments. After the last treatment, patients will come to clinic for undergo a clinical and neuropsychological assessment (visit 2). After the visit 2, patients will receive other 4 weeks of t-PBM treatments. After the last t-PBM treatment session, patients will come to clinic to undergo the final clinical and neuropsychological assessment (visit 3).

At the visits 1, 2 and 3 patients will be asked if they believe they received active or sham treatment.

Eligibility criteria: Inclusion Criteria:

• subjects diagnosed with ADHD

Exclusion Criteria:

* schizophrenia or other psychosis
* current acute depressive episode
* bipolar disorder with current manic or depressive episode
* active substance use disorder
* autism
* dementia.

Primary outcomes:
measure: 4-weeks effect of t-PBM
timeFrame: 1 month
measure: 4-weeks effect of t-PBM
timeFrame: 1 month
measure: 4-weeks effect of t-PBM
timeFrame: 1 month
measure: 8-weeks effect of t-PBM
timeFrame: 2 months
measure: 8-weeks effect of t-PBM
timeFrame: 2 months
measure: 8-weeks effect of t-PBM
timeFrame: 2 months
measure: 8-weeks effect of t-PBM
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: American Psychiatric Association, 2013. Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). Diagnostic Stat. Man. Ment. Disord. 4th Ed. TR. 280. Caldieraro, M. A., & Cassano, P. (2019). Journal of Affective Disorders Transcranial and systemic photobiomodulation for major depressive disorder : A systematic review of efficacy , tolerability and biological mechanisms. Journal of Affective Disorders, 243(May 2018), 262-273. https://doi.org/10.1016/j.jad.2018.09.048 Hwang, J, Castelli, D. M, Gonzalez-Lima, F, 2016. Cognitive enhancement by transcranial laser stimulation and acute aerobic exercise. Lasers in Medical Science 31-6, 1151-1160 Barrett, D. W. (2013). Transcranial Infrared Laser Stimulation Produces Beneficial Cognitive And Emotional Effects In Humans. Neuroscience, 230, 13-23. https://doi.org/10.1016/j.neuroscience.2012.11.016