Transcranial Photobiomodulation for Adult ADHD

ADHD Clinical Trial

Official title:

Transcranial Photobiomodulation for Adult ADHD

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05752422
• Other study ID #: CNS11082019
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2023
• Est. completion date: June 2024

Study information

• Verified date: February 2023
• Source: CNS Onlus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• ADHD

Intervention

Device:
• Niraxx G1 Headband Device including sham
Exploring effect of active t-PBM delivered by Niraxx G1 Headband versus sham condition

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CNS Onlus

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	4-weeks effect of t-PBM	To assess the effects of 4 weeks PBM treatment in terms of improvement of inhibitory control, as assessed through the Stop Signal Task	1 month
Primary	4-weeks effect of t-PBM	To assess the cognitive changes of 4 weeks PBM treatment in terms of improvement of normalization of intra-individual reaction time variability as assessed through the Stop Signal Task	1 month
Primary	4-weeks effect of t-PBM	To assess the clinical changes of 4 weeks PBM treatment in terms of reduction of ADHD symptoms severity	1 month
Primary	8-weeks effect of t-PBM	To assess the behavioral/cognitive and clinical changes of 8 weeks PBM treatment in terms of improvement of inhibitory control and normalization of intra-individual reaction time variability, as assessed through the Stop Signal Task, as well reduction of ADHD symptoms severity	2 months
Primary	8-weeks effect of t-PBM	To assess the behavioral changes of 8 weeks PBM treatment in terms of improvement of inhibitory control, as assessed through the Stop Signal Task	2 months
Primary	8-weeks effect of t-PBM	To assess the cognitive changes of 8 weeks PBM treatment in terms of normalization of intra-individual reaction time variability, as assessed through the Stop Signal Task	2 months
Primary	8-weeks effect of t-PBM	To assess the clinical changes of 8 weeks PBM treatment in terms of reduction of ADHD symptoms severity	2 months