Transcranial Photobiomodulation for Adult ADHD

NCT ID: NCT05752422

Last Updated: 2023-03-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-15
• Study Completion Date: 2024-06-30

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.

Conditions

ADHD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active transcranial Photobiomodulation (t-PBM)

Active t-PBM will be delivered to the forehead using the Niraxx Smart Headband (gen 1). Daily treatments of 40 min

Group Type: EXPERIMENTAL

Niraxx G1 Headband Device including sham

Intervention Type: DEVICE

Exploring effect of active t-PBM delivered by Niraxx G1 Headband versus sham condition

Sham t-PBM

To the subjects belonging to the sham arm the sham treatment sessions will be performed using the same device, during the same time but the device will not be turned on.

Group Type: SHAM_COMPARATOR

Niraxx G1 Headband Device including sham

Intervention Type: DEVICE

Exploring effect of active t-PBM delivered by Niraxx G1 Headband versus sham condition

Interventions

Niraxx G1 Headband Device including sham

Exploring effect of active t-PBM delivered by Niraxx G1 Headband versus sham condition

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CNS Onlus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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

Reference Type: BACKGROUND

Other Identifiers

CNS11082019

Identifier Type: -

Identifier Source: org_study_id