NCT05752422

Transcranial Photobiomodulation for Adult ADHD

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: CNS Onlus · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Niraxx G1 Headband Device including sham	Exploring effect of active t-PBM delivered by Niraxx G1 Headband versus sham condition

Timeline

• Start date: 2023-06-15
• Primary completion: 2024-06-01
• Completion: 2024-06-01
• First posted: 2023-03-02
• Last updated: 2023-03-02