Transcranial Photobiomodulation for Adult ADHD

Not Applicable

Not yet recruiting

• Conditions: ADHD
• Interventions: Device: Niraxx G1 Headband Device including sham

• Registration Number: NCT05752422
• Lead Sponsor: CNS Onlus

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.

Study Timeline

• Study First Submitted: 2019-11-11
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-21
• Last Update Submitted: 2023-02-21
• Study First Posted: 2023-03-02
• Last Update Posted: 2023-03-02
• Study Start: 2023-06-15
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham t-PBM	Niraxx G1 Headband Device including sham	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.
Active transcranial Photobiomodulation (t-PBM)	Niraxx G1 Headband Device including sham	Active t-PBM will be delivered to the forehead using the Niraxx Smart Headband (gen 1). Daily treatments of 40 min

Primary Outcome Measures

Name	Time	Method
8-weeks effect of t-PBM	2 months	To assess the clinical changes of 8 weeks PBM treatment in terms of reduction of ADHD symptoms severity
4-weeks effect of t-PBM	1 month	To assess the clinical changes of 4 weeks PBM treatment in terms of reduction of ADHD symptoms severity