Transcranial Photobiomodulation for Adult ADHD

Study Overview
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Brief Summary
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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
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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.

Official Title
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Transcranial Photobiomodulation for Adult ADHD

Conditions
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ADHD

Intervention / Treatment
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* Device: Niraxx G1 Headband Device including sham


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active transcranial Photobiomodulation (t-PBM)<br>Active t-PBM will be delivered to the forehead using the Niraxx Smart Headband (gen 1). Daily treatments of 40 min | Device: Niraxx G1 Headband Device including sham<br>* Exploring effect of active t-PBM delivered by Niraxx G1 Headband versus sham condition<br>|
| Sham Comparator: Sham t-PBM<br>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. | Device: Niraxx G1 Headband Device including sham<br>* Exploring effect of active t-PBM delivered by Niraxx G1 Headband versus sham condition<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, Attention, Photobiomodulation