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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
32
Exploring effect of active t-PBM delivered by Niraxx G1 Headband versus sham condition
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 2 months
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