An interventional study of Niraxx G1 Headband Device including sham in ADHD, sponsored by CNS Onlus. Status unknown. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-03-02.
Sponsored by CNS Onlus · Not applicable, Interventional, and Treatment
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.
1,514 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 255 are open to participants now.
This study's planned enrollment of 32 is below the median of 72 across 1,207 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
Browse Attention Deficit Disorder with Hyperactivity studies →CNS Onlus is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
No study locations are listed for this record.
This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Attention Deficit Disorder with Hyperactivity→
CNS Onlus