ADHD
Conditions
Keywords
ADHD, Attention, Photobiomodulation
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.
Interventions
DEVICENiraxx G1 Headband Device including sham
Exploring effect of active t-PBM delivered by Niraxx G1 Headband versus sham condition
Sponsors
CNS Onlus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 4-weeks effect of t-PBM | 1 month | To assess the effects of 4 weeks PBM treatment in terms of improvement of inhibitory control, as assessed through the Stop Signal Task |
| 8-weeks effect of t-PBM | 2 months | 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 |
Outcome results
None listed