Transcranial Photobiomodulation for Adult ADHD
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Active transcranial Photobiomodulation (t-PBM) 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
Exploring effect of active t-PBM delivered by Niraxx G1 Headband versus sham condition
|
| Sham Comparator: Sham t-PBM 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
|
Outcome Measures
Primary Outcome Measures
- 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
- 4-weeks effect of t-PBM [1 month]
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
- 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
- 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
- 8-weeks effect of t-PBM [2 months]
To assess the behavioral changes of 8 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 cognitive changes of 8 weeks PBM treatment in terms of normalization of intra-individual reaction time variability, as assessed through the Stop Signal Task
- 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
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- CNS Onlus
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- CNS11082019