Transcranial Photobiomodulation for Adult ADHD
Primary Purpose
ADHD
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Niraxx G1 Headband Device including sham
Sponsored by
About this trial
This is an interventional treatment trial for ADHD focused on measuring ADHD, Attention, Photobiomodulation
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Active transcranial Photobiomodulation (t-PBM)
Sham t-PBM
Arm Description
Active t-PBM will be delivered to the forehead using the Niraxx Smart Headband (gen 1). Daily treatments of 40 min
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.
Outcomes
Primary Outcome Measures
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
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
4-weeks effect of t-PBM
To assess the clinical changes of 4 weeks PBM treatment in terms of reduction of ADHD symptoms severity
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
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
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
8-weeks effect of t-PBM
To assess the clinical changes of 8 weeks PBM treatment in terms of reduction of ADHD symptoms severity
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05752422
Brief Title
Transcranial Photobiomodulation for Adult ADHD
Official Title
Transcranial Photobiomodulation for Adult ADHD
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 15, 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CNS Onlus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD
Keywords
ADHD, Attention, Photobiomodulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active transcranial Photobiomodulation (t-PBM)
Arm Type
Experimental
Arm Description
Active t-PBM will be delivered to the forehead using the Niraxx Smart Headband (gen 1). Daily treatments of 40 min
Arm Title
Sham t-PBM
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Niraxx G1 Headband Device including sham
Intervention Description
Exploring effect of active t-PBM delivered by Niraxx G1 Headband versus sham condition
Primary Outcome Measure Information:
Title
4-weeks effect of t-PBM
Description
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
Title
4-weeks effect of t-PBM
Description
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
Title
4-weeks effect of t-PBM
Description
To assess the clinical changes of 4 weeks PBM treatment in terms of reduction of ADHD symptoms severity
Time Frame
1 month
Title
8-weeks effect of t-PBM
Description
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
Title
8-weeks effect of t-PBM
Description
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
Title
8-weeks effect of t-PBM
Description
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
Title
8-weeks effect of t-PBM
Description
To assess the clinical changes of 8 weeks PBM treatment in terms of reduction of ADHD symptoms severity
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
12. IPD Sharing Statement
Citations:
PubMed Identifier
30248638
Citation
Caldieraro MA, Cassano P. Transcranial and systemic photobiomodulation for major depressive disorder: A systematic review of efficacy, tolerability and biological mechanisms. J Affect Disord. 2019 Jan 15;243:262-273. doi: 10.1016/j.jad.2018.09.048. Epub 2018 Sep 17.
Results Reference
background
Learn more about this trial
Transcranial Photobiomodulation for Adult ADHD
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