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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
CNS Onlus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ADHD focused on measuring ADHD, Attention, Photobiomodulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    November 11, 2019
    Last Updated
    February 21, 2023
    Sponsor
    CNS Onlus
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    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
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    Transcranial Photobiomodulation for Adult ADHD

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