NCT05752422

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2019

Completed
3.3 years until next milestone

First Posted

Study publicly available on registry

March 2, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

June 15, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

March 2, 2023

Status Verified

February 1, 2023

Enrollment Period

12 months

First QC Date

November 11, 2019

Last Update Submit

February 21, 2023

Conditions

ADHD

Keywords

ADHDAttentionPhotobiomodulation

Outcome Measures

Primary Outcomes (7)

  • 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

    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

    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

    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

    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

    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

    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

    2 months

Study Arms (2)

Active transcranial Photobiomodulation (t-PBM)

EXPERIMENTAL

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

Sham t-PBM

SHAM COMPARATOR

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

Interventions

Niraxx G1 Headband Device including shamDEVICE

Exploring effect of active t-PBM delivered by Niraxx G1 Headband versus sham condition

Active transcranial Photobiomodulation (t-PBM)Sham t-PBM

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • subjects diagnosed with ADHD

You may not qualify if:

  • schizophrenia or other psychosis
  • current acute depressive episode
  • bipolar disorder with current manic or depressive episode
  • active substance use disorder
  • autism
  • dementia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • American Psychiatric Association, 2013. Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). Diagnostic Stat. Man. Ment. Disord. 4th Ed. TR. 280. Caldieraro, M. A., & Cassano, P. (2019). Journal of Affective Disorders Transcranial and systemic photobiomodulation for major depressive disorder : A systematic review of efficacy , tolerability and biological mechanisms. Journal of Affective Disorders, 243(May 2018), 262-273. https://doi.org/10.1016/j.jad.2018.09.048 Hwang, J, Castelli, D. M, Gonzalez-Lima, F, 2016. Cognitive enhancement by transcranial laser stimulation and acute aerobic exercise. Lasers in Medical Science 31-6, 1151-1160 Barrett, D. W. (2013). Transcranial Infrared Laser Stimulation Produces Beneficial Cognitive And Emotional Effects In Humans. Neuroscience, 230, 13-23. https://doi.org/10.1016/j.neuroscience.2012.11.016

    BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2019

First Posted

March 2, 2023

Study Start

June 15, 2023

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

March 2, 2023

Record last verified: 2023-02