Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- ADHD
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2023to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subjects diagnosed with ADHD
Who cannot join
- schizophrenia or other psychosis
- current acute depressive episode
- bipolar disorder with current manic or depressive episode
- active substance use disorder
- autism
- dementia.
About this study
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
Read the 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.
- Conditions
- ADHD
- Being tested
- Niraxx G1 Headband Device including sham
- Keywords
- ADHD, Attention, Photobiomodulation
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Niraxx G1 Headband Device including shamDevice
Exploring effect of active t-PBM delivered by Niraxx G1 Headband versus sham condition
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: Niraxx G1 Headband Device including sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start15 Jun 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CNS Onlus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05752422
- Sponsor's protocol ID
- CNS11082019
- Status last verified
- Feb 2023
- First submitted
- 11 Nov 2019
- Last updated
- 2 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30248638
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Photobiomodulation for Adult ADHD
- ClinicalTrials.gov ID
- NCT05752422
- Acronym / sponsor ID
- CNS11082019
- Conditions
- ADHD
- Keywords
- ADHD, Attention, Photobiomodulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- CNS OnlusUniversity, hospital or other
- Study start
- 15 Jun 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 2 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active transcranial Photobiomodulation (t-PBM) | Experimental | Device: Niraxx G1 Headband Device including shamActive t-PBM will be delivered to the forehead using the Niraxx Smart Headband (gen 1). Daily treatments of 40 min |
| Sham t-PBM | Sham comparator | Device: Niraxx G1 Headband Device including shamTo 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- subjects diagnosed with ADHD
Key exclusion criteria (6 listed)
- schizophrenia or other psychosis
- current acute depressive episode
- bipolar disorder with current manic or depressive episode
- active substance use disorder
- autism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Niraxx G1 Headband Device including shamExploring effect of active t-PBM delivered by Niraxx G1 Headband versus sham condition | Device | Active transcranial Photobiomodulation (t-PBM), Sham t-PBM |
Primary outcome
4-weeks effect of t-PBM
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 2 months
To assess the clinical changes of 8 weeks PBM treatment in terms of reduction of ADHD symptoms severity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Background: PubMed 30248638Caldieraro 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study of ADHD, run by CNS Onlus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
4-weeks effect of t-PBM (time frame: 1 month). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05752422, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2023.