Transcranial Photobiomodulation for Adult ADHD

CNS Onlus

Status: Not yet enrolling

Conditions: ADHD

Treatments: Device: Niraxx G1 Headband Device including sham

Study type: Interventional

Funder types: Other

Identifiers

NCT05752422

CNS11082019

Details and patient eligibility

About

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

Full 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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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32 participants in 2 patient groups

Active transcranial Photobiomodulation (t-PBM)

Experimental group

Description:

Active t-PBM will be delivered to the forehead using the Niraxx Smart Headband (gen 1). Daily treatments of 40 min

Treatment:

Device: Niraxx G1 Headband Device including sham

Sham t-PBM

Sham Comparator group

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.

Treatment:

Device: Niraxx G1 Headband Device including sham