NIRS Neurofeedback as a Treatment for Attention Deficit Hyperactivity Disorder

Study Overview
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Brief Summary
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The investigators therefore propose a pilot study to establish the effectiveness of NIRS Neurofeedback training in reducing the intensity of ADHD symptom expression on children, improvement of the cognitive and global functions associated with ADHD, effects on cerebral blood perfusion in the cortex and safety plus possible unknown side-effects.

Detailed Description
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Background: Attention Deficit Hyperactivity Disorder (ADHD) is a mental condition originating in childhood, characterized by symptoms of lack attention, hyperactivity and impulsiveness associated with significant functional impairment. Currently, the use of neurofeedback as a non-drug alternative technique for treatment of ADHD has increasingly spread among the clinical and academic fields, producing relevant findings with regard to its effectiveness. The SCP Neurofeedback and EEG Neurofeedback have been the most studied techniques until the moment, with equipments and systems made available to the market at prices between US$ 10.000 and US$ 20.000, while NIRS Neurofeedback equipments can be found for around US$ 2.000. Due to the low cost of the necessary equipment's and easy access to the technology, the use of NIRS Neurofeedback was opted for in the search to evaluate the techniques effectiveness in the improvement of ADHD symptoms as well as the patients' cognitive performance. This research is an open label treatment trial with NIRS Neurofeedback training of frontal and pre frontal lobes activation in children school-aged 7 - 12 years old with ADHD. Ten participants will be recruited over 3 months and will be offered 24 NIRS Neurofeedback sessions over 12 weeks, 2 sessions per week. The present study will be carried out as part of the care routine of the Child and Adolescent Psychiatry Services at Hospital de Clínicas de Porto Alegre. Primary outcome will be standard clinical behavioural rating scales. Secondary outcomes will include neuropsychological parameters, neurofunctional parameters using SPECT (Single Photon Emission Computed Tomography), global function, quality of life assessment, side effects and tolerability.

Official Title
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Clinical Trial Using NIRS Neurofeedback on Children With Attention Deficit Hyperactivity Disorder (ADHD)

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Other: NIRS Neurofeedback


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with ADHD clinically. Cognitive dysfunction: ≥11/2; standard deviation above norm in at least two neuropsychological measurements: executive functions (inhibitory control), gratification aversion and time processing Not having used ADHD medication in at least three months with parental consent for not treating ADHD with medication Exclusion Criteria: Existence of another co-morbid mental disorder which is clinically relevant and demands treatment IQ < 80

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NIRS Neurofeedback<br>NIRS Neurofeedback training of frontal and pre frontal lobes activation. The intervention consist of 24 NIRS neurofeedback sessions over 12 weeks, 2 sessions per week. | Other: NIRS Neurofeedback<br>* The sensor will be placed on 4 specific regions defined by the International 10/20 System for Electrode Placement. F7, Fp1, Fp2 and F8. Each region will be initially trained for 4 minutes, with the eyes open, gradually increasing training time throughout the sessions to a maximum of 10 minutes. Training will amount to 24 sessions, occurring 2 times per week over a period of 3 moths. The procedure will be interrupted at any time, should the subject demonstrate the desire to stop.<br>* Other names: Near Infrared Spectroscopy Neurofeedback;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic and severity measure | Swanson, Nolan and Pelham Questionnaire version IV (SNAPIV) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Basic processing | Using Two-choice Reaction Time Task | 3 months | 
| Inhibition control | Using Go/No-Go test | 3 months | 
| Conflict Control | Using Modified Stroop Task | 3 months | 
| Time processing | Using Time Anticipation (400ms e 2000ms) | 3 months | 
| Delay Aversion | Using Choice Delay Task combined with Delay Reaction Time | 3 months | 
| Cerebral blood perfusion | Using SPECT (Single Photon Emission Computed Tomography) toward identifying changes to cerebral blood perfusion in the trained areas (F7, Fp1, Fp2 e F8) and all cortex | 3 months | 
| Psychiatric and social function measure | Children's Global Assessment Scale (CGAS) is an adaptation of the Global Assessment Scale (GAS) for young people aged 4-16 years | 3 months | 
| Treatment response assessment | CGI (Clinical Global Impression) | 3 months | 
| Quality of life | Quality of life evaluation scale (AUQEI) | 3 months | 
| Side Effects | Using SERS (Barkley's Side Effect Rating Scale) | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Near Infrared Spectroscopy, NIRS Neurofeedback, Attention Deficit Hyperactivity Disorder, ADHD