Clinical trial NCT02333422: NIRS Neurofeedback as a Treatment for Attention Deficit Hyperactivity Disorder
Official title: Clinical Trial Using NIRS Neurofeedback on Children With Attention Deficit Hyperactivity Disorder (ADHD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: NIRS Neurofeedback
Attention Deficit Hyperactivity Disorder
Near Infrared Spectroscopy
ADHD
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2015-01-07
Enrollment: 10
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic and severity measure
timeFrame: 3 months
Secondary outcomes:
measure: Basic processing
timeFrame: 3 months
measure: Inhibition control
timeFrame: 3 months
measure: Conflict Control
timeFrame: 3 months
measure: Time processing
timeFrame: 3 months
measure: Delay Aversion
timeFrame: 3 months
measure: Cerebral blood perfusion
timeFrame: 3 months
measure: Psychiatric and social function measure
timeFrame: 3 months
measure: Treatment response assessment
timeFrame: 3 months
measure: Quality of life
timeFrame: 3 months
measure: Side Effects
timeFrame: 3 months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Luis AP Rohde
role: PRINCIPAL_INVESTIGATOR
References: