NIRS Neurofeedback as a Treatment for Attention Deficit Hyperactivity Disorder

Phase 2

• Conditions: Attention Deficit Hyperactivity Disorder
• Interventions: Other: NIRS Neurofeedback

• Registration Number: NCT02333422
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-12-30
• Status Verified: 2015-01
• Study First Submitted QC: 2015-01-06
• Last Update Submitted: 2015-01-06
• Study First Posted: 2015-01-07
• Last Update Posted: 2015-01-07
• Primary Completion: 2015-07
• Study Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NIRS Neurofeedback	NIRS Neurofeedback	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.

Primary Outcome Measures

Name	Time	Method
Diagnostic and severity measure	3 months	Swanson, Nolan and Pelham Questionnaire version IV (SNAPIV)

Secondary Outcome Measures

Name	Time	Method
Inhibition control	3 months	Using Go/No-Go test
Conflict Control	3 months	Using Modified Stroop Task
Time processing	3 months	Using Time Anticipation (400ms e 2000ms)
Delay Aversion	3 months	Using Choice Delay Task combined with Delay Reaction Time
Basic processing	3 months	Using Two-choice Reaction Time Task
Psychiatric and social function measure	3 months	Children's Global Assessment Scale (CGAS) is an adaptation of the Global Assessment Scale (GAS) for young people aged 4-16 years
Treatment response assessment	3 months	CGI (Clinical Global Impression)
Quality of life	3 months	Quality of life evaluation scale (AUQEI)
Side Effects	3 months	Using SERS (Barkley's Side Effect Rating Scale)
Cerebral blood perfusion	3 months	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

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil