NIRS Neurofeedback as a Treatment for Attention Deficit Hyperactivity Disorder

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02333422
• Other study ID #: 13-0061
• Status: Recruiting
• Phase: Phase 2
• First received: December 30, 2014
• Last updated: January 6, 2015
• Start date: July 2014
• Est. completion date: July 2015

Study information

• Verified date: January 2015
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Clarissa F. Paim
• Phone: 55 51 33598000
• Email: cfpaim[@]hcpa.ufrgs.br
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 12 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Other:
• NIRS Neurofeedback
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.

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic and severity measure	Swanson, Nolan and Pelham Questionnaire version IV (SNAPIV)	3 months	No
Secondary	Basic processing	Using Two-choice Reaction Time Task	3 months	No
Secondary	Inhibition control	Using Go/No-Go test	3 months	No
Secondary	Conflict Control	Using Modified Stroop Task	3 months	No
Secondary	Time processing	Using Time Anticipation (400ms e 2000ms)	3 months	No
Secondary	Delay Aversion	Using Choice Delay Task combined with Delay Reaction Time	3 months	No
Secondary	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	No
Secondary	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	No
Secondary	Treatment response assessment	CGI (Clinical Global Impression)	3 months	No
Secondary	Quality of life	Quality of life evaluation scale (AUQEI)	3 months	No
Secondary	Side Effects	Using SERS (Barkley's Side Effect Rating Scale)	3 months	No