NIRS Neurofeedback as a Treatment for Attention Deficit Hyperactivity Disorder

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

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.

Study Overview

• Status: Unknown
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Other: NIRS Neurofeedback

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 Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Clarissa F. Paim; Phone Number: 8094 55 51 33598000; Email: cfpaim@hcpa.ufrgs.br
• Study Contact Backup: Name: Igor L Londero; Phone Number: 55 51 93340254; Email: igor.londero@terra.com.br

Study Locations

• Brazil
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-003
      • Recruiting
      • Hospital de Clinicas de Porto Alegre
      • Contact: Igor Londero, Psychologist; Phone Number: 55 51 93340254; Email: igor.londero@terra.com.br
      • Sub-Investigator: Igor Londero, Psychologist
      • Principal Investigator: Luis AP Rohde, PhD
      • Sub-Investigator: Carine Hunther, Psychologist
      • Sub-Investigator: Guilherme Moritz, Psychologist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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.; Other Names: Near Infrared Spectroscopy Neurofeedback

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Principal Investigator: Luis AP Rohde, Hospital de Clinicas de Porto Alegre

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Anticipated): July 1, 2015
• Study Completion (Anticipated): July 1, 2015

Study Registration Dates

• First Submitted: December 30, 2014
• First Submitted That Met QC Criteria: January 6, 2015
• First Posted (Estimate): January 7, 2015

Study Record Updates

• Last Update Posted (Estimate): January 7, 2015
• Last Update Submitted That Met QC Criteria: January 6, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: ADHD; Attention Deficit Hyperactivity Disorder; Near Infrared Spectroscopy; NIRS Neurofeedback
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Disease; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: 13-0061