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NIRS Neurofeedback as a Treatment for Attention Deficit Hyperactivity Disorder

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ClinicalTrials.gov Identifier: NCT02333422
Recruitment Status : Unknown
Verified January 2015 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Recruiting
First Posted : January 7, 2015
Last Update Posted : January 7, 2015
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

Study Description
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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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Other: NIRS Neurofeedback Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Trial Using NIRS Neurofeedback on Children With Attention Deficit Hyperactivity Disorder (ADHD)
Study Start Date : July 2014
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Near Infrared Spectroscopy Neurofeedback


Outcome Measures
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Primary Outcome Measures :
  1. Diagnostic and severity measure [ Time Frame: 3 months ]
    Swanson, Nolan and Pelham Questionnaire version IV (SNAPIV)


Secondary Outcome Measures :
  1. Basic processing [ Time Frame: 3 months ]
    Using Two-choice Reaction Time Task

  2. Inhibition control [ Time Frame: 3 months ]
    Using Go/No-Go test

  3. Conflict Control [ Time Frame: 3 months ]
    Using Modified Stroop Task

  4. Time processing [ Time Frame: 3 months ]
    Using Time Anticipation (400ms e 2000ms)

  5. Delay Aversion [ Time Frame: 3 months ]
    Using Choice Delay Task combined with Delay Reaction Time

  6. Cerebral blood perfusion [ Time Frame: 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

  7. Psychiatric and social function measure [ Time Frame: 3 months ]
    Children's Global Assessment Scale (CGAS) is an adaptation of the Global Assessment Scale (GAS) for young people aged 4-16 years

  8. Treatment response assessment [ Time Frame: 3 months ]
    CGI (Clinical Global Impression)

  9. Quality of life [ Time Frame: 3 months ]
    Quality of life evaluation scale (AUQEI)

  10. Side Effects [ Time Frame: 3 months ]
    Using SERS (Barkley's Side Effect Rating Scale)


Eligibility Criteria
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Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02333422


Contacts
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Contact: Clarissa F. Paim 55 51 33598000 ext 8094 cfpaim@hcpa.ufrgs.br
Contact: Igor L Londero 55 51 93340254 igor.londero@terra.com.br

Locations
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Brazil
Hospital de Clínicas de Porto Alegre Recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90035-003
Contact: Igor Londero, Psychologist    55 51 93340254    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         
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
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Principal Investigator: Luis AP Rohde Hospital de Clínicas de Porto Alegre
More Information
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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT02333422    
Other Study ID Numbers: 13-0061
First Posted: January 7, 2015    Key Record Dates
Last Update Posted: January 7, 2015
Last Verified: January 2015
Keywords provided by Hospital de Clinicas de Porto Alegre:
NIRS Neurofeedback
Attention Deficit Hyperactivity Disorder
Near Infrared Spectroscopy
ADHD
Additional relevant MeSH terms:
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Hyperkinesis
Disease
Attention Deficit Disorder with Hyperactivity
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
 Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases