NIRS Neurofeedback as a Treatment for Attention Deficit Hyperactivity Disorder

NCT ID: NCT02333422

Last Updated: 2015-01-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-07-31

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.

Conditions

Attention Deficit Hyperactivity Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

NIRS Neurofeedback

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Near Infrared Spectroscopy Neurofeedback

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luis AP Rohde

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clínicas de Porto Alegre

Locations

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Clarissa F. Paim

Role: CONTACT

cfpaim@hcpa.ufrgs.br

55 51 33598000 ext. 8094

Igor L Londero

Role: CONTACT

igor.londero@terra.com.br

55 51 93340254

Facility Contacts

Igor Londero, Psychologist

Role: primary

igor.londero@terra.com.br

55 51 93340254

Other Identifiers

13-0061

Identifier Type: -

Identifier Source: org_study_id