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NIRS Neurofeedback as a Treatment for Attention Deficit Hyperactivity Disorder

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
NIRS Neurofeedback
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring NIRS Neurofeedback, Attention Deficit Hyperactivity Disorder, Near Infrared Spectroscopy, ADHD

Eligibility Criteria

7 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital de Clínicas de Porto AlegreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NIRS Neurofeedback

Arm Description

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.

Outcomes

Primary Outcome Measures

Diagnostic and severity measure
Swanson, Nolan and Pelham Questionnaire version IV (SNAPIV)

Secondary Outcome Measures

Basic processing
Using Two-choice Reaction Time Task
Inhibition control
Using Go/No-Go test
Conflict Control
Using Modified Stroop Task
Time processing
Using Time Anticipation (400ms e 2000ms)
Delay Aversion
Using Choice Delay Task combined with Delay Reaction Time
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
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
Treatment response assessment
CGI (Clinical Global Impression)
Quality of life
Quality of life evaluation scale (AUQEI)
Side Effects
Using SERS (Barkley's Side Effect Rating Scale)

Full Information

First Posted
December 30, 2014
Last Updated
January 6, 2015
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT02333422
Brief Title
NIRS Neurofeedback as a Treatment for Attention Deficit Hyperactivity Disorder
Official Title
Clinical Trial Using NIRS Neurofeedback on Children With Attention Deficit Hyperactivity Disorder (ADHD)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
July 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
NIRS Neurofeedback, Attention Deficit Hyperactivity Disorder, Near Infrared Spectroscopy, ADHD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NIRS Neurofeedback
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
NIRS Neurofeedback
Other Intervention Name(s)
Near Infrared Spectroscopy Neurofeedback
Intervention Description
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.
Primary Outcome Measure Information:
Title
Diagnostic and severity measure
Description
Swanson, Nolan and Pelham Questionnaire version IV (SNAPIV)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Basic processing
Description
Using Two-choice Reaction Time Task
Time Frame
3 months
Title
Inhibition control
Description
Using Go/No-Go test
Time Frame
3 months
Title
Conflict Control
Description
Using Modified Stroop Task
Time Frame
3 months
Title
Time processing
Description
Using Time Anticipation (400ms e 2000ms)
Time Frame
3 months
Title
Delay Aversion
Description
Using Choice Delay Task combined with Delay Reaction Time
Time Frame
3 months
Title
Cerebral blood perfusion
Description
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
Time Frame
3 months
Title
Psychiatric and social function measure
Description
Children's Global Assessment Scale (CGAS) is an adaptation of the Global Assessment Scale (GAS) for young people aged 4-16 years
Time Frame
3 months
Title
Treatment response assessment
Description
CGI (Clinical Global Impression)
Time Frame
3 months
Title
Quality of life
Description
Quality of life evaluation scale (AUQEI)
Time Frame
3 months
Title
Side Effects
Description
Using SERS (Barkley's Side Effect Rating Scale)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clarissa F. Paim
Phone
55 51 33598000
Ext
8094
Email
cfpaim@hcpa.ufrgs.br
First Name & Middle Initial & Last Name or Official Title & Degree
Igor L Londero
Phone
55 51 93340254
Email
igor.londero@terra.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis AP Rohde
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90035-003
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Igor Londero, Psychologist
Phone
55 51 93340254
Email
igor.londero@terra.com.br
First Name & Middle Initial & Last Name & Degree
Igor Londero, Psychologist
First Name & Middle Initial & Last Name & Degree
Luis AP Rohde, PhD
First Name & Middle Initial & Last Name & Degree
Carine Hunther, Psychologist
First Name & Middle Initial & Last Name & Degree
Guilherme Moritz, Psychologist

12. IPD Sharing Statement

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NIRS Neurofeedback as a Treatment for Attention Deficit Hyperactivity Disorder

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