NIRS Neurofeedback as a Treatment for Attention Deficit Hyperactivity Disorder
Clinical Trial Using NIRS Neurofeedback on Children With Attention Deficit Hyperactivity Disorder (ADHD)
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jul 2014
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 30, 2014
CompletedFirst Posted
Study publicly available on registry
January 7, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedJanuary 7, 2015
January 1, 2015
1 year
December 30, 2014
January 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diagnostic and severity measure
Swanson, Nolan and Pelham Questionnaire version IV (SNAPIV)
3 months
Secondary Outcomes (10)
Basic processing
3 months
Inhibition control
3 months
Conflict Control
3 months
Time processing
3 months
Delay Aversion
3 months
- +5 more secondary outcomes
Study Arms (1)
NIRS Neurofeedback
EXPERIMENTALNIRS Neurofeedback training of frontal and pre frontal lobes activation. The intervention consist of 24 NIRS neurofeedback sessions over 12 weeks, 2 sessions per week.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Existence of another co-morbid mental disorder which is clinically relevant and demands treatment
- IQ \< 80
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-003, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luis AP Rohde
Hospital de Clínicas de Porto Alegre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 30, 2014
First Posted
January 7, 2015
Study Start
July 1, 2014
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
January 7, 2015
Record last verified: 2015-01