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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	19 February 2015
Main ID:	NCT02333422
Date of registration:	30/12/2014
Prospective Registration:	No
Primary sponsor:	Hospital de Clinicas de Porto Alegre
Public title:	NIRS Neurofeedback as a Treatment for Attention Deficit Hyperactivity Disorder
Scientific title:	Clinical Trial Using NIRS Neurofeedback on Children With Attention Deficit Hyperactivity Disorder (ADHD)
Date of first enrolment:	July 2014
Target sample size:	10
Recruitment status:	Recruiting
URL:	http://clinicaltrials.gov/show/NCT02333422
Study type:	Interventional
Study design:	Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase:	Phase 2

Countries of recruitment
Brazil

Contacts

Name:	Clarissa F. Paim
Address:
Telephone:	55 51 33598000
Email:	cfpaim@hcpa.ufrgs.br
Affiliation:

Name:	Igor Londero, Psychologist
Address:
Telephone:	55 51 93340254
Email:	igor.londero@terra.com.br
Affiliation:

Name:	Luis AP Rohde
Address:
Telephone:
Email:
Affiliation:	Hospital de Clínicas de Porto Alegre

Key inclusion & exclusion 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

Age minimum: 7 Years
Age maximum: 12 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Attention Deficit Hyperactivity Disorder

Intervention(s)

Other: NIRS Neurofeedback

Primary Outcome(s)

Diagnostic and severity measure [Time Frame: 3 months]

Secondary Outcome(s)

Treatment response assessment [Time Frame: 3 months]

Conflict Control [Time Frame: 3 months]

Cerebral blood perfusion [Time Frame: 3 months]

Inhibition control [Time Frame: 3 months]

Quality of life [Time Frame: 3 months]

Time processing [Time Frame: 3 months]

Delay Aversion [Time Frame: 3 months]

Psychiatric and social function measure [Time Frame: 3 months]

Basic processing [Time Frame: 3 months]

Side Effects [Time Frame: 3 months]

Secondary ID(s)

13-0061

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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