- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02754336
Working Memory Training and Neurofeedback for Children With ADHD, a Pilot Study
April 25, 2016 updated by: Helse Stavanger HF
This pilot study compares the effect of working memory training and neurofeedback in non-medicated children age 7 to 13 years with ADHD.
Half of the participants will receive working memory training, while the other half will receive neurofeedback.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Stavanger, Norway, 4011
- Stavanger University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 9 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ADHD/ADD
Exclusion Criteria:
- Positive effect of metylphenidate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Cogmed Robomemo, working memory training
Robomemo working memory training, 25 sessions with 8 verbal and non-verbal tasks per session.
|
|
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Active Comparator: Othmer, neurofeedback
Othmer method neurofeedback, 25 sessions a 30 minutes.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neuropsychological tests
Time Frame: 3-4 weeks after last training session
|
Subtests from the NEPSY-II test battery
|
3-4 weeks after last training session
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quantum EEG
Time Frame: 3-4 weeks after last training session
|
Electroencephalography (EEG) is the measurement of electrical patterns at the surface of the scalp which reflect cortical activity, and are commonly referred to as "brainwaves".
Quantitative EEG (qEEG) is the analysis of the digitized EEG, and in lay terms this sometimes is also called "Brain Mapping"
|
3-4 weeks after last training session
|
|
Questionaires
Time Frame: 3-4 weeks after last training session
|
5-15 (FTF) Parent Questionaire For Evaluation of Development and Behavior of 5 to 15-year-old children.
Behavior Rating Inventory of Executive Function (BRIEF)
|
3-4 weeks after last training session
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
November 22, 2015
First Submitted That Met QC Criteria
April 25, 2016
First Posted (Estimate)
April 28, 2016
Study Record Updates
Last Update Posted (Estimate)
April 28, 2016
Last Update Submitted That Met QC Criteria
April 25, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- SUS_ID2012/439
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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