ADHDNCT02754336
Working Memory Training and Neurofeedback for Children With ADHD, a Pilot Study
A study testing Cogmed Robomemo, working memory training and Othmer, neurofeedback in people with ADHD, run by Helse Stavanger HF at 1 site in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 7 to 13 years
- Conditions the study is for
- ADHD
- What is being tested?
- Cogmed Robomemo, working memory training and Othmer, neurofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ADHD/ADD
Who cannot join
- Positive effect of metylphenidate
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- ADHD
- Being tested
- Cogmed Robomemo, working memory training, Othmer, neurofeedback
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cogmed Robomemo, working memory trainingBehavioural
Othmer, neurofeedbackBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Cogmed Robomemo, working memory training | Active comparator | Robomemo working memory training, 25 sessions with 8 verbal and non-verbal tasks per session. Receives: Behavioral: Cogmed Robomemo, working memory training |
| Othmer, neurofeedback | Active comparator | Othmer method neurofeedback, 25 sessions a 30 minutes. Receives: Behavioral: Othmer, neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological tests
Subtests from the NEPSY-II test battery
Measured: 3-4 weeks after last training session
Secondary outcomes (2)
Quantum EEG
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"
Measured: 3-4 weeks after last training session
Questionaires
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)
Measured: 3-4 weeks after last training session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startOct 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Harald Beneventi, PhD, Principal investigator, Helse Stavanger HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02754336
- Sponsor's protocol ID
- SUS_ID2012/439
- Status last verified
- Apr 2016
- First submitted
- 22 Nov 2015
- Last updated
- 28 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Working Memory Training and Neurofeedback for Children With ADHD, a Pilot Study
- ClinicalTrials.gov ID
- NCT02754336
- Acronym / sponsor ID
- SUS_ID2012/439
- Conditions
- ADHD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Helse Stavanger HFOther government
- Study start
- Oct 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 28 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cogmed Robomemo, working memory training | Active comparator | Behavioral: Cogmed Robomemo, working memory trainingRobomemo working memory training, 25 sessions with 8 verbal and non-verbal tasks per session. |
| Othmer, neurofeedback | Active comparator | Behavioral: Othmer, neurofeedbackOthmer method neurofeedback, 25 sessions a 30 minutes. |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- ADHD/ADD
Key exclusion criteria (1 listed)
- Positive effect of metylphenidate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cogmed Robomemo, working memory training | Behavioural | Cogmed Robomemo, working memory training |
| Othmer, neurofeedback | Behavioural | Othmer, neurofeedback |
Primary outcome
Neuropsychological tests
Time frame: 3-4 weeks after last training session
Subtests from the NEPSY-II test battery
2 secondary outcomes
Quantum EEG
Time frame: 3-4 weeks after last training session
Questionaires
Time frame: 3-4 weeks after last training session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harald Beneventi, PhD principal investigator
Helse Stavanger HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cogmed Robomemo, working memory training and Othmer, neurofeedback in people with ADHD, run by Helse Stavanger HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychological tests (time frame: 3-4 weeks after last training session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2016.