NCT02754336

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

April 28, 2016

Completed
Last Updated

April 28, 2016

Status Verified

April 1, 2016

Enrollment Period

8 months

First QC Date

November 22, 2015

Last Update Submit

April 25, 2016

Conditions

ADHD

Outcome Measures

Primary Outcomes (1)

  • Neuropsychological tests

    Subtests from the NEPSY-II test battery

    3-4 weeks after last training session

Secondary Outcomes (2)

  • Quantum EEG

    3-4 weeks after last training session

  • Questionaires

    3-4 weeks after last training session

Study Arms (2)

Cogmed Robomemo, working memory training

ACTIVE COMPARATOR

Robomemo working memory training, 25 sessions with 8 verbal and non-verbal tasks per session.

Behavioral: Cogmed Robomemo, working memory training

Othmer, neurofeedback

ACTIVE COMPARATOR

Othmer method neurofeedback, 25 sessions a 30 minutes.

Behavioral: Othmer, neurofeedback

Interventions

Cogmed Robomemo, working memory trainingBEHAVIORAL
Cogmed Robomemo, working memory training
Othmer, neurofeedbackBEHAVIORAL
Othmer, neurofeedback

Eligibility Criteria

Age7 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ADHD/ADD

You may not qualify if:

  • Positive effect of metylphenidate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stavanger University Hospital

Stavanger, 4011, Norway

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Biofeedback, PsychologyMind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Study Officials

  • Harald Beneventi, PhD

    Helse Stavanger HF

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2015

First Posted

April 28, 2016

Study Start

October 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

April 28, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)