Neurofeedback and Working Memory Training for Children and Adolescents With ADHD

NCT ID: NCT01841151

Last Updated: 2025-08-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2020-10-31

Brief Summary

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The purpose of this study is to investigate if neurofeedback and working memory training improves core symptoms of ADHD in children and adolescents.

Detailed Description

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This study investigates two types of Neurofeedback (NF), one well-established and well-researched protocol called Slow Cortical Potential NF (SCP), and a newer and less researched, yet popular among private clinicians, the so-called live z-score training (LZT). These methods are compared to working memory training (WMT) and a passive control condition, treatment-as-usual only (TAU). The active conditions (SCP/LZT/WMT) are delivered high frequent, with 5 sessions/week, for a total of 25 sessions.

Outcomes measures are taken at Preintervention and Postintervention, as well as at a 6-month follow-up assessment.

Conditions

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Attention Deficit Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SCP training

Neurofeedback 1 (NF1) Slow Cortical Potential (SCP) training

Group Type ACTIVE_COMPARATOR

SCP training

Intervention Type BEHAVIORAL

Live Z-score training

Neurofeedback 2 (NF2) Live Z-score training

Group Type ACTIVE_COMPARATOR

Live Z-score training

Intervention Type BEHAVIORAL

WM training

Working Memory training (WMt)

Group Type ACTIVE_COMPARATOR

WM training

Intervention Type BEHAVIORAL

Waiting-list

Treatment as usual only

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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SCP training

Intervention Type BEHAVIORAL

Live Z-score training

Intervention Type BEHAVIORAL

WM training

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Clinical AD/HD diagnose according to DSM-IV-TR and K-SADS interview, 9-17 years old, unmedicated or under stable medication with stimulants or corresponding since at least one month.

Exclusion Criteria

* IQ \<70 (WISC-IV or WAIS-IV), clinically instable psychiatric state e.g. severe depression, OCD, self-injurious behaviour, bipolar disorder, severe somatic (neurologic) disease, very limited knowledge in the Swedish language.
Minimum Eligible Age

9 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Stockholm

OTHER_GOV

Sponsor Role collaborator

Child and Adolescent Psychiatry, Stockholm

INDUSTRY

Sponsor Role collaborator

Stiftelsen Sunnerdahls Handikappfond

OTHER

Sponsor Role collaborator

Swedish Foundation for Strategic Research

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Sven Bölte

Professor, PhD, head of pediatric neuropsychiatry unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sven Bölte, Professor

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institute, Competence Center of Neurodevelopmental Disorders (KIND)

Locations

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Cap Bup-Kind

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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Hasslinger, J., Sirviö, S., Berggren, S., Myers, L., Flygare, O., Tammimies, K., & Bölte, S. (2016). A comparative randomized controlled pragmatic trial of neurofeedback and working memory training for children with attention-deficit/hyperactivity disorder: protocol. Translational Developmental Psychiatry, 4(1). https://doi.org/10.3402/tdp.v4.30556

Reference Type BACKGROUND

Hasslinger J, D'Agostini Souto M, Folkesson Hellstadius L, Bolte S. Neurofeedback in ADHD: A qualitative study of strategy use in slow cortical potential training. PLoS One. 2020 Jun 4;15(6):e0233343. doi: 10.1371/journal.pone.0233343. eCollection 2020.

Reference Type RESULT
PMID: 32497051 (View on PubMed)

Hasslinger J, Bolte S, Jonsson U. Slow Cortical Potential Versus Live Z-score Neurofeedback in Children and Adolescents with ADHD: A Multi-arm Pragmatic Randomized Controlled Trial with Active and Passive Comparators. Res Child Adolesc Psychopathol. 2022 Apr;50(4):447-462. doi: 10.1007/s10802-021-00858-1. Epub 2021 Sep 3.

Reference Type RESULT
PMID: 34478006 (View on PubMed)

Hasslinger J, Jonsson U, Bolte S. Immediate and Sustained Effects of Neurofeedback and Working Memory Training on Cognitive Functions in Children and Adolescents with ADHD: A Multi-Arm Pragmatic Randomized Controlled Trial. J Atten Disord. 2022 Sep;26(11):1492-1506. doi: 10.1177/10870547211063645. Epub 2022 Jan 16.

Reference Type RESULT
PMID: 35034510 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

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Related Links

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Other Identifiers

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KITE

Identifier Type: -

Identifier Source: org_study_id

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