Neurofeedback Study ADHD

November 14, 2016 updated by: Winfried Rief, Philipps University Marburg Medical Center
Neurofeedback has proved to be effective in treating Attention deficit hyperactivity disorder (ADHD) in experimental settings. This study investigates whether neurofeedback can be used as a therapeutic intervention in regular outpatient care. The investigators compare high frequent neurofeedback with high frequent self-management therapy and suppose that both result in comparable effects.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
    • Hessen
      • Marburg, Hessen, Germany, 35037
        • Recruiting
        • Philipps-University Marburg, Department of Psychology, Clinical Child and Adolescent Psychology
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hanna Christiansen, PhD

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

7 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • children with ADHD aged 7 to 11
  • full command of the German language.

Exclusion Criteria:

  • IQ below 80

Children with symptoms of:

  • inattention,
  • hyperactivity or

  • impulsivity due to other medical reasons such as:

    • hyperthyreosis,
    • autism,
    • epilepsy,
    • brain disorders and
    • any genetic or medical disorder associated with externalizing behavior that mimics ADHD.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Neurofeedback with Psychoeducation (NF + PE)
Neurofeedback plus Parental Psychoeducation
Behavioral: NF
Behavioral: PE
Active Comparator: Self-Management with Psychoeducation (SM + PE)
Self-management + parental psychoeducation
Behavioral: PE
Behavioral: SM
Active Comparator: NF+PE and additional Social Support (SU)
Neurofeedback + parental psychoeducation enhanced with social support
Behavioral: NF
Behavioral: PE
Behavioral: SU
Active Comparator: SM+PE and additional Social Support (SU)
Self-management + parental psychoeducation enhanced with social support
Behavioral: PE
Behavioral: SM
Behavioral: SU

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Core ADHD symptoms (inattention/hyperactivity/impulsivity) objectively assessed with the computer based Qb-Test (go-no-go-task with infrared camera)
Time Frame: Pre-Post-Change-Design; change for core symptoms from baseline to after 12 weeks, 6 and 12 months

Children perform the Qb-Test:

  • T1 baseline diagnostic before therapy, 1 week
  • T2 post assessment after 36 therapy sessions, expected average of 12 weeks
  • T3 catamnestic measurement 6 months after T2
  • T4 catamnestic measurement 12 months after T2
Pre-Post-Change-Design; change for core symptoms from baseline to after 12 weeks, 6 and 12 months
Conners Psychopathology Scores
Time Frame: Pre-Post-Change-Design; change from baseline to psychopathology scores after 12 weeks, 6 and 12 months

Conners parents & teacher rating scales:

  • T1 baseline diagnostic before therapy, 1 week
  • T2 post assessment after 36 therapy sessions, expected average of 12 weeks
  • T3 catamnestic measurement 6 months after T2
  • T4 catamnestic measurement 12 months after T2
Pre-Post-Change-Design; change from baseline to psychopathology scores after 12 weeks, 6 and 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Social Support
Time Frame: Pre-Post-Change-Design; change from baseline to social support scores after 12 weeks, 6 and 12 months

Children's social support scale:

  • T1 baseline diagnostic before therapy, 1 week
  • T2 post assessment after 36 therapy sessions, expected average of 12 weeks
  • T3 catamnestic measurement 6 months after T2
  • T4 catamnestic measurement 12 months after T2
Pre-Post-Change-Design; change from baseline to social support scores after 12 weeks, 6 and 12 months
Self-Concept
Time Frame: Pre-Post-Change-Design; change from baseline to self-concept scores after 12 weeks, 6 and 12 months

Children's self-concept interview:

  • T1 baseline diagnostic before therapy, 1 week
  • T2 post assessment after 36 therapy sessions, expected average of 12 weeks
  • T3 catamnestic measurement 6 months after T2
  • T4 catamnestic measurement 12 months after T2
Pre-Post-Change-Design; change from baseline to self-concept scores after 12 weeks, 6 and 12 months
Perceived Criticism
Time Frame: Pre-Post-Change-Design; change from baseline to perceived criticism scores after 12 weeks, 6 and 12 months

Assessment of children's perceived criticism:

  • T1 baseline diagnostic before therapy, 1 week
  • T2 post assessment after 36 therapy sessions, expected average of 12 weeks
  • T3 catamnestic measurement 6 months after T2
  • T4 catamnestic measurement 12 months after T2
Pre-Post-Change-Design; change from baseline to perceived criticism scores after 12 weeks, 6 and 12 months
Parental Stress (ESF)
Time Frame: Pre-Post-Change-Design; change from baseline to parental stress scores after 12 weeks, 6 and 12 months

Parent Stress Questionnaire:

  • T1 baseline diagnostic before therapy, 1 week
  • T2 post assessment after 36 therapy sessions, expected average of 12 weeks
  • T3 catamnestic measurement 6 months after T2
  • T4 catamnestic measurement 12 months after T2
Pre-Post-Change-Design; change from baseline to parental stress scores after 12 weeks, 6 and 12 months
Cortisol
Time Frame: Pre-Post-Change-Design; change from baseline to cortisol levels after 12 weeks, 6 and 12 month

Assessed with hair-samples:

  • T1 baseline diagnostic before therapy, 1 week
  • T2 post assessment after 36 therapy sessions, expected average of 12 weeks
  • T3 catamnestic measurement 6 months after T2
  • T4 catamnestic measurement 12 months after T2
Pre-Post-Change-Design; change from baseline to cortisol levels after 12 weeks, 6 and 12 month
Blood/saliva samples for possible genetic correlates of therapy response
Time Frame: End of therapy after 36 sessions
Either saliva sampling or blood samples for genotyping of ADHD candidate genes to establish possible correlates of therapy response
End of therapy after 36 sessions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Philipps University Marburg Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2011

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 28, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 15, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NF-HC

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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