Neurofeedback in Patients With Frontal Brain Lesions

February 8, 2017 updated by: PD Dr. med. Margret Hund-Georgiadis

Neurofeedback in Patients With Frontal Brain Lesions: Randomised Controlled Double-blind Trial

In this randomized double-blind controlled study we would like to test the benefit of neurofeedback for the recovery of patients with frontal brain injury during an early stage of neurorehabilitation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Aim of the study: Patients with a frontal brain lesion often suffer from deficits in brain functions like attention, concentration, planning, impulse control and emotional stability. In this study the investigators would like to test, whether neurofeedback as a non-medication option can help to improve these cognitive functions. Neurofeedback is a method for optimization and stabilization of the brain activity. The brain continuously gets computer-based information about its state. This information is used by the brain for self-regulation. Because neurofeedback is a process based on learning, the positive effects can be integrated into the daily life and seem to persist also after the training stopped. From the literature, several studies have shown promising results of neurofeedback therapy in patients with brain injuries, but no study so far fulfills the scientific criteria which proves a benefit. Methods: The selection of potential study participants is made by the senior or chief physician. Totally, we include 20 patients with a newly acquired frontal brain lesion. 10 patients receive normal neurofeedback training and 10 patients receive a placebo-neurofeedback in a randomized, double blinded manner. In total, 20 neurofeedback sessions are conducted. At the beginning, after 10 sessions and at the end of the intervention time, a neuropsychological assessment is performed to test the main cognitive functions of the frontal brain. Data analysis: The performance in the neuropsychological testing is the primary outcome. We expect that all participants will gain performance during the course of the study due to natural brain recovery, so that we will focus on the difference of the improvements between the two groups (neurofeedback and placebo-group).

Study Type

Interventional

Enrollment (Actual)

20

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

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Middle to severe frontal or frontotemporal brain injury due to accident, bleeding or ischemia, assessed by the Initial Glascow-Coma-Scale from 3 to 12.
  • Time between the injury and inclusion into the study should be 1-6 months
  • The participants must be able to perform simple neuropsychologic tests including sufficient vigilance and motor function for pressing a button.
  • There is no age limitation. The patients who are hospitalized in the REHAB for a initial rehabilitation have a minimum age of 18 years.
  • signed consent form

Exclusion criteria:

  • therapy-resistant symptomatic epilepsy
  • severe cognitive deficits, which do not allow understanding of the required neuropsychological tests, e.g. sensory aphasia.
  • preexisting dementia
  • progressive cerebral diseases e.g. multiple sclerosis, brain tumor
  • schizophrenia

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control group
Control Intervention: Placebo-Neurofeedback, 20 sessions
Device: Placebo-Neurofeedback
The Intervention used for the control-group consists of a sham-neurofeedback, which is based on a previous eeg-recording and doesn't respond to the actual brain activity. The fact, that it is not a real neurofeedback, cannot be recognized by the patient nor the trainer because the eeg recording is not visible and the program reacts to muscle contractions (where feedback reactions would be expected) but not to brain activity.
Active Comparator: Intervention group
Experimental Intervention: Active-Neurofeedback, 20 sessions
Device: Active-Neurofeedback
The neurofeedback-method used in our study is called "infra-low frequency neurofeedback Training", developed by S. and S. Othmer. NeuroAmpII® is the device and Cygnet® the corresponding Software used for this method, both are approved as an active medicinal device (CE-marked) in the European Union and in USA (www.eeginfo.com). The device and the Software are produced by the Company BEE Medic GmbH, Kirchberg, CH.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in frontal brain function assessed by FAB (Frontal assessment battery) scale
Time Frame: Assessments are made before intervention, after 4 weeks of intervention and after 8 weeks of intervention
1. Change in the FAB scale (point score) assessed before, after 4 weeks of intervention and after 8 weeks of intervention
Assessments are made before intervention, after 4 weeks of intervention and after 8 weeks of intervention
Change in frontal brain function assessed by Alertness Test
Time Frame: Assessments are made before intervention, after 4 weeks of intervention and after 8 weeks of intervention
Change in the Alertness Test (T-values) assessed before, after 4 weeks of intervention and after 8 weeks of intervention
Assessments are made before intervention, after 4 weeks of intervention and after 8 weeks of intervention
Change in frontal brain function assessed by the GoNogo-Test
Time Frame: Assessments are made before intervention, after 4 weeks of intervention and after 8 weeks of intervention
Change in the GoNogo-Test (T-values) assessed before, after 4 weeks of intervention and after 8 weeks of intervention
Assessments are made before intervention, after 4 weeks of intervention and after 8 weeks of intervention
Change in frontal brain function assessed by the Emotion recognition Test
Time Frame: Assessments are made before intervention, after 4 weeks of intervention and after 8 weeks of intervention
Change in the Emotion recognition Test (T-values) assessed before, after 4 weeks of intervention and after 8 weeks of intervention
Assessments are made before intervention, after 4 weeks of intervention and after 8 weeks of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in behaviour assessed by the Frontal Systems Behavioral Scale (FrSBe)
Time Frame: Assessments are made before intervention, after 4 weeks of intervention and after 8 weeks of intervention
FrSBe is a questionnaire to assess behaviour as an important frontal brain function. This questionnaire is filled out by the responsible nurse and as a self-rating form by the patient himself. The improvement in behaviour measured by the questionnaire (T-values) assessed before, after 4 weeks and after 8 weeks of Intervention is a secondary outcome.
Assessments are made before intervention, after 4 weeks of intervention and after 8 weeks of intervention
Change in quantitative eeg z-scores of coherence and relative power
Time Frame: Assessment is made before and after 8 weeks of intervention
Difference in z-scores of quantitative eeg measured before and after 8 weeks of intervention
Assessment is made before and after 8 weeks of intervention

Collaborators and Investigators

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

Sponsor

PD Dr. med. Margret Hund-Georgiadis

Collaborators

Swiss Tropical & Public Health Institute
Rehab Basel

Investigators

  • Principal Investigator: Margret Hund-Georgiadis, MD, PD, REHAB Basel, Switzerland

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

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

April 1, 2015

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

March 13, 2016

First Submitted That Met QC Criteria

November 3, 2016

First Posted (Estimate)

November 8, 2016

Study Record Updates

Last Update Posted (Estimate)

February 9, 2017

Last Update Submitted That Met QC Criteria

February 8, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EKNZ 2015-105

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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