Neurofeedback in Patients With Frontal Brain Lesions

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Brain Lesion

Intervention / Treatment
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* Device: Placebo-Neurofeedback
* Device: Active-Neurofeedback


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group<br>Control Intervention: Placebo-Neurofeedback, 20 sessions | Device: Placebo-Neurofeedback<br>* 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.<br>|
| Active Comparator: Intervention group<br>Experimental Intervention: Active-Neurofeedback, 20 sessions | Device: Active-Neurofeedback<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in frontal brain function assessed by FAB (Frontal assessment battery) scale | 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 | 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 | 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 | 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) | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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frontal brain lesions, neurofeedback, cognitive functions