Neurofeedback in Patients With Frontal Brain Lesions

Not Applicable

Completed

• Conditions: Brain Lesion
• Interventions: Device: Active-Neurofeedback; Device: Placebo-Neurofeedback

• Registration Number: NCT02957695
• Lead Sponsor: PD Dr. med. Margret Hund-Georgiadis

Brief Summary

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

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 Timeline

• Study Start: 2015-04
• Study First Submitted: 2016-03-13
• Study First Submitted QC: 2016-11-03
• Study First Posted: 2016-11-08
• Status Verified: 2017-02
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Last Update Submitted: 2017-02-08
• Last Update Posted: 2017-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Active-Neurofeedback	Experimental Intervention: Active-Neurofeedback, 20 sessions
Control group	Placebo-Neurofeedback	Control Intervention: Placebo-Neurofeedback, 20 sessions

Primary Outcome Measures

Name	Time	Method
Change in frontal brain function assessed by the Emotion recognition Test	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
Change in frontal brain function assessed by the GoNogo-Test	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
Change in frontal brain function assessed by Alertness Test	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
Change in frontal brain function assessed by FAB (Frontal assessment battery) scale	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

Secondary Outcome Measures

Name	Time	Method
Change in quantitative eeg z-scores of coherence and relative power	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
Change in behaviour assessed by the Frontal Systems Behavioral Scale (FrSBe)	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.

Trial Locations

Locations (1)

Rehab Basel; 🇨🇭 Basel, Switzerland