Skip to main content
Clinical Trials/NCT02957695
NCT02957695
Completed
Not Applicable

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

PD Dr. med. Margret Hund-Georgiadis1 site in 1 country20 target enrollmentApril 2015
ConditionsBrain Lesion

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Brain Lesion
Sponsor
PD Dr. med. Margret Hund-Georgiadis
Enrollment
20
Locations
1
Primary Endpoint
Change in frontal brain function assessed by the Emotion recognition Test
Status
Completed
Last Updated
9 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
April 2015
End Date
February 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
PD Dr. med. Margret Hund-Georgiadis
Responsible Party
Sponsor Investigator
Principal Investigator

PD Dr. med. Margret Hund-Georgiadis

PD Dr. med.

Rehab Basel

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

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

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

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

Secondary Outcomes

  • Change in quantitative eeg z-scores of coherence and relative power(Assessment is made 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)

Study Sites (1)

Loading locations...

Similar Trials