Neurofeedback in Patients With Frontal Brain Lesions

PD Dr. med. Margret Hund-Georgiadis

Status

Completed

Conditions

Brain Lesion

Treatments

Device: Placebo-Neurofeedback

Device: Active-Neurofeedback

Study type

Interventional

Funder types

Other

Identifiers

NCT02957695

EKNZ 2015-105

Details and patient eligibility

About

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.

Full 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).

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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