Neurofeedback in Patients With Frontal Brain Lesions

Brain Lesion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02957695
• Other study ID #: EKNZ 2015-105
• Status: Completed
• Phase: N/A
• First received: March 13, 2016
• Last updated: February 8, 2017
• Start date: April 2015
• Est. completion date: February 2017

Study information

• Verified date: February 2017
• Source: Rehab Basel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Lesion

Intervention

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-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.

Locations

Country	Name	City	State
Switzerland	Rehab Basel	Basel

Sponsors (3)

Lead Sponsor	Collaborator
PD Dr. med. Margret Hund-Georgiadis	Rehab Basel, Swiss Tropical & Public Health Institute

Country where clinical trial is conducted

Switzerland, 

References & Publications (6)

Benke T, Karner E, Delazer M. FAB-D: German version of the Frontal Assessment Battery. J Neurol. 2013 Aug;260(8):2066-72. doi: 10.1007/s00415-013-6929-8. — View Citation

Gevensleben H, Holl B, Albrecht B, Vogel C, Schlamp D, Kratz O, Studer P, Rothenberger A, Moll GH, Heinrich H. Is neurofeedback an efficacious treatment for ADHD? A randomised controlled clinical trial. J Child Psychol Psychiatry. 2009 Jul;50(7):780-9. doi: 10.1111/j.1469-7610.2008.02033.x. — View Citation

Lévesque J, Beauregard M, Mensour B. Effect of neurofeedback training on the neural substrates of selective attention in children with attention-deficit/hyperactivity disorder: a functional magnetic resonance imaging study. Neurosci Lett. 2006 Feb 20;394(3):216-21. — View Citation

May G, Benson R, Balon R, Boutros N. Neurofeedback and traumatic brain injury: a literature review. Ann Clin Psychiatry. 2013 Nov;25(4):289-96. Review. — View Citation

Steiner NJ, Sheldrick RC, Gotthelf D, Perrin EC. Computer-based attention training in the schools for children with attention deficit/hyperactivity disorder: a preliminary trial. Clin Pediatr (Phila). 2011 Jul;50(7):615-22. doi: 10.1177/0009922810397887. — View Citation

Wangler S, Gevensleben H, Albrecht B, Studer P, Rothenberger A, Moll GH, Heinrich H. Neurofeedback in children with ADHD: specific event-related potential findings of a randomized controlled trial. Clin Neurophysiol. 2011 May;122(5):942-50. doi: 10.1016/j.clinph.2010.06.036. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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