Clinical trial NCT02957695: Neurofeedback in Patients With Frontal Brain Lesions
Official title: Neurofeedback in Patients With Frontal Brain Lesions: Randomised Controlled Double-blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Lesion
Keywords: frontal brain lesions
neurofeedback
cognitive functions
Lead sponsor: Rehab Basel
Sponsor class: OTHER
Collaborators: name: Rehab Basel
name: Swiss Tropical & Public Health Institute
First posted: 2016-11-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in frontal brain function assessed by FAB (Frontal assessment battery) scale
timeFrame: Assessments are made before intervention, after 4 weeks of intervention and after 8 weeks of intervention
measure: Change in frontal brain function assessed by Alertness Test
timeFrame: Assessments are made before intervention, after 4 weeks of intervention and after 8 weeks of intervention
measure: Change in frontal brain function assessed by the GoNogo-Test
timeFrame: Assessments are made before intervention, after 4 weeks of intervention and after 8 weeks of intervention
measure: Change in frontal brain function assessed by the Emotion recognition Test
timeFrame: Assessments are made before intervention, after 4 weeks of intervention and after 8 weeks of intervention
Secondary outcomes:
measure: Change in behaviour assessed by the Frontal Systems Behavioral Scale (FrSBe)
timeFrame: Assessments are made before intervention, after 4 weeks of intervention and after 8 weeks of intervention
measure: Change in quantitative eeg z-scores of coherence and relative power
timeFrame: Assessment is made before and after 8 weeks of intervention
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Rehab Basel
Study officials:
affiliation: REHAB Basel, Switzerland
name: Margret Hund-Georgiadis, MD, PD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. Epub 2013 May 7.
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. Epub 2009 Jan 12.
citation: Levesque 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. doi: 10.1016/j.neulet.2005.10.100. Epub 2005 Dec 15.
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.
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. Epub 2011 May 10.
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. Epub 2010 Sep 16.
citation: Annaheim C, Hug K, Stumm C, Messerli M, Simon Y, Hund-Georgiadis M. Neurofeedback in patients with frontal brain lesions: A randomized, controlled double-blind trial. Front Hum Neurosci. 2022 Sep 15;16:979723. doi: 10.3389/fnhum.2022.979723. eCollection 2022.