Neurofeedback in Patients With Frontal Brain Lesions

NCT02957695 | Completed

• 1 other identifier: EKNZ 2015-105
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Lesion

Keywords

frontal brain lesions; neurofeedback; cognitive functions

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (2)

• 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

• Change in quantitative eeg z-scores of coherence and relative power

  Assessment is made before and after 8 weeks of intervention

Study Arms (2)

Control group

PLACEBO COMPARATOR

Control Intervention: Placebo-Neurofeedback, 20 sessions

Device: Placebo-Neurofeedback

Intervention group

ACTIVE COMPARATOR

Experimental Intervention: Active-Neurofeedback, 20 sessions

Device: Active-Neurofeedback

Interventions

Placebo-Neurofeedback DEVICE

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.

Control group

Active-Neurofeedback DEVICE

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PD Dr. med. Margret Hund-Georgiadis: lead
• Rehab Basel: collaborator
• Swiss Tropical & Public Health Institute: collaborator

Study Sites (1)

Rehab Basel

Basel, 4012, Switzerland

Location

Related Publications (7)

• 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.

  PMID: 23649609 BACKGROUND

• 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.

  PMID: 19207632 BACKGROUND

• 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.

  PMID: 16343769 BACKGROUND

• 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.

  PMID: 24199220 BACKGROUND

• 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.

  PMID: 21561933 BACKGROUND

• 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.

  PMID: 20843737 BACKGROUND

• 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.

  PMID: 36188178 DERIVED

Study Officials

• Margret Hund-Georgiadis, MD, PD

  REHAB Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PD Dr. med.

Study Record Dates

• First Submitted: March 13, 2016
• First Posted: November 8, 2016
• Study Start: April 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: February 9, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)