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Neurofeedback in Patients With Frontal Brain Lesions

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ClinicalTrials.gov Identifier: NCT02957695
Recruitment Status : Completed
First Posted : November 8, 2016
Last Update Posted : February 9, 2017
Sponsor:
Collaborators:
Rehab Basel
Swiss Tropical & Public Health Institute
Information provided by (Responsible Party):
PD Dr. med. Margret Hund-Georgiadis, Rehab Basel

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.

Condition or disease Intervention/treatment Phase
Brain Lesion Device: Placebo-Neurofeedback Device: Active-Neurofeedback Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Neurofeedback in Patients With Frontal Brain Lesions: Randomised Controlled Double-blind Trial
Study Start Date : April 2015
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Arm Intervention/treatment
Placebo Comparator: Control group
Control Intervention: Placebo-Neurofeedback, 20 sessions
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 Comparator: Intervention group
Experimental Intervention: Active-Neurofeedback, 20 sessions
Device: 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.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Secondary Outcome Measures :
  1. Change in behaviour assessed by the Frontal Systems Behavioral Scale (FrSBe) [ Time Frame: Assessments are made before intervention, after 4 weeks of intervention and after 8 weeks of intervention ]
    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.

  2. Change in quantitative eeg z-scores of coherence and relative power [ Time Frame: Assessment is made before and after 8 weeks of intervention ]
    Difference in z-scores of quantitative eeg measured before and after 8 weeks of intervention



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02957695


Locations
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Switzerland
Rehab Basel
Basel, Switzerland, 4012
Sponsors and Collaborators
PD Dr. med. Margret Hund-Georgiadis
Rehab Basel
Swiss Tropical & Public Health Institute
Investigators
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Principal Investigator: Margret Hund-Georgiadis, MD, PD REHAB Basel, Switzerland

Publications:
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Responsible Party: PD Dr. med. Margret Hund-Georgiadis, PD Dr. med., Rehab Basel
ClinicalTrials.gov Identifier: NCT02957695     History of Changes
Other Study ID Numbers: EKNZ 2015-105
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: February 9, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by PD Dr. med. Margret Hund-Georgiadis, Rehab Basel:
frontal brain lesions
neurofeedback
cognitive functions