Brain LesionNCT02957695
Neurofeedback in Patients With Frontal Brain Lesions
A study testing Active-Neurofeedback in people with Brain Lesion, run by PD Dr. med. Margret Hund-Georgiadis at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Lesion
- What is being tested?
- Active-Neurofeedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2015to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neurofeedback in Patients With Frontal Brain Lesions: Randomised Controlled Double-blind Trial
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.
Read the 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).
- Conditions
- Brain Lesion
- Being tested
- Placebo-Neurofeedback, Active-Neurofeedback
- Keywords
- frontal brain lesions, neurofeedback, cognitive functions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo-NeurofeedbackDevice
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-NeurofeedbackDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Control Intervention: Placebo-Neurofeedback, 20 sessions Receives: Device: Placebo-Neurofeedback |
| Intervention group | Active comparator | Experimental Intervention: Active-Neurofeedback, 20 sessions Receives: Device: Active-Neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in frontal brain function assessed by FAB (Frontal assessment battery) scale
- Change in the FAB scale (point score) assessed before, after 4 weeks of intervention and after 8 weeks of intervention
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
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.
Measured: 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
Difference in z-scores of quantitative eeg measured before and after 8 weeks of intervention
Measured: Assessment is made before and after 8 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startApr 2015
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Brain LesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- PD Dr. med. Margret Hund-Georgiadis
- Sponsor type
- University, hospital or other
- Collaborators
- Rehab Basel, Swiss Tropical & Public Health Institute
- Responsible party
- Sponsor-investigator, PD Dr. med. Margret Hund-Georgiadis, Rehab Basel
- Investigators
- Margret Hund-Georgiadis, MD, PD, Principal investigator, REHAB Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02957695
- Sponsor's protocol ID
- EKNZ 2015-105
- Status last verified
- Feb 2017
- First submitted
- 13 Mar 2016
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 23649609Gevensleben 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.
PubMed 19207632Levesque 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.
PubMed 16343769May G, Benson R, Balon R, Boutros N. Neurofeedback and traumatic brain injury: a literature review. Ann Clin Psychiatry. 2013 Nov;25(4):289-96.
PubMed 24199220Steiner 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.
PubMed 21561933Wangler 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.
PubMed 20843737Annaheim 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.
PubMed 36188178
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurofeedback in Patients With Frontal Brain Lesions: Randomised Controlled Double-blind Trial
- ClinicalTrials.gov ID
- NCT02957695
- Acronym / sponsor ID
- EKNZ 2015-105
- Conditions
- Brain Lesion
- Keywords
- frontal brain lesions, neurofeedback, cognitive functions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- PD Dr. med. Margret Hund-GeorgiadisUniversity, hospital or other
- Collaborators
- Rehab Basel, Swiss Tropical & Public Health Institute
- Study start
- Apr 2015
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 8 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Device: Placebo-NeurofeedbackControl Intervention: Placebo-Neurofeedback, 20 sessions |
| Intervention group | Active comparator | Device: Active-NeurofeedbackExperimental Intervention: Active-Neurofeedback, 20 sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo-NeurofeedbackThe 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. | Device | Control group |
| Active-NeurofeedbackThe 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. | Device | Intervention group |
Primary outcome
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
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
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
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
2 secondary outcomes
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
Change in quantitative eeg z-scores of coherence and relative power
Time frame: Assessment is made before and after 8 weeks of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
- Background: PubMed 23649609Benke 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.
- Background: PubMed 19207632Gevensleben 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.
- Background: PubMed 16343769Levesque 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.
- Background: PubMed 24199220May G, Benson R, Balon R, Boutros N. Neurofeedback and traumatic brain injury: a literature review. Ann Clin Psychiatry. 2013 Nov;25(4):289-96.
- Background: PubMed 21561933Steiner 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.
- Background: PubMed 20843737Wangler 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.
- Derived from this study: PubMed 36188178Annaheim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margret Hund-Georgiadis, MD, PD principal investigator
REHAB Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active-Neurofeedback in people with Brain Lesion, run by PD Dr. med. Margret Hund-Georgiadis at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02957695, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2017.