StrokeNCT04376138
Longitudinal Validation of Neurofeedback in Stroke Motor Rehabilitation Through Brain Imaging
A study testing BCI intervention and Conventional Therapy in people with Stroke, run by Universidade da Madeira at 1 site in Portugal.
Trial summary
With the main goal of generalising findings into Virtual Reality-Neurofeedback-Motor imagery (VR-NF-MI) system, this project aims to develop a new motor rehabilitation tool, for the upper limb, allied to the use of rising of information and communication technologies (ICT). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- BCI intervention and Conventional Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 sitePortugal
- Study dates
- 17 Aug 2019to 31 Dec 2023
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First stroke episode
- More than six months after stroke
- Stroke hemiplegia/hemiparesis, (Fugl Meyer below or equal to 47)
- Capacity to understand and complete simple tasks
- Know how to read and write
- Motivation to participate
Who cannot join
- Hemi spatial neglect
- Depressive symptoms, moderate to severe
- Presence of other neurological or orthopaedic problems
- Severe eyesight problems
- Claustrophobia
- Presence of ferromagnetic materials
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Serviço de Saúde da Região Autónoma da Madeira
Funchal, Madeira, 9004-514
About this study
With the main goal of generalising findings into Virtual Reality-Neurofeedback-Motor imagery (VR-NF-MI) system, this project aims to develop a new motor rehabilitation tool, for the upper limb, allied to the use of rising of information and communication technologies (ICT). By identifying correlations on the neural activity, during motor imagery and through brain imaging (fMRI), with distinct training protocols and feedback, these protocols are developed to create user-specific models that later can be used in NF-MI rehabilitation sessions.
Read the detailed description
Every year millions of people worldwide suffer from stroke, being one of the leading causes of death and longterm disability. This leads to cognitive and motor impairments, resulting in loss of independence in their daily life together with an additional psychological impact in mood disorders and depression. Evolving to a chronic condition, stroke requires continuous rehabilitation and therapy. Personalised Virtual-Reality (VR) approaches have been shown to accelerate the recovery process compared to non-Information and communication technologies (ICT) based interventions. However, most of these novel VR approaches are suitable only for a reduced subset of patients, generally those with better recovery prognostics and better motor control. Thus, the idea of training the central nervous system was established, through EEG-based neurofeedback (NF) and motor-imagery (MI). Although the benefits of MI-NF have been illustrated in a plethora of studies, the reduced ability for stroke patients to use NF does not allow an accurate control, reducing the capabilities of MI-NF systems. The aim of this project is to develop a novel and more inclusive rehabilitation system with the use of novel ICT technologies, in order to overcome current limitations. This will be achieved by identifying the neural correlates of motor action during motor imagery through brain imaging (fMRI), and differences in brain activation with different training feedback protocols for formulating user-specific models that will be used later in NF-MI rehabilitation sessions. This will facilitate the use of neural interfaces to train the central nervous system; specifically, the investigators will develop a personalized EEG-based immersive NF through VR for MI training. The ultimate goal is to generalize the findings into a VR-NF-MI training paradigm for both admitted and ambulatory patients as well as continued domestic care.
- Conditions
- Stroke
- Being tested
- BCI intervention, Conventional Therapy
- Keywords
- Brain Computer Interface, Virtual Reality, Stroke rehabilitation, Electroencephalography, Motor Imagery
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCI interventionOther
Also called Brain Computer Interaction (BCI) and neurofeedback for stroke rehabilitation
30 minutes intervention that occurs 3 times per week, with a goal of 12 sessions total.
Conventional TherapyOther
Also called Traditional motor rehabilitation for the upper limb
30 minutes intervention that occurs 3 times per week, with a goal of 12 sessions total.
| Study group | Role | What they receive |
|---|---|---|
| Motor Imagery | Experimental | A Brain-Computer Interaction (BCI) based intervention while receiving conventional therapy. Use of motor imagery training, allied with brain-computer interaction, as a solution to promote motor and cognitive gains in stroke survivors. Receives: Other: BCI intervention |
| Conventional Therapy | Active comparator | Extra Occupational Therapy sessions while receiving conventional therapy. Use of conventional therapy techniques and tools for motor rehabilitation, following the original therapeutic intervention plan of the participants. Receives: Other: Conventional Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from the baseline in the functional magnetic resonance imaging (fMRI)
Analyze cortical activation, during motor imagery exercises, and cortical structure.
Measured: Baseline, Final (4 weeks) and 1 month follow up
Change from the baseline in the Fugl Meyer Motor Assessment
Evaluates the motor function of the affected upper limb. This section has a maximum score of 66 and changes to a higher score means an evolution on motor recovery.
Measured: Baseline, Final (4 weeks) and 1 month follow up
Secondary outcomes (5)
Change from the baseline in the electroencephalography (EEG) data
Analyze brain activity during motor imagery training to identify the best EEG features that better correlate with the brain activity in motor areas of each participant using Common Spatial Pattern filters. Examine different modulation rhythms focusing on Alpha and Beta rhythms, during Motor imagery for each BCI session, aiming to find changes in brain activity, in motor and cognitive areas that are related to motor imagery. Some feature candidates are, Power, Connectivity and Event-Related Synchronization/Desynchronization (ERS/ERD) maps.
Measured: In all 12 sessions for 4 weeks
Change from the baseline in the Kinesthetic and Visual Imagery Questionnaire (KVIQ)
Assess the motor imagery capacity of the stroke participants. The maximum score is 100 and a high score reflects a greater ability to visualize and feel imaginary movements.
Measured: Baseline, Final (4 weeks) and 1 month follow up
Change from the baseline in the Montreal Cognitive Assessment (MoCA)
The screening test used to assess different cognitive domains. The test has a total of 30 points; the higher the score the lesser the probability of cognitive impairment.
Measured: Baseline, Final (4 weeks) and 1 month follow up
Change from the baseline in the Modified Ashworth Scale (MAS)
Assess muscle tone during movement, in the elbow joint. The score is valued from 0 to 4 (0, 1, 1+, 2, 3 and 4), a higher score is related to higher spasticity and muscle tone.
Measured: Baseline, Final (4 weeks) and 1 month follow up
Change from the baseline in the Geriatric Depression Scale (GDS)
Self-report assessment to measure depression symptoms in the elderly. It has a maximum score of 30 points where a score superior to 21 is indicative of the presence of severe depression. From 11 to 20 points is indicative of mild depression and a score equal or inferior to 10, to the absence of depression.
Measured: Baseline, Final (4 weeks) and 1 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start17 Aug 2019
- Primary completion30 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade da Madeira
- Sponsor type
- University, hospital or other
- Collaborators
- Serviço de Saúde da Região Autónoma da Madeira (SESARAM), E.P.E.
- Responsible party
- Principal investigator, Sergi Bermúdez i Badia, Universidade da Madeira
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04376138
- Sponsor's protocol ID
- 031485
- Status last verified
- Dec 2024
- First submitted
- 16 Apr 2020
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Validation of Neurofeedback in Stroke Motor Rehabilitation Through Brain Imaging
- ClinicalTrials.gov ID
- NCT04376138
- Acronym / sponsor ID
- 031485
- Conditions
- Stroke
- Keywords
- Brain Computer Interface, Virtual Reality, Stroke rehabilitation, Electroencephalography, Motor Imagery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Universidade da MadeiraUniversity, hospital or other
- Collaborators
- Serviço de Saúde da Região Autónoma da Madeira (SESARAM), E.P.E.
- Study start
- 17 Aug 2019 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 6 May 2020 (actual)
- 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.
With the main goal of generalising findings into Virtual Reality-Neurofeedback-Motor imagery (VR-NF-MI) system, this project aims to develop a new motor rehabilitation tool, for the upper limb, allied to the use of rising of information and communication technologies (ICT). By identifying correlations on the neural activity, during motor imagery and through brain imaging (fMRI), with distinct training protocols and feedback, these protocols are developed to create user-specific models that later can be used in NF-MI rehabilitation sessions.
Detailed description
Every year millions of people worldwide suffer from stroke, being one of the leading causes of death and longterm disability. This leads to cognitive and motor impairments, resulting in loss of independence in their daily life together with an additional psychological impact in mood disorders and depression. Evolving to a chronic condition, stroke requires continuous rehabilitation and therapy. Personalised Virtual-Reality (VR) approaches have been shown to accelerate the recovery process compared to non-Information and communication technologies (ICT) based interventions. However, most of these novel VR approaches are suitable only for a reduced subset of patients, generally those with better recovery prognostics and better motor control. Thus, the idea of training the central nervous system was established, through EEG-based neurofeedback (NF) and motor-imagery (MI). Although the benefits of MI-NF have been illustrated in a plethora of studies, the reduced ability for stroke patients to use NF does not allow an accurate control, reducing the capabilities of MI-NF systems. The aim of this project is to develop a novel and more inclusive rehabilitation system with the use of novel ICT technologies, in order to overcome current limitations. This will be achieved by identifying the neural correlates of motor action during motor imagery through brain imaging (fMRI), and differences in brain activation with different training feedback protocols for formulating user-specific models that will be used later in NF-MI rehabilitation sessions. This will facilitate the use of neural interfaces to train the central nervous system; specifically, the investigators will develop a personalized EEG-based immersive NF through VR for MI training. The ultimate goal is to generalize the findings into a VR-NF-MI training paradigm for both admitted and ambulatory patients as well as continued domestic care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motor Imagery | Experimental | Other: BCI interventionA Brain-Computer Interaction (BCI) based intervention while receiving conventional therapy. Use of motor imagery training, allied with brain-computer interaction, as a solution to promote motor and cognitive gains in stroke survivors. |
| Conventional Therapy | Active comparator | Other: Conventional TherapyExtra Occupational Therapy sessions while receiving conventional therapy. Use of conventional therapy techniques and tools for motor rehabilitation, following the original therapeutic intervention plan of the participants. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- First stroke episode
- More than six months after stroke
- Stroke hemiplegia/hemiparesis, (Fugl Meyer below or equal to 47)
- Capacity to understand and complete simple tasks
- Know how to read and write
Key exclusion criteria (6 listed)
- Hemi spatial neglect
- Depressive symptoms, moderate to severe
- Presence of other neurological or orthopaedic problems
- Severe eyesight problems
- Claustrophobia
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 |
|---|---|---|
| BCI interventionAlso: Brain Computer Interaction (BCI) and neurofeedback for stroke rehabilitation30 minutes intervention that occurs 3 times per week, with a goal of 12 sessions total. | Other | Motor Imagery |
| Conventional TherapyAlso: Traditional motor rehabilitation for the upper limb30 minutes intervention that occurs 3 times per week, with a goal of 12 sessions total. | Other | Conventional Therapy |
Primary outcome
Change from the baseline in the functional magnetic resonance imaging (fMRI)
Time frame: Baseline, Final (4 weeks) and 1 month follow up
Analyze cortical activation, during motor imagery exercises, and cortical structure.
Change from the baseline in the Fugl Meyer Motor Assessment
Time frame: Baseline, Final (4 weeks) and 1 month follow up
Evaluates the motor function of the affected upper limb. This section has a maximum score of 66 and changes to a higher score means an evolution on motor recovery.
5 secondary outcomes
Change from the baseline in the electroencephalography (EEG) data
Time frame: In all 12 sessions for 4 weeks
Change from the baseline in the Kinesthetic and Visual Imagery Questionnaire (KVIQ)
Time frame: Baseline, Final (4 weeks) and 1 month follow up
Change from the baseline in the Montreal Cognitive Assessment (MoCA)
Time frame: Baseline, Final (4 weeks) and 1 month follow up
Change from the baseline in the Modified Ashworth Scale (MAS)
Time frame: Baseline, Final (4 weeks) and 1 month follow up
Change from the baseline in the Geriatric Depression Scale (GDS)
Time frame: Baseline, Final (4 weeks) and 1 month follow up
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 13 Dec 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BCI intervention and Conventional Therapy in people with Stroke, run by Universidade da Madeira at 1 site in Portugal.
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 6 inclusion and 6 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 13 Dec 2024. 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 Portugal. 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. 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 from the baseline in the functional magnetic resonance imaging (fMRI) (time frame: Baseline, Final (4 weeks) and 1 month follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Dec 2024.