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StrokeNCT04847089

Motor Imagery BCI Rehabilitation After Stroke

A study testing Motor imagery BCI training in people with Stroke and Hemiparesis, run by Mälardalen University at 3 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This research project will investigate motor imagery training in stroke rehabilitation during which patients receive feedback in real time from their brain activity measured with ElectroEncephaloGraphy (EEG). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Hemiparesis
What is being tested?
Motor imagery BCI training
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
3 sitesSweden
Study dates
14 Apr 2022to 1 Jul 2025
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

  • > 6 months since first time stroke onset and with remaining hemiparesis in upper extremity; able to participate fully in the intervention, able to perform Functional Magnetic Resonance Imaging (fMRI); able to passively extend the wrist 15 degrees and extend fingers fully with a neutral position of the wrist.
  • In addition, participants need to be able to voluntarily control the power of their grip when requested according to the Visuomotor force tracking method and/or according to the clinical assessment of a therapist (while holding the patient´s hand). According to the Fugl- Meyer Upper Extremity (UE) scale participants should accomplish <14 points on the hand subscale and <2 points in finger flexion and extension (C) in addition to < 47 points on the total motor score (equivalent to moderate disability in the upper extremity.

Who cannot join

  • other neurological or musculoskeletal disease/injury, or contagious disease.
  • If the research person is regularly treated with botulinum toxin in the upper extremity, 3 weeks should have passed before the first baseline assessment.
  • current or history of epilepsy,
  • severe hearing or visual impairments,
  • metal implants in the brain/skull cochlear implants,
  • any implanted neurostimulator, cardiac pacemaker or cardiac implants of metal, infusion device,
Show all 9Show fewer
  • any other neurological disorder,
  • pregnancy,
  • current or history of severe psychiatric disorder with need for pharmacological treatment

Trial locations and contacts

3 sites in 1 country.

Sweden3 sites
  • Stockholn University Brain Imaging Centre

    Stockholm, 11418

  • Department of rehabilitation medicine at Danderyd University

    Stockholm, 18288

  • Sweden Mälardalen University

    Västerås, 72123

Other trials in Sweden

About this study

Official title: Motor Imagery and Real-time Feedback in Stroke Rehabilitation

This research project will investigate motor imagery training in stroke rehabilitation during which patients receive feedback in real time from their brain activity measured with ElectroEncephaloGraphy (EEG). The investigators hypothesize that the feedback training allows to internally stimulate brain motor networks in order to promote functional recovery of the hand.

Read the detailed description

This study will be carried out as an explorative study in order to investigate the benefits of mental imagery training of hand movements guided through Brain-Computer Interface (BCI) feedback after stroke. Stroke patients will be trained to mentally imagine the opening and closing of the hand (hereafter named MI, Motor Imagery). During the training, the patients will receive visual feedback in real time that reflects the neural activity related to motor processes. The NeuroFeedback (NF) will be projected with minimal time delay to maximize the neural learning. This type of brain training with feedback is thought to have significant importance to stimulate the ability of the brain to reorganize and compensate for a damaged region.

Each participant will go through the following data collection procedure (total of 33 measurement sessions per RP):

Week 1-3:

Clinical baseline evaluations, 1 time/week MRI measurements, 1 time/week during 2 weeks. Baseline EEG recordings, 1 time/week Week 4-7 MI-neurofeedback training 3 times/week Clinical intervention evaluation, 1 time/week Week 8-10 Same as week 1-3

Magnetic Resonance Imaging (MRI) measurements. The MRI exam will be carried out on a Siemens MAGNETOM Prisma 3T scanner (head-coil with 20 channels) at baseline and at final assessment session at Stockholm University Brain Imaging Centre. The MRI protocol comprises i) anatomical whole brain spin-echo T1 and T2 weighted sequences for description of lesion size and location ii) acquisition of T2*-weighted gradient echo EPI-BOLD images of the whole brain for assessment of resting state functional connectivity of sensorimotor networks (resting-state functional MRI (fMRI)), and iii) the same sequence as the previous with rest interleaved by a motor imagery paradigm further described below.

Motor Imagery (MI) paradigm. The paradigm consists of instructing RP, by the use of a mirrored computer screen, to either i) rest his/her mind with eyes closed, ii) mentally imagine a hand movement (MI), or ii) execute a hand movement. The hand movements that are instructed are either to close the hand or to open the hand and extend the fingers. RP will perform several repetitions of each hand movement (MI and execution) in order to collect a statistical basis.

Baseline EEG recording. During the baseline EEG recordings, RP will be seated in front a computer screen and perform the MI paradigm (described above). During these session, EEG, EOG, EMG, and accelerometer-data will be collected and are further described below.

ElectroEncephaloGram (EEG), ElectroOculoGram (EOG), ElectroMyoGram (EMG) and accelerometer equipment. The EEG equipment consists of a 64-electrode scalp EEG acquisition system (Brain Products ActiCHamp). The 64 electrodes (active Ag/AgCl) will be distributed according to the extended 10-20 reference placement system. In addition to the EEG recording, 3 electrodes (passive Ag/AgCl, Brain Products) will be placed on each side of both eyes and on the earlob to measure eye-movements during the experiment (EOG). EMG electrodes (passive Ag/AgCl, Brain Products) will be placed over four muscles controlling the wrist and fingers according to a standardized protocol. Two accelerometer-sensors (Brain Products) will be placed on the hand and the index finger in order to record movement-related activity.

EEG, EOG, EMG and accelerometer data analysis. The recorded data will be further analyzed offline in order to evaluate the characteristic features in the data that best describe MI of hand movements. This will be performed in Matlab and Labview combining custom-made scripts with already developed toolboxes (such as EEGLab, Chronux). Features to be evaluated will include the evoked activity, the time-frequency spectra, phase, correlation coefficients, coherency among other. When the feature that best describes MI has been identified different classifier and pattern recognition methods will be evaluated in extracting the information. Intelligent algorithms, Support Vector Machine (SVM), regularized linear regression, naïve Bayes classifiers among others will be evaluated and compared. These are commonly used methods in the field of neurotechnology and a prior comparison-study using neural data from invasive recordings shows the importance of choosing a well-adapted classifier for extracting information.

MI-NeuroFeedback Training (NFT). EEG, EOG, EMG and accelerometer-data will be collected as described in the section "EEG, EMG and accelerometer equipment". RP will perform the MI paradigm without the execution of hand movements. Real-time feedback from recorded EEG-activity will be provided to RP during MI. The feedback consists of a virtual hand on a computer screen whose movements reflect the brain activity of RP related to MI. The recorded data will be further analyzed offline with the analytic tools that are described in previous section.

Conditions
Stroke, Hemiparesis
Being tested
Motor imagery BCI training
Medical subject headings
Stroke, Paresis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Motor imagery BCI trainingDevice

    Motor Imagery (MI)-BCI training, 2-3 hours, 3 times/week for 4 weeks.

Study groups in NCT04847089
Study groupRoleWhat they receive
Motor Imagery BCI trainingExperimentalComplete intervention with motor imagery BCI training. Patients recruited by physiotherapists who underwent baseline evaluations with clinical tests, fMRI and EEG measurements. Patients will after intervention perform clinical tests, fMRI, and EEG measurements to evaluate outcomes of intervention.
Receives: Device: Motor imagery BCI training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of Fugl-Meyer Upper Extremity scale score (0-66 points)

    Arm and hand function

    Measured: Up to 10 weeks

  2. Change of EEG alpha and beta activity

    Brain motor network activity reflected in BCI feedback

    Measured: Up to 10 weeks

  3. Change of fMRI BOLD activity

    Brain motor network activity

    Measured: Up to 10 weeks

Secondary outcomes (5)
  1. Change of monofilament test score

    Two point discrimination and monofilament test for sensory function

    Measured: Up to 10 weeks

  2. Change of box and block test score (0-150)

    Gross manual dexterity

    Measured: Up to 10 weeks

  3. Change of JAMAR® digital Hand Dynamometer scores (0-90)

    Grip strength

    Measured: Up to 10 weeks

  4. Change of visuomotor force-tracking task scores

    Quantification of timing and precision aspects of force grip modulation

    Measured: Up to 10 weeks

  5. Change of stroke Impact Scale 16 scores (15-80 points)

    Activity limitations related to physical function

    Measured: Up to 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2021
  2. Study start14 Apr 2022
  3. Primary completion1 Jul 2025
  4. Study completion1 Jul 2025

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04847089
Sponsor's protocol ID
2021-01075
Status last verified
Dec 2025
First submitted
14 Apr 2021
Last updated
22 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Motor imagery BCI training in people with Stroke and Hemiparesis, run by Mälardalen University at 3 sites in Sweden.

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 2 inclusion and 9 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 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Sweden. 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 of Fugl-Meyer Upper Extremity scale score (0-66 points) (time frame: Up to 10 weeks). The study lists 3 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 22 Dec 2025.

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