Poststroke/CVA ParesisiMoveNCT02325947
Efficacy of Hand Exoskeleton Controlled by BCI in Post Stroke Patients
A study testing hand exoskeleton, brain-computer interface (BCI), in people with Poststroke/CVA Paresis, run by Russian Academy of Medical Sciences at 1 site in Russia.
Trial summary
The purpose of this study is to assess the efficacy of non-invasive BCI-exoskeleton technology based on EEG patterns recognition matching to motor imagery in post-stroke patients with hand paresis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Poststroke/CVA Paresis
- What is being tested?
- hand exoskeleton, brain-computer interface (BCI),
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteRussia
- Study dates
- Jan 2015to Sep 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Medical history of primary acute cerebrovascular event (ischemic or hemorrhagic stroke) at least 4 weeks before screening
- focal stroke located in a hemisphere
- post stroke hand paresis (mild to plegia according to Medical Research Council (MRC) Scale for Muscle Strength)
Who cannot join
- Montreal Cognitive Assessment (MoCA) scale < 22
- Left handedness
- Sensory aphasia
- Severe impairment of vision
- Modified Ashworth Scale (MAS) ≥ 4
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentre Randomized Single Blind Placebo Controlled Study to Assess Efficacy of Hand Exoskeleton Controlled by Motor Imagery Based BCI for Post Stroke Patients Movement Rehabilitation
The purpose of this study is to assess the efficacy of non-invasive BCI-exoskeleton technology based on EEG patterns recognition matching to motor imagery in post-stroke patients with hand paresis.
Read the detailed description
The BCI training is based on EEG activity patterns recording during hand motor imagery. A subject sit comfortably 1m from a computer screen which presents visual instructions during the session. The robotic exoskeleton is fixed to the paretic hand. Subject visually fixate on a circle presented in the center of the screen and receive instructions from three surrounding rhomboidal arrows. Subject is given three commands instructing them to relax or imagine slow hand opening movement with the right or left hand. The "Relax" command means that the subject have to sit still and look at the center of the screen. Commands are presented randomly, each of 10 sec duration.
A visual cue provides the subject with feedback regarding the mental task recognition: the central circle turned green if the classifier recognizes the task in agreement with the given command, or remains white if the signal is not recognized. In addition to visual feedback the subject is provided with kinesthetic feedback: the exoskeleton is opening the hand when the classifier recognizes the imagery of paretic hand movement.
The EEG is registered with 30 electrodes distributed over the head in accordance with the standard international 10-20 system. EEG signals are filtered from 5-30Hz. A Bayesian approach for EEG pattern classifying is used in the system. The activity sources most relevant for BCI functioning will be identified using an independent component analysis (ICA). Classification accuracy will by measured with Cohen's kappa (Kohavi and Provost, 1998). The procedure may consist from up to three sessions, the duration of 1 session is 10 min, there are 5 min time brake between session and total duration of procedure is up to 45 min. The number of procedures - at least 10. The maximal interval between procedures is 3 days.
- Conditions
- Poststroke/CVA Paresis
- Being tested
- hand exoskeleton, brain-computer interface (BCI),, hand exoskeleton, sham BCI
- Keywords
- Post stroke hand paresis brain injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hand exoskeleton, brain-computer interface (BCI),Device
Also called mind-machine interface
Hand exoskeleton, brain-computer interface (BCI) 10 sessions of 45-minutes
hand exoskeleton, sham BCIDevice
Hand exoskeleton, sham BCI 10 sessions of 45-minutes (BCI imitation)
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Hand exoskeleton, brain-computer interface (BCI) 10 sessions of 45-minutes Receives: Device: hand exoskeleton, brain-computer interface (BCI), |
| Placebo group | Sham comparator | Hand exoskeleton, sham BCI 10 sessions of 45-minutes (BCI imitation) Receives: Device: hand exoskeleton, sham BCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in hand paresis level and hand muscle spasticity
ARAT; Fugl-Meyer, Modified Ashworth scale
Measured: Week 2
Secondary outcomes (1)
Long-term changes from Baseline in hand paresis level and hand muscle spasticity
ARAT; Fugl-Meyer, Modified Ashworth scale
Measured: week 4, week 12, week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poststroke/CVA ParesisStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Russian Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Pirogov Russian National Research Medical University
- Responsible party
- Principal investigator, Roman Lyukmanov, Russian Academy of Medical Sciences
- Investigators
- Roman Lyukmanov, MD, Principal investigator, Russian Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02325947
- Sponsor's protocol ID
- iMove
- Acronym
- iMove
- Status last verified
- Sep 2017
- First submitted
- 8 Dec 2014
- Last updated
- 29 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Randomized Single Blind Placebo Controlled Study to Assess Efficacy of Hand Exoskeleton Controlled by Motor Imagery Based BCI for Post Stroke Patients Movement Rehabilitation
- ClinicalTrials.gov ID
- NCT02325947
- Acronym / sponsor ID
- iMove / iMove
- Conditions
- Poststroke/CVA Paresis
- Keywords
- Post stroke hand paresis brain injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Russian Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Pirogov Russian National Research Medical University
- Study start
- Jan 2015
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 25 Dec 2014 (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.
The purpose of this study is to assess the efficacy of non-invasive BCI-exoskeleton technology based on EEG patterns recognition matching to motor imagery in post-stroke patients with hand paresis.
Detailed description
The BCI training is based on EEG activity patterns recording during hand motor imagery. A subject sit comfortably 1m from a computer screen which presents visual instructions during the session. The robotic exoskeleton is fixed to the paretic hand. Subject visually fixate on a circle presented in the center of the screen and receive instructions from three surrounding rhomboidal arrows. Subject is given three commands instructing them to relax or imagine slow hand opening movement with the right or left hand. The "Relax" command means that the subject have to sit still and look at the center of the screen. Commands are presented randomly, each of 10 sec duration.
A visual cue provides the subject with feedback regarding the mental task recognition: the central circle turned green if the classifier recognizes the task in agreement with the given command, or remains white if the signal is not recognized. In addition to visual feedback the subject is provided with kinesthetic feedback: the exoskeleton is opening the hand when the classifier recognizes the imagery of paretic hand movement.
The EEG is registered with 30 electrodes distributed over the head in accordance with the standard international 10-20 system. EEG signals are filtered from 5-30Hz. A Bayesian approach for EEG pattern classifying is used in the system. The activity sources most relevant for BCI functioning will be identified using an independent component analysis (ICA). Classification accuracy will by measured with Cohen's kappa (Kohavi and Provost, 1998). The procedure may consist from up to three sessions, the duration of 1 session is 10 min, there are 5 min time brake between session and total duration of procedure is up to 45 min. The number of procedures - at least 10. The maximal interval between procedures is 3 days.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: hand exoskeleton, brain-computer interface (BCI),Hand exoskeleton, brain-computer interface (BCI) 10 sessions of 45-minutes |
| Placebo group | Sham comparator | Device: hand exoskeleton, sham BCIHand exoskeleton, sham BCI 10 sessions of 45-minutes (BCI imitation) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent
- Medical history of primary acute cerebrovascular event (ischemic or hemorrhagic stroke) at least 4 weeks before screening
- focal stroke located in a hemisphere
- post stroke hand paresis (mild to plegia according to Medical Research Council (MRC) Scale for Muscle Strength)
Key exclusion criteria (5 listed)
- Montreal Cognitive Assessment (MoCA) scale < 22
- Left handedness
- Sensory aphasia
- Severe impairment of vision
- Modified Ashworth Scale (MAS) ≥ 4
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 |
|---|---|---|
| hand exoskeleton, brain-computer interface (BCI),Also: mind-machine interfaceHand exoskeleton, brain-computer interface (BCI) 10 sessions of 45-minutes | Device | Study group |
| hand exoskeleton, sham BCIHand exoskeleton, sham BCI 10 sessions of 45-minutes (BCI imitation) | Device | Placebo group |
Primary outcome
Change from Baseline in hand paresis level and hand muscle spasticity
Time frame: Week 2
ARAT; Fugl-Meyer, Modified Ashworth scale
1 secondary outcome
Long-term changes from Baseline in hand paresis level and hand muscle spasticity
Time frame: week 4, week 12, week 24
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 29 Sep 2017.
- Post-stroke Rehabilitation Training with a Motor-Imagery-Based Brain-Computer Interface (BCI)-Controlled Hand Exoskeleton: A Randomized Controlled Multicenter TrialLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Poststroke/CVA Paresis
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Effects of Atalante Exoskeleton on Gait Recovery in Non- or Poorly Ambulatory Patients With Hemiparesis in the Acute/Subacute Phase (Month 1 to 4)
Stroke, Acute, Stroke, Ischemic
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.
Roman Lyukmanov, MD principal investigator
Russian Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hand exoskeleton, brain-computer interface (BCI), in people with Poststroke/CVA Paresis, run by Russian Academy of Medical Sciences at 1 site in Russia.
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 4 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 29 Sep 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 Russia. 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 from Baseline in hand paresis level and hand muscle spasticity (time frame: Week 2). 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 29 Sep 2017.