StrokeNCT03379532
BCI-controlled NMES in Subacute Stroke
A study testing BCI-NMES in people with Stroke, run by University Hospital, Geneva at 2 sites in 2 countries.
Trial summary
Stroke patients with severe upper limb movement deficits have limited treatment options and often remain severely handicapped at the chronic stage. Recent findings have suggested that poor motor recovery can be due to severe damage of the cortico-spinal tract (CST), the neural fibres connecting the movement regions of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- BCI-NMES
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 26 Jan 2018to 30 Apr 2024
- 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
- Ischemic or hemorrhagic stroke
- Stroke onset ≤ 8 weeks
- Severe, unilateral motor upper extremity hemiparesis (≤15 Fugl-Meyer Score)
- Ability to give informed consent
Who cannot join
- Second stroke during rehabilitation
- Skull breach
- Cardiac pacemaker
- Metallic implants in the brain
- Delirium or disturbed vigilance
- Inability to follow treatments sessions
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- Severe language comprehension deficits
- Severe dystonia or spasticity
- Severe co-morbidity (ex, traumatic, rheumatologic, neurodegenerative diseases)
- Pregnancy
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Switzerland1 site
Division of Neurorehabilitation, University Hospital of Geneva
Geneva, Canton of Geneva, 1211
About this study
Official title: Brain-computer Interface Controlled Neuromuscular Electrical Stimulation in Subacute Stroke
Stroke patients with severe upper limb movement deficits have limited treatment options and often remain severely handicapped at the chronic stage.
Recent findings have suggested that poor motor recovery can be due to severe damage of the cortico-spinal tract (CST), the neural fibres connecting the movement regions of the brain to the spinal cord. Hence, to improve recovery of upper limb movements it will be crucial to re-establish and strengthen CST projections.
Read more
Recent studies provided evidence that closed-loop brain computer interface-driven electrical stimulation of the paretic muscles can induce clinically important and lasting recovery of upper limb function, even in patients with chronic, severe motor affection. In this treatment approach, movement intentions of the patients are detected with electroencephalography and real-time analyses. This triggers an electrical stimulation of affected upper limb muscles.
In this study, the investigators hypothesize that neuromuscular electrical stimulation (NMES) applied contingent to voluntary activation of primary motor cortex, as detected by a brain-computer interface (BCI), can help restore CST projections. This might improve recovery of patients with severe upper limb movement deficits. Treatment will be started within the first 8 weeks after stroke onset.
- Conditions
- Stroke
- Being tested
- BCI-NMES, Sham-NMES
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCI-NMESDevice
From the recorded brain activity (EEG) subject specific patterns will be extracted with machine learning techniques from recordings where the subject executes movements tasks. Whenever a subject-specific pattern can be identified and detected, this is used for triggering neuromuscular electrical stimulation.
Sham-NMESDevice
Neuromuscular electrical stimulation is triggered independently of the patient's movement intentions.
| Study group | Role | What they receive |
|---|---|---|
| BCI-NMES | Active comparator | Electrical stimulation of paretic upper limb is triggered contigent to voluntary motor cortex activation of the patient, as detected by the brain-computer interface. Receives: Device: BCI-NMES |
| Sham-NMES | Sham comparator | Electrical stimulation of paretic upper limb is applied independently of motor cortex activation of the patient by using a prerecorded session of another patient. Receives: Device: Sham-NMES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Upper Limb Fugl-Meyer Score, after treatment
Scale 0-66, higher scores indicate better outcome
Measured: Difference between the week before the intervention and the week after intervention
Secondary outcomes (3)
Change in motor evoked potential amplitude of the paretic arm
Continuous measure, higher amplitude changes indicate better outcome
Measured: Difference between the week before the intervention and the week after intervention
Change in fractional anisotropy (FA) of the cortico-spinal tract as determined from diffusion tensor imaging
FA can have values between 0 and 1, higher values indicate better outcome
Measured: Difference between the week before the intervention and the week after intervention
Change in electroencephalography functional connectivity
Computed from high-density EEG recordings. Continuous measure. Higher values indicate better outcome.
Measured: Difference between the week before the intervention and the week after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start26 Jan 2018
- Primary completion31 Mar 2024
- Study completion30 Apr 2024
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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- Ecole Polytechnique Fédérale de Lausanne, Clinique Romande de Readaptation
- Responsible party
- Principal investigator, Adrian Guggisberg, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03379532
- Sponsor's protocol ID
- CRSII5-170985B
- Status last verified
- May 2024
- First submitted
- 14 Dec 2017
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain-computer Interface Controlled Neuromuscular Electrical Stimulation in Subacute Stroke
- ClinicalTrials.gov ID
- NCT03379532
- Acronym / sponsor ID
- CRSII5-170985B
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- Ecole Polytechnique Fédérale de Lausanne, Clinique Romande de Readaptation
- Study start
- 26 Jan 2018 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 20 Dec 2017 (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.
Stroke patients with severe upper limb movement deficits have limited treatment options and often remain severely handicapped at the chronic stage.
Recent findings have suggested that poor motor recovery can be due to severe damage of the cortico-spinal tract (CST), the neural fibres connecting the movement regions of the brain to the spinal cord. Hence, to improve recovery of upper limb movements it will be crucial to re-establish and strengthen CST projections.
Recent studies provided evidence that closed-loop brain computer interface-driven electrical stimulation of the paretic muscles can induce clinically important and lasting recovery of upper limb function, even in patients with chronic, severe motor affection. In this treatment approach, movement intentions of the patients are detected with electroencephalography and real-time analyses. This triggers an electrical stimulation of affected upper limb muscles.
In this study, the investigators hypothesize that neuromuscular electrical stimulation (NMES) applied contingent to voluntary activation of primary motor cortex, as detected by a brain-computer interface (BCI), can help restore CST projections. This might improve recovery of patients with severe upper limb movement deficits. Treatment will be started within the first 8 weeks after stroke onset.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BCI-NMES | Active comparator | Device: BCI-NMESElectrical stimulation of paretic upper limb is triggered contigent to voluntary motor cortex activation of the patient, as detected by the brain-computer interface. |
| Sham-NMES | Sham comparator | Device: Sham-NMESElectrical stimulation of paretic upper limb is applied independently of motor cortex activation of the patient by using a prerecorded session of another patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ischemic or hemorrhagic stroke
- Stroke onset ≤ 8 weeks
- Severe, unilateral motor upper extremity hemiparesis (≤15 Fugl-Meyer Score)
- Ability to give informed consent
Key exclusion criteria (10 listed)
- Second stroke during rehabilitation
- Skull breach
- Cardiac pacemaker
- Metallic implants in the brain
- Delirium or disturbed vigilance
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-NMESFrom the recorded brain activity (EEG) subject specific patterns will be extracted with machine learning techniques from recordings where the subject executes movements tasks. Whenever a subject-specific pattern can be identified and detected, this is used for triggering neuromuscular electrical stimulation. | Device | BCI-NMES |
| Sham-NMESNeuromuscular electrical stimulation is triggered independently of the patient's movement intentions. | Device | Sham-NMES |
Primary outcome
Change in Upper Limb Fugl-Meyer Score, after treatment
Time frame: Difference between the week before the intervention and the week after intervention
Scale 0-66, higher scores indicate better outcome
3 secondary outcomes
Change in motor evoked potential amplitude of the paretic arm
Time frame: Difference between the week before the intervention and the week after intervention
Change in fractional anisotropy (FA) of the cortico-spinal tract as determined from diffusion tensor imaging
Time frame: Difference between the week before the intervention and the week after intervention
Change in electroencephalography functional connectivity
Time frame: Difference between the week before the intervention and the week after 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 8 May 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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BCI-NMES in people with Stroke, run by University Hospital, Geneva at 2 sites in 2 countries.
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 10 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 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, 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 Upper Limb Fugl-Meyer Score, after treatment (time frame: Difference between the week before the intervention and the week after intervention). 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 8 May 2024.