StrokeNCT04071587
Brain Computer Interface Training After Stroke
A study testing Brain Computer Interface training in people with Stroke, run by University of Aarhus at 1 site in Denmark.
Trial summary
In this study, we want to examine the effect of a new treatment approach for patients with severe upper limb paresis in the subacute phase after stroke. Brain Computer Interface (BCI) driven functional electrical stimulation will be compared to conventional training. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Stroke
- What is being tested?
- Brain Computer Interface training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 26 Aug 2019to 31 Mar 2022
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First ever or former stroke without UL motor residuals as confirmed by CT and / or MRI
- 15 days to 60 days (+/- 3) after stroke onset
- Severe paresis or paralysis defined as < 13 on Action Research arm Test (ARAT)
- Able to give informed consent
- Able to comply with treatment protocol.
Who cannot join
- Other conditions limiting functional use of the affected UL,
- Psychiatric / behavioral conditions that interfere with compliance to the protocol, epilepsy
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Hammel Neurorehabilitation Centre and University Research Clinic
Hammel, Aarhus, 8450
About this study
Official title: Brain Computer Interface Training for Patients With Severe Upper Limb Paresis in the Subacute Phase After Stroke
In this study, we want to examine the effect of a new treatment approach for patients with severe upper limb paresis in the subacute phase after stroke. Brain Computer Interface (BCI) driven functional electrical stimulation will be compared to conventional training.
Read the detailed description
A randomized controlled pilot study will be conducted. Forty patients with severe UL paresis will be included. Patients with severe hemiparesis after stroke will be allocated to one of two treatment groups by a computerized randomization program. Patients in the intervention group will receive training with a BCI system paired with functional electrical stimulation and visual feedback (RecoveriX, gtec, Austria) as part of their rehabilitation. The targeted number of training sessions in the intervention group is 12. Patients in the control group will receive conventional upper limb training. All patients will receive other rehabilitation according to their needs.
Patients will be assessed by blinded raters before and after the intervention and 3 months post stroke. Main endpoint will be UL motor function assessed by Action Research Arm Test (ARAT) at 3 months post stroke. Other outcome measures comprise Fugl Meyer Motor Assessment and Functional Independence Measure. The patients and therapists' experience with this type of training will be evaluated with questionnaires and interviews.
- Conditions
- Stroke
- Being tested
- Brain Computer Interface training, Control
- Keywords
- BCI, upper limb, severe paresis, subacute stroke, rehabilitation
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Computer Interface trainingDevice
Training with RecoveriX system.
ControlBehavioural
Standard physiotherapy and occupational therapy according to clinical routines.
| Study group | Role | What they receive |
|---|---|---|
| BCI training | Experimental | Patients randomized to this group will receive up to12 (minimum 8) sessions of BCI training with the RecoveriX system (gtec, Austria). The system combines EEG driven functional electrical stimulation with visual feedback. BCI training is provided as a part of standard training of the impaired upper limb. Receives: Device: Brain Computer Interface training |
| Control | Active comparator | Patients randomized to this control group will receive standard physiotherapy and occupational therapy for their impaired upper limb. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Action Research Arm Test (ARAT)
Upper limb function on a scale of 0 - 57 (best)
Measured: Upper limb function 90 days after stroke
Secondary outcomes (2)
Fugl-Meyer Assessment (UL)
Upper limb impairment on a scale from 0-66 (best)
Measured: Upper limb impairment 90 days after stroke
Functional Independence Measure
Independence in activities og daily living, 18-126 (best)
Measured: Functional independence 90 days after stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start26 Aug 2019
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
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.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Model description
- Patients are randomized to one of two treatment options, intervention or standard rehabilitation
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Hammel Neurorehabilitation Centre and University Research Clinic, Sygekassernes Helsefond
- Responsible party
- Sponsor
- Investigators
- Iris Brunner, PhD, Principal investigator, Aarhus University, Hammel Neurocenter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04071587
- Sponsor's protocol ID
- 649780
- Status last verified
- Jan 2022
- First submitted
- 21 Aug 2019
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Computer Interface Training for Patients With Severe Upper Limb Paresis in the Subacute Phase After Stroke
- ClinicalTrials.gov ID
- NCT04071587
- Acronym / sponsor ID
- 649780
- Conditions
- Stroke
- Keywords
- BCI, upper limb, severe paresis, subacute stroke, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Hammel Neurorehabilitation Centre and University Research Clinic, Sygekassernes Helsefond
- Study start
- 26 Aug 2019 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 28 Aug 2019 (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.
In this study, we want to examine the effect of a new treatment approach for patients with severe upper limb paresis in the subacute phase after stroke. Brain Computer Interface (BCI) driven functional electrical stimulation will be compared to conventional training.
Detailed description
A randomized controlled pilot study will be conducted. Forty patients with severe UL paresis will be included. Patients with severe hemiparesis after stroke will be allocated to one of two treatment groups by a computerized randomization program. Patients in the intervention group will receive training with a BCI system paired with functional electrical stimulation and visual feedback (RecoveriX, gtec, Austria) as part of their rehabilitation. The targeted number of training sessions in the intervention group is 12. Patients in the control group will receive conventional upper limb training. All patients will receive other rehabilitation according to their needs.
Patients will be assessed by blinded raters before and after the intervention and 3 months post stroke. Main endpoint will be UL motor function assessed by Action Research Arm Test (ARAT) at 3 months post stroke. Other outcome measures comprise Fugl Meyer Motor Assessment and Functional Independence Measure. The patients and therapists' experience with this type of training will be evaluated with questionnaires and interviews.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients are randomized to one of two treatment options, intervention or standard rehabilitation
| Arm | Type | Receives |
|---|---|---|
| BCI training | Experimental | Device: Brain Computer Interface trainingPatients randomized to this group will receive up to12 (minimum 8) sessions of BCI training with the RecoveriX system (gtec, Austria). The system combines EEG driven functional electrical stimulation with visual feedback. BCI training is provided as a part of standard training of the impaired upper limb. |
| Control | Active comparator | Behavioral: ControlPatients randomized to this control group will receive standard physiotherapy and occupational therapy for their impaired upper limb. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- First ever or former stroke without UL motor residuals as confirmed by CT and / or MRI
- 15 days to 60 days (+/- 3) after stroke onset
- Severe paresis or paralysis defined as < 13 on Action Research arm Test (ARAT)
- Able to give informed consent
- Able to comply with treatment protocol.
Key exclusion criteria (2 listed)
- Other conditions limiting functional use of the affected UL,
- Psychiatric / behavioral conditions that interfere with compliance to the protocol, epilepsy
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 |
|---|---|---|
| Brain Computer Interface trainingTraining with RecoveriX system. | Device | BCI training |
| ControlStandard physiotherapy and occupational therapy according to clinical routines. | Behavioural | Control |
Primary outcome
Action Research Arm Test (ARAT)
Time frame: Upper limb function 90 days after stroke
Upper limb function on a scale of 0 - 57 (best)
2 secondary outcomes
Fugl-Meyer Assessment (UL)
Time frame: Upper limb impairment 90 days after stroke
Functional Independence Measure
Time frame: Functional independence 90 days after stroke
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 14 Nov 2022.
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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.
Iris Brunner, PhD principal investigator
Aarhus University, Hammel Neurocenter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain Computer Interface training in people with Stroke, run by University of Aarhus at 1 site in Denmark.
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 2 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 14 Nov 2022. 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 Denmark. 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?
Action Research Arm Test (ARAT) (time frame: Upper limb function 90 days after stroke). 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 14 Nov 2022; AzTrials last refreshed its copy on 4 Nov 2026.