StrokeMBCI-SRNCT05642299
Multimodal EEG and NIRS-based BCI With Assistive Soft Robotics for Stroke (MBCI-SR)
A study testing MBCI-SR in people with Stroke, run by Tan Tock Seng Hospital at 1 site in Singapore.
Trial summary
One-third of patients who had stroke suffered persistent disabilities, and upper limb (UL) motor impairment is one of the main disabilities. Recent clinical studies had been conducted using non-invasive EEG-based BCI via motor imagery, for post-stroke rehabilitation, yielded motor improvement of 7.2 on the Fugl-Meyer… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- MBCI-SR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Dec 2022to 14 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- first ever stroke prior to clinical trial
- Fugl-Meyer Assessment scale of upper extremity impairment of 11-45 out of a maximum score of 66
- ability to give own consent
- ability to pay attention and maintain supported sitting for 1.5 hours continuously
- able to comprehend and follow commands
- fulfils BCI resting brain states on initial screening
- unilateral upper limb impairment
Who cannot join
- recurrent stroke
- inability to follow command and sit upright for 1.5 hours
- hemi-spatial neglect
- spasticity assessed by Modified Ashworth Scale more than 2/4
- History of Epilepsy
- Fixed contracture / deformity of finger joints
Show all 14Show fewer
- upper limb pain impeding movements with visual analogy scale > 4/10
- Severe aphasia or cognitive impairment despite visual aids
- other conditions ensuing upper limb weakness
- poor skin conditions
- skull defect that might affect EEG or NIRS reading
- allergy to electrodes or adhesive gel
- significant vision and hearing impairment affecting participation
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Tan Tock Seng Hospital Rehabilitation Centre
Singapore, 569766
Chloe Lauha Chung, PhD, 6357 8305, Chloe_lh_chung@ttsh.com.sg
About this study
Official title: Multimodal EEG and NIRS-based BCI With Assistive Soft Robotics for Stroke
One-third of patients who had stroke suffered persistent disabilities, and upper limb (UL) motor impairment is one of the main disabilities. Recent clinical studies had been conducted using non-invasive EEG-based BCI via motor imagery, for post-stroke rehabilitation, yielded motor improvement of 7.2 on the Fugl-Meyer Motor Assessment (FMA-UE)score in chronic stroke patients that is significantly better than standard care. However, all the stroke patients underwent the same "one-size-fits-all" treatment option involving all six different activities of daily living (ADL)-oriented tasks regardless of their impairment or ability.
Investigators hypothesize that precision personalized stroke rehabilitation intervention that is tailored to the patient hold more promise than a "one-size-fits-all" stroke rehabilitation strategy.
Read the detailed description
- To address the "one-size-fits-all" stroke rehabilitation strategy, RRIS will develop an Ability data-driven personalized stroke rehabilitation based on the stroke patient's UL impairment and motor ability, by first matching 6 UL tasks in RRIS Ability Database with the 6 ADL tasks of the BCI-SR Intervention via similarity indices. A personalized subset of ADL tasks treatment options is then generated by a data-driven recommendation based on the patient's ability, movement pattern of the treatment option and the normative data from the RRIS Ability Database. A multi-modal BCI is proposed to perform EEG subject-specific calibration using Near-infrared spectroscopy, NIRS to ensure motor imagery compliance.
- stroke subjects with UL impairments (score 11-45 on the FMA-UE) will be recruited to undergo the UL tasks assessment at RRIS. They will then undergo the personalized stroke rehabilitation using the Multimodal EEG and NIRS-based BCI with Soft Robotic therapy for 1.5 hour over 6 weeks, 3 times a week. The effectiveness of the personalized stroke rehabilitation can then be retrospectively compared to the use of "one-size-fits-all" ADL tasks in the previous clinical trial.
- Conditions
- Stroke
- Being tested
- MBCI-SR
- Keywords
- Brain-Computer Interface; upper limb rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBCI-SRDevice
Participants will be asked to wear and EEG+NIRS cap and a soft robotic glove on their stroke-impaired hand. The participant will be instructed to ask to imagine to picture moving the stroke-imparied hand in the mind. The brain signal (EEG and NIRS data) will be recorded as a reference. When the participant pictures this move again, upon detection of such imagined move by MBCI-SR system, the glove will be activated and assists the participants to perform a specific upper limb task based on individual ability. There are six different activities of daily living (ADL)-oriented tasks enacted through a virtual arm and virtual objects, which formed the visual feedback for the participants. These tasks include scanning goods, moving an object upward to a cabinet, using two hands to move a towel, pouring of water into a cup, eating action and fine motor movement of picking up a small block using two fingers. Training intensity is 1.5 hours for 3 times a week for 6 weeks, a total of 18 sessions.
| Study group | Role | What they receive |
|---|---|---|
| MBCI-SR | Experimental | BCI based robotic rehabilitation works by detecting the motor intent of the user from Electroencephalogram signals to drive rehabilitation assisted by the soft robotics gloves. Receives: Device: MBCI-SR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer score of upper limb
a measure for upper extremity, movement coordination and reflex action.
Measured: Baseline
Fugl-Meyer score of upper limb
a measure for upper extremity, movement coordination and reflex action.
Measured: at week 4 (mid point)
Fugl-Meyer score of upper limb
a measure for upper extremity, movement coordination and reflex action.
Measured: at week 6 (completion of intervention)
Fugl-Meyer score of upper limb
a measure for upper extremity, movement coordination and reflex action.
Measured: at week 12 (at 3 month post intervention)
Fugl-Meyer score of upper limb
a measure for upper extremity, movement coordination and reflex action.
Measured: at week 24 (at 6 month post intervention)
Secondary outcomes (3)
Action Research Arm Test
A measure for upper extremity functioning, such as dexterity and motor coordination, the key components in performing ADLs
Measured: Baseline
Action Research Arm Test
A measure for upper extremity functioning, such as dexterity and motor coordination, the key components in performing ADLs
Measured: at week 12 (at 3 months post intervention)
Action Research Arm Test
A measure for upper extremity functioning, such as dexterity and motor coordination, the key components in performing ADLs
Measured: at week 24 ( at 6 months post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start1 Dec 2022 (estimated)
- Primary completion14 Sep 2023 (estimated)
- Study completion14 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Institute for Infocomm Research, Nanyang Technological University
- Responsible party
- Principal investigator, Chloe Chung Lau Ha, Tan Tock Seng Hospital
- Investigators
- Chloe Lauha Chung, PhD, Principal investigator, Tan Tock Seng HospitalKai Keng Ang, Principal investigator, Institute for Infocomm Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05642299
- Sponsor's protocol ID
- 2021/00715
- Acronym
- MBCI-SR
- Status last verified
- Dec 2022
- First submitted
- 15 Nov 2022
- Last updated
- 8 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Share the study protocol, clinical study report and results
Publications
Daly JJ, Wolpaw JR. Brain-computer interfaces in neurological rehabilitation. Lancet Neurol. 2008 Nov;7(11):1032-43. doi: 10.1016/S1474-4422(08)70223-0. Epub 2008 Oct 2.
PubMed 18835541Ang KK, Chua KS, Phua KS, Wang C, Chin ZY, Kuah CW, Low W, Guan C. A Randomized Controlled Trial of EEG-Based Motor Imagery Brain-Computer Interface Robotic Rehabilitation for Stroke. Clin EEG Neurosci. 2015 Oct;46(4):310-20. doi: 10.1177/1550059414522229. Epub 2014 Apr 21.
PubMed 24756025Ang KK, Guan C, Phua KS, Wang C, Zhou L, Tang KY, Ephraim Joseph GJ, Kuah CW, Chua KS. Brain-computer interface-based robotic end effector system for wrist and hand rehabilitation: results of a three-armed randomized controlled trial for chronic stroke. Front Neuroeng. 2014 Jul 29;7:30. doi: 10.3389/fneng.2014.00030. eCollection 2014.
PubMed 25120465Cheng N, Phua KS, Lai HS, Tam PK, Tang KY, Cheng KK, Yeow RC, Ang KK, Guan C, Lim JH. Brain-Computer Interface-Based Soft Robotic Glove Rehabilitation for Stroke. IEEE Trans Biomed Eng. 2020 Dec;67(12):3339-3351. doi: 10.1109/TBME.2020.2984003. Epub 2020 Nov 19.
PubMed 32248089Ang KK, Guan C, Chua KS, Ang BT, Kuah CW, Wang C, Phua KS, Chin ZY, Zhang H. A large clinical study on the ability of stroke patients to use an EEG-based motor imagery brain-computer interface. Clin EEG Neurosci. 2011 Oct;42(4):253-8. doi: 10.1177/155005941104200411.
PubMed 22208123
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal EEG and NIRS-based BCI With Assistive Soft Robotics for Stroke
- ClinicalTrials.gov ID
- NCT05642299
- Acronym / sponsor ID
- MBCI-SR / 2021/00715
- Conditions
- Stroke
- Keywords
- Brain-Computer Interface; upper limb rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Collaborators
- Institute for Infocomm Research, Nanyang Technological University
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 14 Sep 2023 (estimated)
- Study completion
- 14 Dec 2023 (estimated)
- First posted
- 8 Dec 2022 (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.
One-third of patients who had stroke suffered persistent disabilities, and upper limb (UL) motor impairment is one of the main disabilities. Recent clinical studies had been conducted using non-invasive EEG-based BCI via motor imagery, for post-stroke rehabilitation, yielded motor improvement of 7.2 on the Fugl-Meyer Motor Assessment (FMA-UE)score in chronic stroke patients that is significantly better than standard care. However, all the stroke patients underwent the same "one-size-fits-all" treatment option involving all six different activities of daily living (ADL)-oriented tasks regardless of their impairment or ability.
Investigators hypothesize that precision personalized stroke rehabilitation intervention that is tailored to the patient hold more promise than a "one-size-fits-all" stroke rehabilitation strategy.
Detailed description
- To address the "one-size-fits-all" stroke rehabilitation strategy, RRIS will develop an Ability data-driven personalized stroke rehabilitation based on the stroke patient's UL impairment and motor ability, by first matching 6 UL tasks in RRIS Ability Database with the 6 ADL tasks of the BCI-SR Intervention via similarity indices. A personalized subset of ADL tasks treatment options is then generated by a data-driven recommendation based on the patient's ability, movement pattern of the treatment option and the normative data from the RRIS Ability Database. A multi-modal BCI is proposed to perform EEG subject-specific calibration using Near-infrared spectroscopy, NIRS to ensure motor imagery compliance.
- stroke subjects with UL impairments (score 11-45 on the FMA-UE) will be recruited to undergo the UL tasks assessment at RRIS. They will then undergo the personalized stroke rehabilitation using the Multimodal EEG and NIRS-based BCI with Soft Robotic therapy for 1.5 hour over 6 weeks, 3 times a week. The effectiveness of the personalized stroke rehabilitation can then be retrospectively compared to the use of "one-size-fits-all" ADL tasks in the previous clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MBCI-SR | Experimental | Device: MBCI-SRBCI based robotic rehabilitation works by detecting the motor intent of the user from Electroencephalogram signals to drive rehabilitation assisted by the soft robotics gloves. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- first ever stroke prior to clinical trial
- Fugl-Meyer Assessment scale of upper extremity impairment of 11-45 out of a maximum score of 66
- ability to give own consent
- ability to pay attention and maintain supported sitting for 1.5 hours continuously
- able to comprehend and follow commands
Key exclusion criteria (14 listed)
- recurrent stroke
- inability to follow command and sit upright for 1.5 hours
- hemi-spatial neglect
- spasticity assessed by Modified Ashworth Scale more than 2/4
- History of 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 |
|---|---|---|
| MBCI-SRParticipants will be asked to wear and EEG+NIRS cap and a soft robotic glove on their stroke-impaired hand. The participant will be instructed to ask to imagine to picture moving the stroke-imparied hand in the mind. The brain signal (EEG and NIRS data) will be recorded as a reference. When the participant pictures this move again, upon detection of such imagined move by MBCI-SR system, the glove will be activated and assists the participants to perform a specific upper limb task based on individual ability. There are six different activities of daily living (ADL)-oriented tasks enacted through a virtual arm and virtual objects, which formed the visual feedback for the participants. These tasks include scanning goods, moving an object upward to a cabinet, using two hands to move a towel, pouring of water into a cup, eating action and fine motor movement of picking up a small block using two fingers. Training intensity is 1.5 hours for 3 times a week for 6 weeks, a total of 18 sessions. | Device | MBCI-SR |
Primary outcome
Fugl-Meyer score of upper limb
Time frame: Baseline
a measure for upper extremity, movement coordination and reflex action.
Fugl-Meyer score of upper limb
Time frame: at week 4 (mid point)
a measure for upper extremity, movement coordination and reflex action.
Fugl-Meyer score of upper limb
Time frame: at week 6 (completion of intervention)
a measure for upper extremity, movement coordination and reflex action.
Fugl-Meyer score of upper limb
Time frame: at week 12 (at 3 month post intervention)
a measure for upper extremity, movement coordination and reflex action.
Fugl-Meyer score of upper limb
Time frame: at week 24 (at 6 month post intervention)
a measure for upper extremity, movement coordination and reflex action.
3 secondary outcomes
Action Research Arm Test
Time frame: Baseline
Action Research Arm Test
Time frame: at week 12 (at 3 months post intervention)
Action Research Arm Test
Time frame: at week 24 ( at 6 months post intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
- Background: PubMed 18835541Daly JJ, Wolpaw JR. Brain-computer interfaces in neurological rehabilitation. Lancet Neurol. 2008 Nov;7(11):1032-43. doi: 10.1016/S1474-4422(08)70223-0. Epub 2008 Oct 2.
- Results publication: PubMed 24756025Ang KK, Chua KS, Phua KS, Wang C, Chin ZY, Kuah CW, Low W, Guan C. A Randomized Controlled Trial of EEG-Based Motor Imagery Brain-Computer Interface Robotic Rehabilitation for Stroke. Clin EEG Neurosci. 2015 Oct;46(4):310-20. doi: 10.1177/1550059414522229. Epub 2014 Apr 21.
- Results publication: PubMed 25120465Ang KK, Guan C, Phua KS, Wang C, Zhou L, Tang KY, Ephraim Joseph GJ, Kuah CW, Chua KS. Brain-computer interface-based robotic end effector system for wrist and hand rehabilitation: results of a three-armed randomized controlled trial for chronic stroke. Front Neuroeng. 2014 Jul 29;7:30. doi: 10.3389/fneng.2014.00030. eCollection 2014.
- Results publication: PubMed 32248089Cheng N, Phua KS, Lai HS, Tam PK, Tang KY, Cheng KK, Yeow RC, Ang KK, Guan C, Lim JH. Brain-Computer Interface-Based Soft Robotic Glove Rehabilitation for Stroke. IEEE Trans Biomed Eng. 2020 Dec;67(12):3339-3351. doi: 10.1109/TBME.2020.2984003. Epub 2020 Nov 19.
- Results publication: PubMed 22208123Ang KK, Guan C, Chua KS, Ang BT, Kuah CW, Wang C, Phua KS, Chin ZY, Zhang H. A large clinical study on the ability of stroke patients to use an EEG-based motor imagery brain-computer interface. Clin EEG Neurosci. 2011 Oct;42(4):253-8. doi: 10.1177/155005941104200411.
- Individual participant dataSharing planned: No. Share the study protocol, clinical study report and results
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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.
Chloe Lauha Chung, PhD principal investigator
Tan Tock Seng Hospital
Kai Keng Ang principal investigator
Institute for Infocomm Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MBCI-SR in people with Stroke, run by Tan Tock Seng Hospital at 1 site in Singapore.
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 7 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 8 Dec 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 Singapore. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chloe Lauha Chung, PhD (+65 6357 8305, chloe_lh_chung@ttsh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer score of upper limb (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05642299, which also lists 5 linked publications.
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 Dec 2022.