StrokenBETTERNCT02765334
A Study of Neurostyle Brain Exercise Therapy Towards Enhanced Recovery (nBETTER) for Stroke
A study testing nBETTER in people with Stroke, run by Tan Tock Seng Hospital at 1 site in Singapore.
Trial summary
A feasibility trial of Neurostyle Brain Exercise Therapy Towards Enhanced Recovery (nBETTER) system for Brain Computer Interface (BCI) neurofeedback for rehabilitation of the subacute and chronic hemiplegic upper limb aimed at improving upper limb recovery for subacute to chronic stroke patients. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- nBETTER
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteSingapore
- Study dates
- 28 Dec 2015to 16 Aug 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 21-80 years with first-ever clinical stroke diagnosed on CT or MRI brain imaging.
- Stroke duration of 3-24 months.
- Stroke type: ischemic or haemorrhagic
- Fugl-Meyer motor score of the upper limb range from 10-50
- Ability to pay attention and maintain supported sitting for 1.5 hours continuously
- Able to give own consent and understand simple instructions
- Fulfils BCI resting brain states on initial screening.
Who cannot join
- Recurrent clinical stroke
- Functional status: severe aphasia or inattention, unstable medical conditions which may affect participation (e.g. unresolved sepsis, postural hypotension, end stage renal failure) or anticipated life expectancy of <1 year due to malignancy or neurodegenerative disorder)
- Hemispatial neglect (visual or sensory) or severe visual impairment despite visual aids
- History of epilepsy, severe depression or active psychiatric disorder
- Skull defect or previous cranial surgery as this would affect physical fit of EEG cap interface
- Local arm factors: severe spasticity Modified Ashworth scale >2 in any region, visual analogue scale (VAS score) >4/10, fixed joint contractures or joint replacements, patients with poor skin conditions which would contraindicate repetitive arm training.
- TMS contraindications: females with reproductive potential not on reliable contraception; pregnancy; cardiac pacemakers; orthodontics (braces); metal implants.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Feasibility Clinical Trial of Neurostyle Brain Exercise Therapy Towards Enhanced Recovery (nBETTER) for postStroke Arm Paresis
A feasibility trial of Neurostyle Brain Exercise Therapy Towards Enhanced Recovery (nBETTER) system for Brain Computer Interface (BCI) neurofeedback for rehabilitation of the subacute and chronic hemiplegic upper limb aimed at improving upper limb recovery for subacute to chronic stroke patients.
Read the detailed description
Stroke remains the 4th cause of death in Singapore and despite advances in neuro-medical care and rehabilitation, 40-50% of stroke survivors are left with permanent neuro-disability and a reduced quality of life. The previous 2 decades has seen exponential leaps in the development of rehabilitation technologies which enhance neuroplasticity and rehabilitation outcome. One of these potentially useful technologies is nBETTER System, was developed by Institute for Infocomm Research, Agency for Science, Technology and Research (A*STAR). nBETTER is a portable, internet-connected device that detects the imagination of movement of stroke-affected limb using a Electroencephalography (EEG)-based Brain-Computer Interface (BCI) thus delivering visually engaging feedback for directed neurofeedback aimed at improving upper limb recovery for subacute to chronic stroke patients. The pilot study aims to recruit 13 patients using a multi centre trial design to investigate nBETTER system feasibility and safety for rehabilitation of subacute to chronic stroke patients with upper limb motor impairment and to determine clinical efficacy, safety and feasibility of such a system when it is delivered with standard occupational therapy.
The investigators primary hypothesis is that nBETTER is a feasible and safe prototype in stroke survivors (> 3 months) with moderate to severe arm impairment (FMMA 10-50). The primary outcome is a gain of 15% in Fugl-Meyer motor scores at 6 weeks after 18 sessions (total of 27 hours) of supervised training by occupational therapists and bioengineers.
- Conditions
- Stroke
- Being tested
- nBETTER
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nBETTERDevice
60 minutes of nBETTER training followed by 30 minutes of conventional therapy occupational therapy. Total of 18 sessions over 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| nBETTER and Conventional Therapy | Experimental | Intervention: nBetter therapy Receives: Device: nBETTER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Upper extremity Fugl-Meyer motor score post training
As above
Measured: Baseline and week 6
Secondary outcomes (5)
Change in Transcranial Magnetic Stimulation Assessment (TMS)
As above
Measured: Baseline and week 6
Change in Grip Strength
Grip Strength measures hand force in kgf
Measured: Baseline and week 6
Change in Frenchay Arm Test of Function (FAT)
Frenchay Arm Test of Function (FAT) measures 5 tasks:
- Stabilize ruler and draw line
- Grasp and lift cylinder without dropping
- Pick up half glass and drink
- Replace sprung clothes peg
- Comb hair from top down (sides and back of head)
Measured: Baseline and week 6
Change in Modified Ashworth Scale score (MAS)
Modified Ashworth Scale score (MAS) measure spasticity of wrist and hand finger flexors on a scale from 0 to 4
Measured: Baseline and week 6
Change in Visual Analogue Scale (VAS)
Visual Analogue Scale (VAS) measures pain on a scale from 0 to 10
Measured: Baseline and week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study start28 Dec 2015
- Primary completion16 Aug 2017
- Study completion16 Aug 2017
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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility of nBETTER training (60 minutes) with conventional arm therapy (30minutes) for chronic stroke.
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Institute for Infocomm Research, National University Hospital, Singapore
- Responsible party
- Sponsor
- Investigators
- Karen S Chua, MBBS, FRCP, Principal investigator, Tan Tock Seng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02765334
- Sponsor's protocol ID
- 2014/01164
- Other IDs
- 2014
- Acronym
- nBETTER
- Status last verified
- May 2017
- First submitted
- 7 Apr 2016
- Last updated
- 27 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Feasibility Clinical Trial of Neurostyle Brain Exercise Therapy Towards Enhanced Recovery (nBETTER) for postStroke Arm Paresis
- ClinicalTrials.gov ID
- NCT02765334
- Acronym / sponsor ID
- nBETTER / 2014/01164
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Collaborators
- Institute for Infocomm Research, National University Hospital, Singapore
- Study start
- 28 Dec 2015 (actual)
- Primary completion
- 16 Aug 2017 (actual)
- Study completion
- 16 Aug 2017 (actual)
- First posted
- 6 May 2016 (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.
A feasibility trial of Neurostyle Brain Exercise Therapy Towards Enhanced Recovery (nBETTER) system for Brain Computer Interface (BCI) neurofeedback for rehabilitation of the subacute and chronic hemiplegic upper limb aimed at improving upper limb recovery for subacute to chronic stroke patients.
Detailed description
Stroke remains the 4th cause of death in Singapore and despite advances in neuro-medical care and rehabilitation, 40-50% of stroke survivors are left with permanent neuro-disability and a reduced quality of life. The previous 2 decades has seen exponential leaps in the development of rehabilitation technologies which enhance neuroplasticity and rehabilitation outcome. One of these potentially useful technologies is nBETTER System, was developed by Institute for Infocomm Research, Agency for Science, Technology and Research (A*STAR). nBETTER is a portable, internet-connected device that detects the imagination of movement of stroke-affected limb using a Electroencephalography (EEG)-based Brain-Computer Interface (BCI) thus delivering visually engaging feedback for directed neurofeedback aimed at improving upper limb recovery for subacute to chronic stroke patients. The pilot study aims to recruit 13 patients using a multi centre trial design to investigate nBETTER system feasibility and safety for rehabilitation of subacute to chronic stroke patients with upper limb motor impairment and to determine clinical efficacy, safety and feasibility of such a system when it is delivered with standard occupational therapy.
The investigators primary hypothesis is that nBETTER is a feasible and safe prototype in stroke survivors (> 3 months) with moderate to severe arm impairment (FMMA 10-50). The primary outcome is a gain of 15% in Fugl-Meyer motor scores at 6 weeks after 18 sessions (total of 27 hours) of supervised training by occupational therapists and bioengineers.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility of nBETTER training (60 minutes) with conventional arm therapy (30minutes) for chronic stroke.
| Arm | Type | Receives |
|---|---|---|
| nBETTER and Conventional Therapy | Experimental | Device: nBETTERIntervention: nBetter therapy |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 21-80 years with first-ever clinical stroke diagnosed on CT or MRI brain imaging.
- Stroke duration of 3-24 months.
- Stroke type: ischemic or haemorrhagic
- Fugl-Meyer motor score of the upper limb range from 10-50
- Ability to pay attention and maintain supported sitting for 1.5 hours continuously
Key exclusion criteria (7 listed)
- Recurrent clinical stroke
- Functional status: severe aphasia or inattention, unstable medical conditions which may affect participation (e.g. unresolved sepsis, postural hypotension, end stage renal failure) or anticipated life expectancy of <1 year due to malignancy or neurodegenerative disorder)
- Hemispatial neglect (visual or sensory) or severe visual impairment despite visual aids
- History of epilepsy, severe depression or active psychiatric disorder
- Skull defect or previous cranial surgery as this would affect physical fit of EEG cap interface
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 |
|---|---|---|
| nBETTER60 minutes of nBETTER training followed by 30 minutes of conventional therapy occupational therapy. Total of 18 sessions over 6 weeks. | Device | nBETTER and Conventional Therapy |
Primary outcome
Change in Upper extremity Fugl-Meyer motor score post training
Time frame: Baseline and week 6
As above
5 secondary outcomes
Change in Transcranial Magnetic Stimulation Assessment (TMS)
Time frame: Baseline and week 6
Change in Grip Strength
Time frame: Baseline and week 6
Change in Frenchay Arm Test of Function (FAT)
Time frame: Baseline and week 6
Change in Modified Ashworth Scale score (MAS)
Time frame: Baseline and week 6
Change in Visual Analogue Scale (VAS)
Time frame: Baseline and week 6
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 27 Feb 2018.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Karen S Chua, MBBS, FRCP principal investigator
Tan Tock Seng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nBETTER 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 7 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 27 Feb 2018. 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?
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 extremity Fugl-Meyer motor score post training (time frame: Baseline and week 6). 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 27 Feb 2018.