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A Study of Neurostyle Brain Exercise Therapy Towards Enhanced Recovery (nBETTER) for Stroke (nBETTER)

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ClinicalTrials.gov Identifier: NCT02765334
Recruitment Status : Completed
First Posted : May 6, 2016
Last Update Posted : February 27, 2018
Sponsor:
Collaborators:
Institute for Infocomm Research
National University Hospital, Singapore
Information provided by (Responsible Party):
Tan Tock Seng Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Stroke Device: nBETTER Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Feasibility of nBETTER training (60 minutes) with conventional arm therapy (30minutes) for chronic stroke.
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: A Pilot Feasibility Clinical Trial of Neurostyle Brain Exercise Therapy Towards Enhanced Recovery (nBETTER) for postStroke Arm Paresis
Actual Study Start Date : December 28, 2015
Actual Primary Completion Date : August 16, 2017
Actual Study Completion Date : August 16, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: nBETTER and Conventional Therapy
Intervention: nBetter therapy
Device: nBETTER
60 minutes of nBETTER training followed by 30 minutes of conventional therapy occupational therapy. Total of 18 sessions over 6 weeks.




Primary Outcome Measures :
  1. Change in Upper extremity Fugl-Meyer motor score post training [ Time Frame: Baseline and week 6 ]
    As above


Secondary Outcome Measures :
  1. Change in Transcranial Magnetic Stimulation Assessment (TMS) [ Time Frame: Baseline and week 6 ]
    As above

  2. Change in Grip Strength [ Time Frame: Baseline and week 6 ]
    Grip Strength measures hand force in kgf

  3. Change in Frenchay Arm Test of Function (FAT) [ Time Frame: Baseline and week 6 ]

    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)

  4. Change in Modified Ashworth Scale score (MAS) [ Time Frame: Baseline and week 6 ]
    Modified Ashworth Scale score (MAS) measure spasticity of wrist and hand finger flexors on a scale from 0 to 4

  5. Change in Visual Analogue Scale (VAS) [ Time Frame: Baseline and week 6 ]
    Visual Analogue Scale (VAS) measures pain on a scale from 0 to 10



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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged 21-80 years with first-ever clinical stroke diagnosed on CT or MRI brain imaging.
  2. Stroke duration of 3-24 months.
  3. Stroke type: ischemic or haemorrhagic
  4. Fugl-Meyer motor score of the upper limb range from 10-50
  5. Ability to pay attention and maintain supported sitting for 1.5 hours continuously
  6. Able to give own consent and understand simple instructions
  7. Fulfils BCI resting brain states on initial screening.

Exclusion Criteria:

  1. Recurrent clinical stroke
  2. 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)
  3. Hemispatial neglect (visual or sensory) or severe visual impairment despite visual aids
  4. History of epilepsy, severe depression or active psychiatric disorder
  5. Skull defect or previous cranial surgery as this would affect physical fit of EEG cap interface
  6. 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.
  7. TMS contraindications: females with reproductive potential not on reliable contraception; pregnancy; cardiac pacemakers; orthodontics (braces); metal implants.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02765334


Locations
Singapore
Tan Tock Seng Hospital
Singapore, Singapore, 308433
Sponsors and Collaborators
Tan Tock Seng Hospital
Institute for Infocomm Research
National University Hospital, Singapore
Investigators
Principal Investigator: Karen S Chua, MBBS, FRCP Tan Tock Seng Hospital

Responsible Party: Tan Tock Seng Hospital
ClinicalTrials.gov Identifier: NCT02765334     History of Changes
Other Study ID Numbers: 2014/01164
First Posted: May 6, 2016    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases