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

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: nBETTER

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
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 308433
    • Tan Tock Seng Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Upper extremity Fugl-Meyer motor score post training	As above	Baseline and week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Transcranial Magnetic Stimulation Assessment (TMS)	As above	Baseline and week 6
Change in Grip Strength	Grip Strength measures hand force in kgf	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)	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	Baseline and week 6
Change in Visual Analogue Scale (VAS)	Visual Analogue Scale (VAS) measures pain on a scale from 0 to 10	Baseline and week 6

Collaborators and Investigators

• Sponsor: Tan Tock Seng Hospital
• Collaborators: National University Hospital, Singapore; Institute for Infocomm Research
• Investigators: Principal Investigator: Karen S Chua, MBBS, FRCP, Tan Tock Seng Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2015
• Primary Completion (Actual): August 16, 2017
• Study Completion (Actual): August 16, 2017

Study Registration Dates

• First Submitted: April 7, 2016
• First Submitted That Met QC Criteria: May 4, 2016
• First Posted (Estimate): May 6, 2016

Study Record Updates

• Last Update Posted (Actual): February 27, 2018
• Last Update Submitted That Met QC Criteria: February 25, 2018
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 2014/01164

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO