A Pilot Feasibility Clinical Trial of Neurostyle Brain Exercise Therapy Towards Enhanced Recovery (nBETTER) for postStroke Arm Paresis

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

Sponsors

Lead sponsor: Tan Tock Seng Hospital

Collaborator: Institute for Infocomm Research
National University Hospital, Singapore

Source 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.

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.

Overall Status Completed
Start Date December 28, 2015
Completion Date August 16, 2017
Primary Completion Date August 16, 2017
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in Upper extremity Fugl-Meyer motor score post training Baseline and week 6
Secondary Outcome
Measure Time Frame
Change in Transcranial Magnetic Stimulation Assessment (TMS) Baseline and week 6
Change in Grip Strength Baseline and week 6
Change in Frenchay Arm Test of Function (FAT) Baseline and week 6
Change in Modified Ashworth Scale score (MAS) Baseline and week 6
Change in Visual Analogue Scale (VAS) Baseline and week 6
Enrollment 13
Condition
Intervention

Intervention type: Device

Intervention name: nBETTER

Description: 60 minutes of nBETTER training followed by 30 minutes of conventional therapy occupational therapy. Total of 18 sessions over 6 weeks.

Arm group label: nBETTER and Conventional Therapy

Eligibility

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.

Gender: All

Minimum age: 21 Years

Maximum age: 80 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Karen S Chua, MBBS, FRCP Principal Investigator Tan Tock Seng Hospital
Location
facility Tan Tock Seng Hospital
Location Countries

Singapore

Verification Date

May 2017

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: nBETTER and Conventional Therapy

Arm group type: Experimental

Description: Intervention: nBetter therapy

Acronym nBETTER
Patient Data No
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Feasibility of nBETTER training (60 minutes) with conventional arm therapy (30minutes) for chronic stroke.

Primary purpose: Device Feasibility

Masking: None (Open Label)

Source: ClinicalTrials.gov