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

Stroke Clinical Trial

— nBETTER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02765334
• Other study ID #: 2014/01164
• Status: Completed
• Phase: N/A
• First received: April 7, 2016
• Last updated: February 25, 2018
• Start date: December 28, 2015
• Est. completion date: August 16, 2017

Study information

• Verified date: May 2017
• Source: Tan Tock Seng Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: August 16, 2017
• Est. primary completion date: August 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

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

Locations

Country	Name	City	State
Singapore	Tan Tock Seng Hospital	Singapore

Sponsors (3)

Lead Sponsor	Collaborator
Tan Tock Seng Hospital	Institute for Infocomm Research, National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Upper extremity Fugl-Meyer motor score post training	As above	Baseline and week 6
Secondary	Change in Transcranial Magnetic Stimulation Assessment (TMS)	As above	Baseline and week 6
Secondary	Change in Grip Strength	Grip Strength measures hand force in kgf	Baseline and week 6
Secondary	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
Secondary	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
Secondary	Change in Visual Analogue Scale (VAS)	Visual Analogue Scale (VAS) measures pain on a scale from 0 to 10	Baseline and week 6