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

Recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Conventional therapy Other
    Intervention Desc: Conventional Therapy includes: Stretching and tone management of the upper limb Weight bearing exercises Facilitated movement and self-care training (activities if daily living) Percutaneous functional electrical stimulation Arm ergometry by arm bicycles Grip strength training and strengthening
    ARM 1: Kind: Experimental
    Label: nBETTER and Conventional Therapy
    Description: Intervention: nBetter therapy
  • NBETTER Device
    Intervention Desc: 60 minutes of nBETTER training followed by 30 minutes of conventional therapy occupational therapy. Total of 18 sessions over 6 weeks.
    ARM 1: Kind: Experimental
    Label: nBETTER and Conventional Therapy
    Description: Intervention: nBetter therapy

Trial Design

  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change in Upper extremity Fugl-Meyer motor score post training Baseline and week 6 No
Secondary Change in Transcranial Magnetic Stimulation Assessment (TMS) Baseline and week 6 No
Secondary Change in Grip Strength Baseline and week 6 No
Secondary Change in Frenchay Arm Test of Function (FAT) Baseline and week 6 No
Secondary Change in Modified Ashworth Scale score (MAS) Baseline and week 6 No
Secondary Change in Visual Analogue Scale (VAS) Baseline and week 6 No

Sponsors