NCT02765334

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 28, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2016

Completed
29 days until next milestone

First Posted

Study publicly available on registry

May 6, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2017

Completed
Last Updated

February 27, 2018

Status Verified

May 1, 2017

Enrollment Period

1.6 years

First QC Date

April 7, 2016

Last Update Submit

February 25, 2018

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • Change in Upper extremity Fugl-Meyer motor score post training

    As above

    Baseline and week 6

Secondary Outcomes (5)

  • 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

Study Arms (1)

nBETTER and Conventional Therapy

EXPERIMENTAL

Intervention: nBetter therapy

Device: nBETTER

Interventions

nBETTERDEVICE

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

nBETTER and Conventional Therapy

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tan Tock Seng Hospital

Singapore, 308433, Singapore

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Karen S Chua, MBBS, FRCP

    Tan Tock Seng Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Model Details: Feasibility of nBETTER training (60 minutes) with conventional arm therapy (30minutes) for chronic stroke.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2016

First Posted

May 6, 2016

Study Start

December 28, 2015

Primary Completion

August 16, 2017

Study Completion

August 16, 2017

Last Updated

February 27, 2018

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)