NCT02323061

Brief Summary

A BCI system for stroke subjects will be designed in an attempt to train the motor-related areas in their brains responsible for hand open/close function. A robot hand will be used and controlled by the system in real time based on EEG pattern for identification of motion intention for hand movements in the motor cortex. A randomized controlled trial study design will be adopted. All subjects will be assessed by clinical assessments including FMA and neuroimaging assessments using multimodal MR techniques before and after the training to evaluate training effectiveness.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started May 2015

Typical duration for not_applicable stroke

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

First Submitted

Initial submission to the registry

December 18, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 23, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

September 18, 2017

Status Verified

September 1, 2017

Enrollment Period

2.1 years

First QC Date

December 18, 2014

Last Update Submit

September 15, 2017

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

  • FMA-UE

    6-month followup

  • ARAT

    6-month followup

Secondary Outcomes (2)

  • MAS

    6-month followup

  • MRI

    6-month followup

Study Arms (3)

BCI-robot (I)

EXPERIMENTAL

EEG guided training based on ipsilesional EEG signals; Training for 20 sessions

Procedure: BCI using EEG signals

BCI-robot (IC)

EXPERIMENTAL

EEG guided training based on both ipsilesional and contralesional EEG signals; Training for 20 sessions

Procedure: BCI using EEG signals

robot

PLACEBO COMPARATOR

Training for 20 sessions

Procedure: BCI using EEG signals

Interventions

BCI using EEG signalsPROCEDURE

A robot hand will be used and controlled by the system in real time based on EEG pattern for identification of motion intention for hand movements in the cortex.

BCI-robot (I)BCI-robot (IC)robot

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sufficient cognition to follow simple instructions, as well as understand the content and purpose of the experiment;
  • Subcortical ischemic lesion within the territory of the middle cerebral artery;
  • Have moderate to severe motor disability at the paretic upper limb (assessed by Fugl-Meter Assessment (FMA), Modified Ashworth Score of fingers (MAS), and Action Research Arm Test(ARAT)).
  • Hemiparesis resulting from a single unilateral lesion of the brain with onset at least 6 months before data collection.

You may not qualify if:

  • Severe hand spasticity, open hand wound or hand deformity;
  • Visual field deficits;
  • Aphasia, neglect, and apraxia,
  • Participation in any therapeutic treatment ("outside therapy") performed with the paralyzed arm during the planned study - including baseline and follow up.
  • History of alcohol, drug abuse or epilepsy,
  • Bilateral infracts,
  • Uncontrolled medical problems,
  • Serious cognitive deficits,
  • Other MRI contraindications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Biomedical Engineering, The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (2)

  • Lau CCY, Yuan K, Wong PCM, Chu WCW, Leung TW, Wong WW, Tong RKY. Modulation of Functional Connectivity and Low-Frequency Fluctuations After Brain-Computer Interface-Guided Robot Hand Training in Chronic Stroke: A 6-Month Follow-Up Study. Front Hum Neurosci. 2021 Jan 20;14:611064. doi: 10.3389/fnhum.2020.611064. eCollection 2020.

    PMID: 33551777DERIVED

  • Yuan K, Wang X, Chen C, Lau CC, Chu WC, Tong RK. Interhemispheric Functional Reorganization and its Structural Base After BCI-Guided Upper-Limb Training in Chronic Stroke. IEEE Trans Neural Syst Rehabil Eng. 2020 Nov;28(11):2525-2536. doi: 10.1109/TNSRE.2020.3027955. Epub 2020 Nov 6.

    PMID: 32997632DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 18, 2014

First Posted

December 23, 2014

Study Start

May 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

September 18, 2017

Record last verified: 2017-09

Locations

HK(1)