NCT02323074

Brief Summary

In this project we will design a control algorithm to identify the focalized motor-related clusters for hand function on each stroke patient. A real-time feedback will control the robotic hand when motor imagery is successfully identified. Finally, the focalized BCI-robot training will be compared in a randomized controlled trial to evaluate the training effectiveness and changes in the EEG patterns.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2014

Completed
12 months until next milestone

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
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

July 6, 2016

Status Verified

July 1, 2016

Enrollment Period

3.9 years

First QC Date

December 18, 2014

Last Update Submit

July 4, 2016

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • FMA-UE

    3-month followup

Secondary Outcomes (2)

  • ARAT

    3-month followup

  • MAS

    3-month followup

Study Arms (3)

fBCI-robot

EXPERIMENTAL

focalized BCI-robot hand training

Procedure: Brain Computer Interface

gBCI-robot

EXPERIMENTAL

generalized BCI-robot hand training

Procedure: Brain Computer Interface

sham-BCI

SHAM COMPARATOR

Sham BCI

Procedure: Brain Computer Interface

Interventions

Brain Computer InterfacePROCEDURE
fBCI-robotgBCI-robotsham-BCI

Eligibility Criteria

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

You may qualify if:

  • (1) sufficient cognition to follow simple instructions, as well as understand the content and purpose of the experiment (Mini-Mental State Examination (MMSE) score\>25) ; (2) subcortical location of the ischemic lesion within the territory of the middle cerebral artery; (3) have moderate to severe motor disability at the paretic upper limb (assessed by Fugl-Meyer Assessment (FMA), Modified Ashworth Score of fingers (MAS), and Action Research Arm Test (ARAT))

You may not qualify if:

  • (1) severe hand spasticity, open hand wound or hand deformity; (2) visual field deficits; (3) aphasia, neglect, and apraxia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Biomedical Engineering, Dept Electronic Engineering

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Brain-Computer Interfaces

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electrical Equipment and SuppliesEquipment and Supplies

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

January 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

July 6, 2016

Record last verified: 2016-07

Locations

HK(1)