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Completed

NCT Number: NCT02323061

Brain Computer Interface（BCI） System for Stroke Rehabilitation

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Biomedical Engineering, The Chinese University of Hong Kong

Hong Kong

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

BCI using EEG signals

Procedure

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.

Primary outcomes

  1. FMA-UE

    Time frame: 6-month followup

  2. ARAT

    Time frame: 6-month followup

Secondary outcomes

  1. MAS

    Time frame: 6-month followup

  2. MRI

    Time frame: 6-month followup

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 23, 2014
Registry last updated
Sep 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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