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Completed

NCT Number: NCT04387474

The Effectiveness of Rehabilitation Training Based on Brain-computer Interface Technology to Improve the Upper Limb Motor Function of Ischemic Stroke.

To evaluate the effectiveness and safety of rehabilitation training based on brain-computer interface in improving the upper motor function, self-care ability in daily life and quality of life in patients with ischemic stroke. This study adopts centralized uniform random 1:1 grouping, subjects will be randomly assigned to the experimental group and the control group. Randomization schemes are generated by statistical professionals using SAS software.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China National Clinical Research Center for Neurological Diseases

Beijing, Beijing Municipality, 100070, China

About this study

Brain computer interface(BCI) is a noninvasive nervous system intervention. As a new method, it is applied in rehabilitation by stimulating peripheral nerve, such as motor, vibration, sensory, in combination with other stimulations, such as transcranial magnetic stimulation, transcranial electrical stimulation, etc.

In traditional rehabilitation therapy, hand-holding training is completed by physical therapist. Rehabilitation robot is also used for auxiliary training. BCI therapy will stimulate patients to take part in rehabilitation training more actively and obtain better effects on the rehabilitation of stroke.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult subjects (18 years<male or female≤80 years )
  • Ischemic stroke diagnosed by MRI within 1 month before randomization
  • Unilateral upper limb dysfunction with NIHSS score 1-3 at the time of randomization
  • Informed consent signed

Exclusion criteria

  • Unable to understand or cooperate because of severe aphasia or cognitive impairment (CDR >0.5) or mental illness
  • A history of epilepsy
  • Sensory disorders or hallucinations
  • Internal carotid artery dissection or thrombolysis
  • Apraxia
  • Agnosia
  • Other diseases that may interfere with motor function
  • Severe cardiopulmonary disease, severe illness, and unstable vital signs
  • Severe balance dysfunction
  • Participating in other clinical trial
  • During pregnancy and lactation
  • The Numerical Rating Scale (NRS) scores of upper extremities>4.

Treatment and study plan

Brain-Computer Interface

Device

brain-computer interface rehabilitation training.

traditional rehabilitation

Other

traditional rehabilitation training.

Primary outcomes

  1. The improvement of upper limb motor function at 1 month after randomization.

    Time frame: 1 month after randomization compared with traditional rehabilitation strategy.

    Tested by Fugl-Meyer Assessment (FMA) scale.

Secondary outcomes

  1. The improvement of upper limb motor function at 3 month after randomization.

    Time frame: 3 months after randomization compared with traditional rehabilitation strategy .

    Tested by Fugl-Meyer Assessment (FMA) scale.

  2. The improvement of upper limb motor function at 1, 3 month after randomization.

    Time frame: 1, 3 months after randomization compared with traditional rehabilitation strategy.

    Tested by Action Research Arm Test (ARAT), The Wolf Motor Function Test (WMFT).

  3. The improvement in muscle tone at 1, 3 month after randomization.

    Time frame: 1, 3 months after randomization compared with traditional rehabilitation strategy.

    Tested by the Modified Ashworth scale (MAS).

  4. The improvement of patients' ability to take care of themselves in daily life

    Time frame: 1, 3 months after randomization compared with traditional rehabilitation strategy.

    Tested by Instrumental Activity of Daily living (IDAL).

Other outcomes

  1. The changes of brain network properties.

    Time frame: 1 month and 3 months after randomization.

    Evaluated by fMRI before and after rehabilitaion.

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

China National Clinical Research Center for Neurological Diseases

Acronym: REBUILT

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 13, 2020
Registry last updated
Feb 21, 2024

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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