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

• Sponsor: Beijing Tiantan Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04387474
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Arms: 2
• Actual Duration (Months): 24.7
• Patients Per Site Per Month: 12.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hemiplegia Following Ischemic Stroke	Device: Brain-computer interface; Other: Traditional rehabilitation	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: China National Clinical Research Center for Neurological Diseases
• Actual Study Start Date: May 10, 2020
• Actual Primary Completion Date: Apr 20, 2022
• Actual Study Completion Date: May 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental group brain-computer interface rehabilitation training and traditional rehabilitation training.	Device: Brain-computer interface; brain-computer interface rehabilitation training.; Other: Traditional rehabilitation; traditional rehabilitation training.
Other: Control group traditional rehabilitation training.	Other: Traditional rehabilitation; traditional rehabilitation training.

Outcome Measures

Primary Outcome Measures

1. The improvement of upper limb motor function at 1 month after randomization. [1 month after randomization compared with traditional rehabilitation strategy.]

   Tested by Fugl-Meyer Assessment (FMA) scale.

Secondary Outcome Measures

1. The improvement of upper limb motor function at 3 month after randomization. [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. [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. [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 [1, 3 months after randomization compared with traditional rehabilitation strategy.]

   Tested by Instrumental Activity of Daily living (IDAL).

Other Outcome Measures

1. The changes of brain network properties. [1 month and 3 months after randomization.]

   Evaluated by fMRI before and after rehabilitaion.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Adult subjects (18 years<male or female≤80 years )

2. Ischemic stroke diagnosed by MRI within 1 month before randomization

3. Unilateral upper limb dysfunction with NIHSS score 1-3 at the time of randomization

4. Informed consent signed

Exclusion Criteria:

1. Unable to understand or cooperate because of severe aphasia or cognitive impairment (CDR >0.5) or mental illness

2. A history of epilepsy

3. Sensory disorders or hallucinations

4. Internal carotid artery dissection or thrombolysis

5. Apraxia

6. Agnosia

7. Other diseases that may interfere with motor function

8. Severe cardiopulmonary disease, severe illness, and unstable vital signs

9. Severe balance dysfunction

10. Participating in other clinical trial

11. During pregnancy and lactation

12. The Numerical Rating Scale (NRS) scores of upper extremities>4.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	China National Clinical Research Center for Neurological Diseases	Beijing	Beijing	China	100070

Sponsors and Collaborators

• Beijing Tiantan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Beijing Tiantan Hospital
• ClinicalTrials.gov Identifier: NCT04387474
• Other Study ID Numbers: KY2019-089-02
• First Posted: May 13, 2020
• Last Update Posted: Jul 6, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Beijing Tiantan Hospital: Brain-computer interface; Electric stimulation therapy; Stroke rehabilitation
• Additional relevant MeSH terms: Stroke; Ischemic Stroke; Hemiplegia; Ischemia

Study Results

No Results Posted as of Jul 6, 2022