Clinical trial NCT05778448: BCI for Hemiparetic Upper Extremities in Patients Due to Stroke
Official title: Brain-computer Interface (BCI) Based Closed-loop Training for Hemiparetic Upper Extremities in Patients Due to Stroke: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Brain Computer Interface
Keywords: Stroke
Brain Computer Interface
Neurorehabilitation
Event Related Desynchronization
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Non-invasive brain-computer interface (BCI) technology is one of the new training approaches to achieve motor restoration through a closed-loop system from brain activity through event-related desynchronization (ERD) after motor imagery (MI) or movement attempt to peripheral feedback triggered by an external hepatic device. Often, it is unclear whether the BCI intervention itself or the assistance of the external device leads to neural responses and functional gains.

This study adopts a closed-loop BCI system involving ERD induced by MI. Functional electrical stimulation (FES) and virtual reality (VR) are simultaneously delivered as feedback. The aim is to investigate the efficacy of closed-loop BCI training combined with FES and VR on the recovery of the hemiparetic upper extremity of individuals with chronic stroke.

Chronic stroke survivors are being recruited and randomly allocated into 3 groups: (1) BCI-FES-VR - participants look at an external screen displaying the VR avatar participant's arms while performing wrist dorsiflexion MI in random order (left or right). The BCI system detects the ERD of the motor area corresponding to correct MI. Then, visual feedback with the VR and motor-tactile feedback with the discharge of the FES is delivered; (2) BCI-FES - same procedure as group 1, but the difference is that the participant's hands replace the VR system; (3) BCI-VR - same procedure as group 1, but the FES is removed. Each session requires 240 MI trials with a training duration of 10 sessions in a 3-week interval.

Motor and MI assessments are being conducted at post-assessment and at a 3-week follow-up.

The findings of this study will provide significant new information regarding neurophysiological motor relearning mechanisms, which could inform the development and evaluation of BCI-based treatment for individuals with stroke and impact the field of translational neuroscience.


Eligibility criteria: Inclusion Criteria:

1. Have a diagnosis of ischemic or hemorrhagic stroke to unilateral hemisphere, confirmed by neuroimaging examinations, i.e., brain CT or MRI;
2. Chronic phase of stroke, i.e., time after stroke onset more than 6 months;
3. Between 18 and 64 years old;
4. With severe to moderate levels of hemiparetic upper limb impairment due to stroke, i.e., from levels 1 to 4 in the Functional Test for the Hemiplegic Upper Extremity (FTHUE)
5. Able to give informed written consent to participate in the study.

Exclusion Criteria:

1. Previous diagnosis of any neurological disease excluding stroke;
2. Presence of any sign of cognitive problems (Abbreviated Mental Test \< 6)
3. Modified Ashworth score \> 2 in wrist extensor muscle in the hemiparetic upper extremity after stroke (Bohannon and Smith, 1987) or with severe pain that hinders upper extremity movement
4. With other notable impairments of the upper extremity not caused by stroke (e.g., fracture, Rheumatoid Arthritis, or congenital deformity, etc.)

Primary outcomes:
measure: Change from Baseline Fugl-Meyer Assessment - Upper Extremity (FMA-UE)
timeFrame: Baseline, Post-intervention and 3-week Follow-up (through study completion, an average of 6 weeks)
measure: Change from Baseline Action Research Arm Test (ARAT)
timeFrame: Baseline, Post-intervention and 3-week Follow-up (through study completion, an average of 6 weeks)
Secondary outcomes:
measure: Revised Purdue Spatial Visualization Test (Revised PSVT:R)
timeFrame: Baseline, Post-intervention and 3-week Follow-up (through study completion, an average of 6 weeks)
measure: Kinesthetic and Visual Imagery Questionnaire (KVIQ)
timeFrame: Baseline, Post-intervention and 3-week Follow-up (through study completion, an average of 6 weeks)
measure: Hand grip strength test
timeFrame: Baseline, Post-intervention and 3-week Follow-up (through study completion, an average of 6 weeks)
measure: Motor Activity Log (MAL)
timeFrame: Baseline, Post-intervention and 3-week Follow-up (through study completion, an average of 6 weeks)
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Polytechnic University, Department of Rehabilitation Sciences
Study officials:
References:
citation: Bai Z, Fong KNK, Zhang JJ, Chan J, Ting KH. Immediate and long-term effects of BCI-based rehabilitation of the upper extremity after stroke: a systematic review and meta-analysis. J Neuroeng Rehabil. 2020 Apr 25;17(1):57. doi: 10.1186/s12984-020-00686-2.
citation: Sitaram R, Ros T, Stoeckel L, Haller S, Scharnowski F, Lewis-Peacock J, Weiskopf N, Blefari ML, Rana M, Oblak E, Birbaumer N, Sulzer J. Closed-loop brain training: the science of neurofeedback. Nat Rev Neurosci. 2017 Feb;18(2):86-100. doi: 10.1038/nrn.2016.164. Epub 2016 Dec 22.
citation: Cruz Gonzalez, P., Fong, K. N., & Brown, T. (2022). Closed-Loop Brain-Computer Interface Training for Hemiparetic Upper Extremities in Patients with Chronic Stroke: A randomized control study [Abstract]. Neurorehabilitation and Neural Repair. Poster presentation at the 12th World Congress for Neurorehabilitation, December 2022, Vienna, Austria.