Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06503484
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-10
Brief Title:
Utilizing a Brain-Computer Interface for Observational Imitation Training to Enhance Upper Limb Motor Recovery Post-Stroke A Randomized Controlled Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Utilizing a Brain-Computer Interface for Observational Imitation Training to Enhance Upper Limb Motor Recovery Post-Stroke A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objectives 1 To compare the effects of closed-loop brain-computer interface BCI driven observational imitation training versus sham BCI open-loop observational imitation training on improving upper limb motor functions in patients with stroke 2 To investigate whether stroke patients receiving closed-loop training exhibit higher activation levels in the mirror neurons measured by event-related desynchronization ERD compared to those receiving open-loop training
Hypothesis to be tested The closed-loop training is more effective than open-loop training in improving upper limb motor outcomes and there is an increase in the mirror neurons activity in those receiving closed-loop training
Design and subjects A randomized controlled trial with 50 participants with stroke
Study instruments Functional near-infrared spectroscopy fNIRS-based BCI and electroencephalography EEG
Interventions In the BCI training participants will engage in kinesthetic motor imagery When the M1 activation level recorded by fNIRS surpasses a predefined threshold participants will receive visual feedback to guide them to imitate the movement However for participants in the sham BCI group the visual feedback will be given based on the brain activity of another participant in the real BCI group ie yoked sham neurofeedback Both types of training consist of ten sessions
Main outcome measures Upper limb motor tests and the activity of mirror neurons measured by sensorimotor ERD using EEG
Data analysis Analysis of variance and correlation Expected results The closed-loop BCI-driven observational imitation training is more effective than sham BCI open-loop training on enhancing hemiplegic upper limb functions and the activation of the mirror neurons in patients after stroke
Hypothesis to be tested The closed-loop training is more effective than open-loop training in improving upper limb motor outcomes and there is an increase in the mirror neurons activity in those receiving closed-loop training
Design and subjects A randomized controlled trial with 50 participants with stroke
Study instruments Functional near-infrared spectroscopy fNIRS-based BCI and electroencephalography EEG
Interventions In the BCI training participants will engage in kinesthetic motor imagery When the M1 activation level recorded by fNIRS surpasses a predefined threshold participants will receive visual feedback to guide them to imitate the movement However for participants in the sham BCI group the visual feedback will be given based on the brain activity of another participant in the real BCI group ie yoked sham neurofeedback Both types of training consist of ten sessions
Main outcome measures Upper limb motor tests and the activity of mirror neurons measured by sensorimotor ERD using EEG
Data analysis Analysis of variance and correlation Expected results The closed-loop BCI-driven observational imitation training is more effective than sham BCI open-loop training on enhancing hemiplegic upper limb functions and the activation of the mirror neurons in patients after stroke
Detailed Description:
Objectives 1 To compare the effects of closed-loop brain-computer interface BCI driven observational imitation training versus sham BCI open-loop observational imitation training on improving upper limb motor functions in patients with stroke 2 To investigate whether stroke patients receiving closed-loop training exhibit higher activation levels in the mirror neurons measured by event-related desynchronization ERD compared to those receiving open-loop training
Hypothesis to be tested The closed-loop training is more effective than open-loop training in improving upper limb motor outcomes and there is an increase in the mirror neurons activity in those receiving closed-loop training
Design and subjects A randomized controlled trial with 50 participants with stroke
Study instruments Functional near-infrared spectroscopy fNIRS-based BCI and electroencephalography EEG
Interventions In the BCI training participants will engage in kinesthetic motor imagery When the M1 activation level recorded by fNIRS surpasses a predefined threshold participants will receive visual feedback to guide them to imitate the movement However for participants in the sham BCI group the visual feedback will be given based on the brain activity of another participant in the real BCI group ie yoked sham neurofeedback Both types of training consist of ten sessions
Main outcome measures Upper limb motor tests and the activity of mirror neurons measured by sensorimotor ERD using EEG
Data analysis Analysis of variance and correlation Expected results The closed-loop BCI-driven observational imitation training is more effective than sham BCI open-loop training on enhancing hemiplegic upper limb functions and the activation of the mirror neurons in patients after stroke
Hypothesis to be tested The closed-loop training is more effective than open-loop training in improving upper limb motor outcomes and there is an increase in the mirror neurons activity in those receiving closed-loop training
Design and subjects A randomized controlled trial with 50 participants with stroke
Study instruments Functional near-infrared spectroscopy fNIRS-based BCI and electroencephalography EEG
Interventions In the BCI training participants will engage in kinesthetic motor imagery When the M1 activation level recorded by fNIRS surpasses a predefined threshold participants will receive visual feedback to guide them to imitate the movement However for participants in the sham BCI group the visual feedback will be given based on the brain activity of another participant in the real BCI group ie yoked sham neurofeedback Both types of training consist of ten sessions
Main outcome measures Upper limb motor tests and the activity of mirror neurons measured by sensorimotor ERD using EEG
Data analysis Analysis of variance and correlation Expected results The closed-loop BCI-driven observational imitation training is more effective than sham BCI open-loop training on enhancing hemiplegic upper limb functions and the activation of the mirror neurons in patients after stroke
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None