Ignite Creation Date:
2024-05-06 @ 6:01 PM
Last Modification Date:
2024-10-26 @ 2:39 PM
Study NCT ID:
NCT05511207
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2022-08-12
Brief Title:
Clinical Validation of a Hybrid BCI-controlled FES for Upper Limb Rehabilitation After Stroke
Sponsor:
Donatella Mattia
Organization:
IRCCS Fondazione Santa Lucia
Study Overview
Official Title:
RECOMmENceR RE-establishing COrtico Muscular COMunication to ENhance Recovery Clinical Validation of BCI-controlled Functional Electrical Stimulation for Upper Limb Rehabilitation After Stroke
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RECOMMENCER
Brief Summary:
The RECOMMENCER project aims at developing and testing a novel hybrid Brain Computer Interface device based on cortico-muscular connectivity that will be employed to activate Functional Electrical Stimulation FES of upper limb muscles After the technical implementation of the device and its preliminary testing on healthy subject the investigators will evaluate the effects of a 1 month training with the device RECOM on post-stroke patients undergoing standard rehabilitation add-on The proposed intervention will be compared with an active physiotherapy training including FES CTRL which will be focused on upper limb with similar intensity as the target intervention also delivered in add-on
Detailed Description:
Brain-Computer Interface BCI systems for upper limb rehabilitation have proven some efficacy in the context of several randomized controlled trials RCT Such systems rely on the possibility reinforce motor-related brain activity derived eg from electroencephalography EEG harnessing neuroplasticity phenomena ultimately leading to favorable motor outcome Up to now no hybrid BCI hBCI has been tested successfully for this purpose in a clinical trial Hybrid BCIs include signals from the periphery most commonly muscles via surface electromyography EMG and are usually employed to improve BCI performances In a rehabilitative context the investigators aim to employ EMG signals to characterize common post-stroke abnormalities spasticity co-contractions motor overflow and possibly include those in a novel hBCI paradigm to promote both volitional control EEG over upper limb movement and close to normal muscular activation EMG To do so the investigators propose cortico-muscular coherence CMC as a hybrid feature for BCI control CMC is a measure of EEG-EMG synchronization during movement and has been described extensively in post-stroke patients in relation to their residual motor ability With respect to previous literature the proposed approach foresees the estimation of CMC as a multimodal integrated EEG-EMG network comprising multiple EEG electrodes over the scalp bilaterally and several upper limb muscles bilaterally so as to capture the above mentioned motor abnormalities eg abnormal recruitment of non-target muscles The investigators have already tested such feature on healthy subjects and stroke patients offline and verified its capability to detect upper limb movements online studies published andor submitted see references An already available BCI prototype was adapted with the parameters derived from such offline studies see references The RECOM intervention will be validated within a RCT single blinded for evaluators on stroke patients undergoing rehabilitation add-on Before and after the intervention all patients will undergo an extensive clinical evaluation see outcome measures and neurophysiological assessment The latter will consist in a high density EEG-EMG recording during simplecomplex upper limb movements The recording will include a cinematic analysis inertial measurement units - IMUs The investigators hypothesize a better functional motor outcome in the affected upper limb for the RECOM group which will be described by means of common clinicalfunctional scales combined with EEGEMG and cinematic evaluation Furthermore aspects related to acceptability and usability of the novel system will be evaluated In detail mood motivation and satisfaction will be evaluated before mood motivation and after satisfaction each training session by means of Visual Analogue Scales workload will be evaluated at the end of second and last training session by means of the Nasa-Task Load Index
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GR1874 | OTHER | Hsantalucia | None |