Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06179745
Status:
RECRUITING
Last Update Posted:
2023-12-22
First Post:
2023-11-30
Brief Title:
BCI Driving FES and Hand Orthosis for Upper Limb Rehabilitation in Chronic Stroke
Sponsor:
University of Essex
Organization:
University of Essex
Study Overview
Official Title:
Study of Functional Electrical Stimulation With Assistive Support Driven by a Brain-Computer Interface on the Upper Limb Rehabilitation of Chronic Stroke Patients
Status:
RECRUITING
Status Verified Date:
2023-12
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:
None
Brief Summary:
Multi-center randomized sham-controlled double-blind longitudinal experimental clinical study to investigate functional recovery effects on the upper limb in chronic stroke patients and the accompanying neural plasticity mechanisms after the application of a brain-computer interface BCI-driven functional electrical stimulation FES therapy supported by an assistive device hand orthosis All the equipment used during the study will be applied in compliance with the indications and methods of use for which it is authorized Therefore the results will not extend the indications for the use of the equipment and will not explicitly target industrial development The study is non-profit and is aimed at improving clinical practice The study involves two clinical centers The promoting center is the Vipiteno Neurorehabilitation Department Italy The aggregate experimentation center is the Neurology Department of Hochzirl Hospital Austria The University of Essex United Kingdom is the technology provider and data analysis center
Detailed Description:
This study will investigate whether the combination of FES and an active orthosis assisting the execution of reach-to-grasp and release functional arm movements triggered by a non-invasive EEG-based BCI can promote clinically relevant functional recovery of the upper limb in hemiplegic chronic stroke patients
The BCI detects sensorimotor rhythms SMRs associated with the motor intent of the corresponding attempted movements
In the study group only when BCI detects sensorimotor rhythms SMRs associated with motor intent the assistive devices are triggered
In the control group the assistive devices are triggered randomly decoupled from the entrained cortical activity
Similarly to previous BCI-based interventions the main rationale of the study is that the BCI may transform the FES and orthosis-based therapies and augment their efficacy by restoring the intention-action-perception loop and the contingency between efferent motor commands and afferent sensory feedback In order to specifically study the contribution of the BCI isolated from the main confounds a sham control which preserves FES and orthotic support and only removes blind to both the participants and the therapists the timely coupling of stimulation to suitable SMR EEG activity is preferred over other control candidates conventional therapies no therapy other placebo approaches
Unlike most previous BCI-based interventions a more complex functional movement of the upper limb is selected which further involves object manipulation targeting larger clinical effect and higher impact in terms of Activities of Daily Living ADL Further probing on the hypothesis that richer feedback may account for larger benefits the FES is complemented with a concurrently triggered active orthosis meant to smooth the grasping movement pattern and deliver more accurate proprioceptive feedback
Next to the main hypothesis of verifying the added value of the BCI component in terms of functional recovery but very importantly pre- post-intervention and follow-up assessments with several Transcranial Magnetic Stimulation TMS-based protocols and high-density EEG will serve so that this study takes a closer look on the intracortical and corticospinal tract plasticity mechanisms accompanying the therapy
The choice of studying a chronic stroke population is motivated by the ensemble of results acquired in previous BCI-based trials which suggest larger efficacy in this group
Objective The main objective of this study is to show that a combined FES and orthotic-assistance intervention leads to significantly better in the statistical sense functional improvement of the upper limb indexed with the Fugl-Meyer Assessment FMA scale for the upper limb FMA-UE when driven by an SMR-based BCI compared to a sham controller and that recovery can be lasting and clinically relevant
The hypothesized outcome upon study completion is a significant interaction between the within-subject factor time pre- and post-intervention and the between-subject factor Group BCI vs Sham when performing a mixed-design ANOVA on the studys primary outcome Additionally the BCI group is expected to yield significantly higher primary outcome values post-intervention compared to baseline with suitable post-hoc testing This difference should also exceed what is considered the clinically relevant threshold for chronic stroke samples The BCI group should ideally also be significantly higher in terms of primary outcome compared to the Sham group at the post-intervention and follow-up time points but not at baseline pre-intervention assessment It is a necessary prerequisite for confirming our hypothesis that at least the difference with respect to the primary outcome between post- and pre-intervention sessions is significantly larger in the BCI arm Deriving similar effects with respect to the defined secondary clinical outcomes especially those related to ADL is desirable
The secondary but of critical importance to the scientific question posed objective of this study is to demonstrate that greater functional recovery in the BCI group is associated with activity-dependent neural plasticity phenomena taking place or being profound only within this group The effects of the proposed therapy on motor cortex plasticity and Cortico-Spinal Tract CST excitability will be evaluated pre- and post-intervention as well as at follow-up The excitability of the primary motor cortex and of the corticospinal projections will be indexed with Motor Evoked Potential MEP amplitude and latency resting and active motor threshold RMT AMT after single-pulse TMS and with the intracortical inhibition and facilitation paradigm to paired-pulse TMS studied in the first dorsal interosseus FDI muscle or in more proximal muscles in case of lack of FDI-MEPs eg extensor carpi radialis ECR or flexor digitorum superficialis FDS
The synaptic plasticity of the motor cortex will be assessed through the modulation of MEP amplitude after the rapid paired associative stimulation rPAS protocol Changes in motor cortex plasticity and excitability are expected to follow the same trend as outlined above for the primary clinical outcome and additionally post-pre differences are anticipated to significantly correlate with the corresponding primary outcome differences for each individual participant both within each group and especially when pulling all subjects together It is also assumed that the same effects will be observed for EEG correlates eg functional connectivity within or across motor premotor and sensory areas of the two hemispheres event-related synchronizationdesynchronization ERDERS etc of motor attempt using pre- and post-intervention screening sessions as well as analyzing the EEG data of the therapeutic sessions
The possibility of Diffusion Tensor Imaging where patients perform similar reach-and-grasp movements inside the scanner to more profoundly study structural plasticity pre- and post-intervention will be pursued for eligible patients that agree to undergo this procedure
The BCI detects sensorimotor rhythms SMRs associated with the motor intent of the corresponding attempted movements
In the study group only when BCI detects sensorimotor rhythms SMRs associated with motor intent the assistive devices are triggered
In the control group the assistive devices are triggered randomly decoupled from the entrained cortical activity
Similarly to previous BCI-based interventions the main rationale of the study is that the BCI may transform the FES and orthosis-based therapies and augment their efficacy by restoring the intention-action-perception loop and the contingency between efferent motor commands and afferent sensory feedback In order to specifically study the contribution of the BCI isolated from the main confounds a sham control which preserves FES and orthotic support and only removes blind to both the participants and the therapists the timely coupling of stimulation to suitable SMR EEG activity is preferred over other control candidates conventional therapies no therapy other placebo approaches
Unlike most previous BCI-based interventions a more complex functional movement of the upper limb is selected which further involves object manipulation targeting larger clinical effect and higher impact in terms of Activities of Daily Living ADL Further probing on the hypothesis that richer feedback may account for larger benefits the FES is complemented with a concurrently triggered active orthosis meant to smooth the grasping movement pattern and deliver more accurate proprioceptive feedback
Next to the main hypothesis of verifying the added value of the BCI component in terms of functional recovery but very importantly pre- post-intervention and follow-up assessments with several Transcranial Magnetic Stimulation TMS-based protocols and high-density EEG will serve so that this study takes a closer look on the intracortical and corticospinal tract plasticity mechanisms accompanying the therapy
The choice of studying a chronic stroke population is motivated by the ensemble of results acquired in previous BCI-based trials which suggest larger efficacy in this group
Objective The main objective of this study is to show that a combined FES and orthotic-assistance intervention leads to significantly better in the statistical sense functional improvement of the upper limb indexed with the Fugl-Meyer Assessment FMA scale for the upper limb FMA-UE when driven by an SMR-based BCI compared to a sham controller and that recovery can be lasting and clinically relevant
The hypothesized outcome upon study completion is a significant interaction between the within-subject factor time pre- and post-intervention and the between-subject factor Group BCI vs Sham when performing a mixed-design ANOVA on the studys primary outcome Additionally the BCI group is expected to yield significantly higher primary outcome values post-intervention compared to baseline with suitable post-hoc testing This difference should also exceed what is considered the clinically relevant threshold for chronic stroke samples The BCI group should ideally also be significantly higher in terms of primary outcome compared to the Sham group at the post-intervention and follow-up time points but not at baseline pre-intervention assessment It is a necessary prerequisite for confirming our hypothesis that at least the difference with respect to the primary outcome between post- and pre-intervention sessions is significantly larger in the BCI arm Deriving similar effects with respect to the defined secondary clinical outcomes especially those related to ADL is desirable
The secondary but of critical importance to the scientific question posed objective of this study is to demonstrate that greater functional recovery in the BCI group is associated with activity-dependent neural plasticity phenomena taking place or being profound only within this group The effects of the proposed therapy on motor cortex plasticity and Cortico-Spinal Tract CST excitability will be evaluated pre- and post-intervention as well as at follow-up The excitability of the primary motor cortex and of the corticospinal projections will be indexed with Motor Evoked Potential MEP amplitude and latency resting and active motor threshold RMT AMT after single-pulse TMS and with the intracortical inhibition and facilitation paradigm to paired-pulse TMS studied in the first dorsal interosseus FDI muscle or in more proximal muscles in case of lack of FDI-MEPs eg extensor carpi radialis ECR or flexor digitorum superficialis FDS
The synaptic plasticity of the motor cortex will be assessed through the modulation of MEP amplitude after the rapid paired associative stimulation rPAS protocol Changes in motor cortex plasticity and excitability are expected to follow the same trend as outlined above for the primary clinical outcome and additionally post-pre differences are anticipated to significantly correlate with the corresponding primary outcome differences for each individual participant both within each group and especially when pulling all subjects together It is also assumed that the same effects will be observed for EEG correlates eg functional connectivity within or across motor premotor and sensory areas of the two hemispheres event-related synchronizationdesynchronization ERDERS etc of motor attempt using pre- and post-intervention screening sessions as well as analyzing the EEG data of the therapeutic sessions
The possibility of Diffusion Tensor Imaging where patients perform similar reach-and-grasp movements inside the scanner to more profoundly study structural plasticity pre- and post-intervention will be pursued for eligible patients that agree to undergo this procedure
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