BCI-assisted MI Intervention in Subacute Stroke

NCT ID: NCT04353297

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-28
• Study Completion Date: 2023-12-01

Brief Summary

Stroke is a leading cause of long-term disability. Cost-effective post-stroke rehabilitation programs are critically needed. Brain-Computer Interface (BCI) systems which enable the modulation of EEG sensorimotor rhythms are promising tools to promote early improvements of motor rehabilitation outcomes after stroke. This project intends to boost this BCI application beyond the state of art by providing: i) evidence for a short/long-term efficacy in enhancing post-stroke functional hand motor recovery; and ii) quantifiable indices (beyond clinical scales) sensitive to stroke participant's response to a Promotoer (BCI system compatible with clinical setting) -based intervention. To these aims, a longitudinal randomized controlled trial will be performed in which, subacute stroke participants will undergo a Promotoer- assisted hand motor imagery training.

Detailed Description

Stroke is a major public health and social care concern worldwide, being the leading cause of long-term disability in adults. The upper limb motor impairment commonly persists after stroke affecting patients' everyday life functional independence. Despite the intensive rehabilitation, the variability in the nature and the extent of upper limb recovery remains a crucial factor effecting rehabilitation outcomes. Electroencephalography (EEG) -based Brain Computer Interface (BCI) technology is a potential tool to promote functional motor recovery of upper limbs after stroke as shown in several randomized controlled trials. The investigators' multidisciplinary team was successful in designing, implementing and clinically validating a sensorimotor rhythm-based BCI combined with realistic visual feedback of upper limb to support hand motor imagery (MI) practice in stroke participants. However, important questions remain to be addressed to translate BCI in clinical practice such as defining whether the expected BCI-induced early improvements in functional motor outcomes can be sustained in a long-term after stroke. This requires advancements in the knowledge on brain functional re-organization after stroke and how this re-organization would correlate with the functional motor outcome (evidence-base medicine). Last but not least, the definition of the determinants of the patient response to-treatment is paramount to optimize the process of personalized medicine in rehabilitation. The fundamental of this project stems from the investigators' previous findings on the efficacy of BCI-assisted MI training in subacute stroke participants. These promising findings corroborated the idea that a relatively low-cost technique (i.e. EEG-based BCI) can be exploited to deliver a rehabilitative intervention (in this case MI) and prompted the research team to undertake a further translational effort by implementing an all-in-one BCI-supported MI training station- the Promotoer. In this project, the investigators will provide evidence for a persistency (up to 6 months) of the significant early improvement of hand motor function induced by the BCI-assisted MI training operated via the Promotoer. Task-specific training was recently reported to induce long-term improvements (6 months follow-up) in arm motor function after stroke. Thus, the hypothesis is that the BCI-based rewarding of hand MI tasks would promote long-lasting retention of early induced positive effect on motor performance with respect to MI task practiced in an open loop condition (i.e., without BCI). Further hypothesis is that such clinical improvement would be sustained by a long-lasting neuroplasticity changes that would be harnessed by the BCI -based intervention. This hypothesis rises from current evidence for an early enhancement of post-stroke plastic changes enabled by BCI- based trainings. To test this hypothesis, a longitudinal assessment of the brain network organization derived from advanced EEG signal processing will be performed. The heterogeneity of stroke makes prediction of treatment responder a great challenge. The investigators hypothesize that the longitudinal functional and neurophysiology assessment over 6 months from the intervention will allow for insights in biomarkers and potential predictors of stroke participants' response to the Promotoer training. Some of the well-recognized factors contributing to functional motor recovery after stroke such as the relation between lesion characteristics and patterns of post-stroke motor cortical re-organization (e.g., ipsilesional/contralesional primary and non-primary motor areas; cortico-spinal tract integrity, severity of motor deficits at baseline) will be taken into account.

Conditions

Stroke; Motor Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

BCI Group

(EEG-)BCI- assisted MI training delivered as add-on regimen (Standard physiotherapy-3 h/day, 5 day/week).

Group Type: EXPERIMENTAL

EEG-based BCI system for (hand) Motor Imagery training

Intervention Type: OTHER

The Promotoer is an all-in-one BCI-supported motor imagery (MI) training station, equipped with a computer, a commercial wireless Electroencephalography (EEG)/ Electromyography (EMG) system, a screen for therapist feedback (EEG and EMG activity monitoring) and screen for the real-time ecological feedback to patient - a custom software program that provides a for (personalized) visual representation of the patient's own hands. As such, this software allows the therapists to create an artificial reproduction of a given patient's hand/forearm by adjusting a digitally created image in shape, size, skin colour and orientation to match as much as possible the real patient hand/forearm. Training consists of the MI tasks only of the affected hand, grasping or finger extension in separate runs. The trial length will include a constant baseline period of 4 sec and a task period of maximally 10 sec for BCI intervention group. Each training session will consist of 4 runs (20 trials each).

Control Group

MI training without BCI support delivered as add-on regimen (Standard physiotherapy-3 h/day, 5 day/week).

Group Type: ACTIVE_COMPARATOR

Motor Imagery training

Intervention Type: OTHER

Training consists of MI tasks only of the affected hand, grasping or finger extension in separate runs. MI training will be delivered without BCI support (ie., the Promotoer system will not provide real-time feedback of MI performance; hand/forearm visual representation will remain standstill) with a dose/setting regimen equivalent to EXP intervention. The trial length will include a constant baseline period of 4 sec and a task period of maximally 4 sec. Each training session will consist of 4 runs (20 trials each).

Interventions

EEG-based BCI system for (hand) Motor Imagery training

The Promotoer is an all-in-one BCI-supported motor imagery (MI) training station, equipped with a computer, a commercial wireless Electroencephalography (EEG)/ Electromyography (EMG) system, a screen for therapist feedback (EEG and EMG activity monitoring) and screen for the real-time ecological feedback to patient - a custom software program that provides a for (personalized) visual representation of the patient's own hands. As such, this software allows the therapists to create an artificial reproduction of a given patient's hand/forearm by adjusting a digitally created image in shape, size, skin colour and orientation to match as much as possible the real patient hand/forearm. Training consists of the MI tasks only of the affected hand, grasping or finger extension in separate runs. The trial length will include a constant baseline period of 4 sec and a task period of maximally 10 sec for BCI intervention group. Each training session will consist of 4 runs (20 trials each).

Intervention Type: OTHER

Motor Imagery training

Training consists of MI tasks only of the affected hand, grasping or finger extension in separate runs. MI training will be delivered without BCI support (ie., the Promotoer system will not provide real-time feedback of MI performance; hand/forearm visual representation will remain standstill) with a dose/setting regimen equivalent to EXP intervention. The trial length will include a constant baseline period of 4 sec and a task period of maximally 4 sec. Each training session will consist of 4 runs (20 trials each).

Intervention Type: OTHER

Other Intervention Names

BCI- MI Intervention; Control- MI Intervention

Eligibility Criteria

Inclusion Criteria

• first ever unilateral stroke - confirmed by MRI;
• hemiplegia/hemiparesis from 1 to 6 months since stroke;
• age between 18 and 80 years;

Exclusion Criteria

• severe neglect and aphasia;
• dementia;
• severe spasticity - Modified Ashworth Scale >4 at shoulder/elbow/wrist;
• Upper Extremity Fugl-Meyer Assessment (UE-FMA) >47/60 score (60 is without considering 6 score point for tendon reflexes);
• Token test >29 score;
• concomitant neurological disorders

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: collaborator

Istituto Superiore di Sanità

OTHER

Sponsor Role: collaborator

I.R.C.C.S. Fondazione Santa Lucia

OTHER

Sponsor Role: lead

Responsible Party

Donatella Mattia

Professor, laboratory director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Donatella Mattia, MD,PhD

Role: STUDY_CHAIR

Fondazione Santa Lucia, IRCCS

Marco Molinari, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Santa Lucia, IRCCS

Locations

Neurorehabilitation Units- Fondazione Santa Lucia, IRCCS

Rome, , Italy

Countries

Italy

References

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Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: DERIVED

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Other Identifiers

RF-2018-12365210

Identifier Type: -

Identifier Source: org_study_id