BCI Driving FES and Hand Orthosis for Upper Limb Rehabilitation in Chronic Stroke

NCT06179745 | Unknown

• 1 other identifier: BCIFESOrthosis
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Cerebrovascular; Hemiplegia and Hemiparesis; Stroke/Brain Attack

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Assessment - Upper Extremity (FMA-UE)

  Fugl-Meyer Assessment (FMA), upper limb department (FMA-UE) including reflexes (0-66 scale). The higher the FMA-UE outcome, the less the disability of the upper limb.

  Pre-intervention (1-2 days before intervention onset), immediately post-intervention and 6-month follow-up (at least 6 months after the end of the intervention)

Secondary Outcomes (2)

• Medical Research Council (MRC) muscle strength

  Pre-intervention (1-2 days before intervention onset), immediately post-intervention and 6-month follow-up (at least 6 months after the end of the intervention)

• Self-efficacy of daily living

  Pre-intervention (1-2 days before intervention onset), immediately post-intervention and 6-month follow-up (at least 6 months after the end of the intervention)

Study Arms (2)

Brain-computer interface (BCI)

EXPERIMENTAL

In the BCI arm, FES stimulation and orthosis triggering are only initiated when the BCI infers "on line" (in real time) the presence of adequate SMRs or ERD/ERS within the epoch. That is, there is precise contingency between the efferent motor command and the afferent feedback induced by BCI-driven actuators (the patient feels he/she can move his upper limb when he wants to do it).

Combination Product: EEG-based brain-computer interface; Device: Functional Electrical Stimulation; Device: Active hand orthosis

Sham-Brain-computer interface (Sham-BCI)

SHAM COMPARATOR

In the Sham-BCI group, any EEG signals encoding motor intention of the patient are ignored. FES/orthosis triggering is decided at random, by "playing back" the data of a randomly selected run of a previously recruited participant. Hence, in the Sham-BCI arm, there is no guaranteed contingency between the efferent motor command and the afferent feedback induced by the FES and the orthosis, although it can still happen by coincidence.

Combination Product: Sham EEG-based brain-computer interface; Device: Functional Electrical Stimulation; Device: Active hand orthosis

Interventions

EEG-based brain-computer interface COMBINATION_PRODUCT

EEG-based brain-computer interface detecting the patient's EEG sensorimotor rhythms associated to attempted reach-gasp-release upper limb movements by the patient.

Brain-computer interface (BCI)

Sham EEG-based brain-computer interface COMBINATION_PRODUCT

Fake (Sham) EEG-based brain-computer interface which outputs a decision at random about whether EEG sensorimotor rhythms associated to attempted reach-gasp-release upper limb movements by the patient are currently detected.

Sham-Brain-computer interface (Sham-BCI)

Functional Electrical Stimulation DEVICE

Neuromuscular stimulation of several upper limb muscles (elbow extensors, hand extensors/flexors) to effectuate reach, grasp and release movements of the affected upper limb.

Brain-computer interface (BCI); Sham-Brain-computer interface (Sham-BCI)

Active hand orthosis DEVICE

Active hand orthosis effectuating reach, grasp and release movements of the affected uppe r limb.

Brain-computer interface (BCI); Sham-Brain-computer interface (Sham-BCI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• More than 18 years of age
• Victim of ischemic or haemorrhagic cerebrovascular accident (CVA)
• At least 6 months since occurrence of CVA. No upper limit on time since stroke is imposed
• First CVA

You may not qualify if:

• Unilateral cortical lesions (left or right hemisphere), subcortical lesions or supra-pontic lesions of the corticospinal tract having caused paralysis of the upper limb as documented by radiologic evidence
• Adequate or corrected vision
• Any reason obstructing EEG acquisition (scalp infections or wounds, dermatitis, etc)
• Severe concomitant diseases (fever, infections, cardiac conditions, etc)
• Heavy medication affecting the central nervous system (CNS, especially vigilance)
• CVA with multiple infarcts
• Second or later CVA
• Severe unilateral hemispatial neglect as assessed by the behavioural part of the Behavioural Inattention Test (BIT) and the Fluff Test for body neglect
• Severe cognitive disability affecting speech production, communication (e.g. aphasia), the ability to understand and give clear and free informed consent and to fully understand and comply with protocol instructions. A score of above 22/30 of the Montreal Cognitive Assessment (MoCA) scale is advised Inability to concentrate for 2 consecutive hours
• Concomitant neurological conditions (e.g. Parkinson's disease) Severe spasticity. The Modified Ashworth Scale (MAS) score at the elbow, wrist and fingers should be below or equal to 2.
• Severe dystonia, dyskinesia or pain
• Cardiac pacemaker, active implants and other contraindications for FES
• Metallic implants affecting EEG acquisition
• Patients for whom it is not possible to evoke a MEP greater than or equal to 0.2 mV amplitude at rest from the FDI and more proximal muscles (like ECR, FDS, etc) of the affected limb, or with contraindications for the TMS or Diffusion Tensor Imaging (DTI) protocols, will not undergo the respective procedures but will not be excluded from the trial.

Sponsors & Collaborators

• University of Essex: lead
• Azienda Sanitaria dell'Alto Adige: collaborator
• Landeskrankenhaus Hochzirl: collaborator

Study Sites (1)

Ospedale di Vipiteno | Azienda Sanitaria dell'Alto Adige

Sterzing, Trentino-Alto Adige, 39049, Italy

RECRUITING

Related Publications (2)

• Cervera MA, Soekadar SR, Ushiba J, Millan JDR, Liu M, Birbaumer N, Garipelli G. Brain-computer interfaces for post-stroke motor rehabilitation: a meta-analysis. Ann Clin Transl Neurol. 2018 Mar 25;5(5):651-663. doi: 10.1002/acn3.544. eCollection 2018 May.

  PMID: 29761128 BACKGROUND

• Biasiucci A, Leeb R, Iturrate I, Perdikis S, Al-Khodairy A, Corbet T, Schnider A, Schmidlin T, Zhang H, Bassolino M, Viceic D, Vuadens P, Guggisberg AG, Millan JDR. Brain-actuated functional electrical stimulation elicits lasting arm motor recovery after stroke. Nat Commun. 2018 Jun 20;9(1):2421. doi: 10.1038/s41467-018-04673-z.

  PMID: 29925890 BACKGROUND

MeSH Terms

Conditions

Stroke; Hemiplegia; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Serafeim Perdikis, PhD

CONTACT

00447394404046; serafeim.perdikis@essex.ac.uk

Viviana Versace, PhD, MD

CONTACT

0039472774580; viviana.versace@sabes.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants in both groups (BCI, Sham) are fitted with the exact same equipment (EEG cap, FES device, assistive hand orthosis). In the BCI group, FES stimulation and orthosis triggering are only initiated when the BCI infers "on line" the presence of adequate SMRs or ERD/ERS within the epoch. That is, there is precise contingency between the efferent motor command and the afferent feedback induced by BCI-driven actuators (the patient feels he/she can move his upper limb when he wants to do it). Conversely, in the sham group, the any EEG signals of motor intention will be ignored and FES/orthosis triggering is decided at random. Each closed-loop BCI sub-movement epoch operates with a timeout of 2 seconds. In case the BCI detects no adequate SMR EEG correlates within this interval, the auditory cue commands an additional movement attempt and the epoch will be repeated as many times as needed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Allocation to the two experimental groups (BCI and Sham) will be taking place at the University of Essex, so as to ensure therapists in the recruitment center remain blind to this information. A toolbox implementing Frane's minimization algorithm (Frane 1998), built by the University of Essex partners will be employed. Use of a covariate adaptive randomization algorithm is dictated by several reasons. First, patients will be recruited on the fly and the studied sample will not be known at trial onset, so that an adaptive allocation method is needed and stratified randomization methods are excluded. The identified possible confounding factors that will be balanced are: Group (BCI vs Sham), Age (in years), Gender, Time since CVA (in months), Primary outcome at pre-intervention screening time point, Lesion type (haemorrhagic vs ischemic), Lesion location (cortical vs subcortical), Lesion side (left vs right), Pre-treatment of spasticity (yes or no).

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 22, 2023
• Study Start: March 14, 2022
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: December 22, 2023

Record last verified: 2023-12

Locations

IT (1)