Clinical Validation of a Hybrid BCI-controlled FES for Upper Limb Rehabilitation After Stroke

NCT05511207 | Completed

• 2 other identifiers: GR-2018-12365874GR18.74
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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).

Conditions

Stroke Sequelae; Motor Disorders

Keywords

stroke; eeg; emg; cortico-muscular coherence; brain computer interface

Outcome Measures

Primary Outcomes (2)

• Changes in Fugl-Meyer Assessment (FMA) - upper limb section

  Commonly employed functional scale for post-stroke motor function. The scale ranges from 0 (maximum possible impairment) to 66 (no impairment).

  Pre-Randomization, Post Training (within 48 hours)

• Changes in Action Research Arm Test (ARAT)

  Commonly employed functional scale for post-stroke upper limb function. Consists of 19 items with a four scale point. Total scores on the ARAT may range from 0-57 points, with a maximum score of 57 points indicating better performance.

  Pre-Randomization, Post Training (within 48 hours)

Secondary Outcomes (5)

• Changes in Modified Ashworth Scale for Spasticity (MAS)

  Pre-Randomization, Post Training (within 48 hours)

• Changes Box and Block Test (BBT)

  Pre-Randomization, Post Training (within 48 hours)

• Changes Numeric Rating Scale for pain in the upper limb (NRS)

  Pre-Randomization, Post Training (within 48 hours)

• Changes in Manual Muscle Test (MMT) strength in upper limb segments

  Pre-Randomization, Post Training (within 48 hours)

• Changes in NIH Stroke Scale

  Pre-Randomization, Post Training (within 48 hours)

Other Outcomes (4)

• Changes in EEG activity and connectivity

  Pre-Randomization, Post Training (within 48 hours)

• Changes in EMG activation of target vs non target muscles.

  Pre-Randomization, Post Training (within 48 hours)

• Changes in CMC

  Pre-Randomization, Post Training (within 48 hours)

Study Arms (2)

RECOM - hBCI training

EXPERIMENTAL

Patients in the RECOM group will receive treatment in add-on to standard rehabilitation as follows. The RECOM device is a h-BCI system that controls FES of upper limb muscles: the patient is asked to attempt simple upper limb movements (eg extension of fingers); the device recognizes (in correct trials) close-to-normal EEG-EMG activation and initiates FES of extensor muscles in the forearm. RECOM training consists in a set of trial repetition for a total duration per session of approximately 20-30 minutes (excluding set up time and calibration). FES parameters will be set specifically for each patients according to standard guidelines to achieve full movement and so as to avoid any kind of discomfort for the patients. The intervention regimen will be 2-3 times per week for 4 consecutive weeks.

Device: RECOM - hBCI training

CTRL - upper limb training with FES

ACTIVE COMPARATOR

Patients in the CTRL group will receive treatment in add-on to standard rehabilitation as follows. An expert physiotherapist will define a set of active exercises focused on upper limb function; the exercises will be combined with FES of forearm muscles. FES parameters will be set specifically for each patients according to standard guidelines to achieve the full required movement and so as to avoid any kind of discomfort for the patients. Session duration will be approximately 20-30 minutes (excluding FES calibration time). The intervention regimen will be 2-3 times per week for 4 consecutive weeks.

Other: CTRL - upper limb training with FES

Interventions

RECOM - hBCI training DEVICE

The RECOM device is a h-BCI system that controls FES of upper limb muscles: the patient is asked to attempt simple upper limb movements (eg extension of fingers); the device recognizes (in correct trials) close-to-normal EEG-EMG activation and initiates FES of extensor muscles in the forearm. RECOM training consists in a set of trial repetition for a total duration per session of approximately 20-30 minutes (excluding set up time and calibration). FES parameters will be set specifically for each patients according to standard guidelines to achieve full movement and so as to avoid any kind of discomfort for the patients. The intervention regimen will be 2-3 times per week for 4 consecutive weeks.

RECOM - hBCI training

CTRL - upper limb training with FES OTHER

An expert physiotherapist will define a set of active exercises focused on upper limb function; the exercises will be combined with FES of forearm muscles. FES parameters will be set specifically for each patients according to standard guidelines to achieve the full required movement and so as to avoid any kind of discomfort for the patients. Session duration will be approximately 20-30 minutes (excluding FES calibration time). The intervention regimen will be 2-3 times per week for 4 consecutive weeks.

CTRL - upper limb training with FES

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• unilateral stroke event at least 3 months before recruitment
• reduced strength in the upper limb

You may not qualify if:

• concomitant diseases affecting upper limb function
• spasticity in the upper limb (4-5 of MAS)
• severe neuropsychological deficit preventing active participation to the study
• contraindication to FES or EEG/EMG recording

Sponsors & Collaborators

• Donatella Mattia: lead
• University of Roma La Sapienza: collaborator

Study Sites (1)

Neurorehabilitation Units- Fondazione Santa Lucia, IRCCS

Rome, Italy, 00179, Italy

Location

Related Publications (7)

• Pichiorri F, Morone G, Petti M, Toppi J, Pisotta I, Molinari M, Paolucci S, Inghilleri M, Astolfi L, Cincotti F, Mattia D. Brain-computer interface boosts motor imagery practice during stroke recovery. Ann Neurol. 2015 May;77(5):851-65. doi: 10.1002/ana.24390. Epub 2015 Mar 27.

  PMID: 25712802 BACKGROUND

• Peng Y, Wang J, Liu Z, Zhong L, Wen X, Wang P, Gong X, Liu H. The Application of Brain-Computer Interface in Upper Limb Dysfunction After Stroke: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Front Hum Neurosci. 2022 Mar 29;16:798883. doi: 10.3389/fnhum.2022.798883. eCollection 2022.

  PMID: 35422693 BACKGROUND

• Colamarino E, de Seta V, Masciullo M, Cincotti F, Mattia D, Pichiorri F, Toppi J. Corticomuscular and Intermuscular Coupling in Simple Hand Movements to Enable a Hybrid Brain-Computer Interface. Int J Neural Syst. 2021 Nov;31(11):2150052. doi: 10.1142/S0129065721500520. Epub 2021 Sep 30.

  PMID: 34590990 BACKGROUND

• Chen YT, Li S, Magat E, Zhou P, Li S. Motor Overflow and Spasticity in Chronic Stroke Share a Common Pathophysiological Process: Analysis of Within-Limb and Between-Limb EMG-EMG Coherence. Front Neurol. 2018 Oct 9;9:795. doi: 10.3389/fneur.2018.00795. eCollection 2018.

  PMID: 30356703 BACKGROUND

• Silva CC, Silva A, Sousa A, Pinheiro AR, Bourlinova C, Silva A, Salazar A, Borges C, Crasto C, Correia MV, Vilas-Boas JP, Santos R. Co-activation of upper limb muscles during reaching in post-stroke subjects: an analysis of the contralesional and ipsilesional limbs. J Electromyogr Kinesiol. 2014 Oct;24(5):731-8. doi: 10.1016/j.jelekin.2014.04.011. Epub 2014 May 9.

  PMID: 24882699 BACKGROUND

• von Carlowitz-Ghori K, Bayraktaroglu Z, Hohlefeld FU, Losch F, Curio G, Nikulin VV. Corticomuscular coherence in acute and chronic stroke. Clin Neurophysiol. 2014 Jun;125(6):1182-91. doi: 10.1016/j.clinph.2013.11.006. Epub 2013 Nov 16.

  PMID: 24315544 BACKGROUND

• Pichiorri F, Mattia D. Brain-computer interfaces in neurologic rehabilitation practice. Handb Clin Neurol. 2020;168:101-116. doi: 10.1016/B978-0-444-63934-9.00009-3.

  PMID: 32164846 BACKGROUND

Related Links

• Description of available Hybrid BCI prototype
• Adaptation of Hybrid BCI prototype

MeSH Terms

Conditions

Motor Disorders; Stroke

Interventions

proto-oncogene protein c-fes-fps

Condition Hierarchy (Ancestors)

Mental Disorders; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Floriana Pichiorri, MD, PhD

  Fondazione Santa Lucia, IRCCS

  PRINCIPAL INVESTIGATOR

• Jlenia Toppi, Prof

  University of Roma La Sapienza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Clinical/Functional evaluation of patients will be performed by expert physiotherapists blinded to group allocation. Data analysis (EEG, EMG, cinematic) will be performed by neuroscientists blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Laboratory Director

Model Details: Eligible patients admitted to Fondazione Santa Lucia will be randomized in equal proportions between target intervention (RECOM) and control (CTRL)

Study Record Dates

• First Submitted: August 12, 2022
• First Posted: August 22, 2022
• Study Start: March 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 17, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)