BCI-FES for Upper Limb Rehabilitation in Chronic Stroke

NCT06409754 | Recruiting

• 1 other identifier: 24-2024
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this research is to evaluate the efficacy of an experimental therapy for motor recovery of the arm after a stroke, which includes the application of a functional electrical stimulation therapy coupled to P-300 based Brain-Computer Interface system (BCI-FES). For this purpose, the investigators will compare two groups, the first one will receive only conventional physical therapy, while the second one will receive physical conventional therapy together with BCI-FES therapy. The control and experimental group will receive 20 sessions of conventional physical therapy at a rate of five sessions per week for 4 weeks, and the experimental group will receive 20 sessions of rehabilitation with the BCI-FES system at a rate of five sessions per week for 4 weeks. Broadly speaking, the BCI is in charge of determining the movement selected by the individual and assist the hand movement while performing functional tasks. The movements included in the sessions will be hand opening, grasping, pinching, pronation and supination, which are combined to facilitate the execution of functional movements that are performed together with the manipulation of daily used utensils. The visual, sensory and motor feedback provided by the BCI-FES system that enables the individual to replicate the afferent-efferent motor circuit, contributes to the activation and recruitment of neural pathways, which is associated with motor recovery. It should be noted that this BCI-FES system has already been tested previously in a study with healthy individuals, and in a non-randomized pilot study that used this therapy for upper limb motor function recovery in chronic post-stroke patients. It showed positive results, and the therapy was safe and tolerated by all the patients. Besides no adverse event related to the intervention occurred. To evaluate the results, a series of tests will be applied to assess the motor recovery and level of independence, including the FMA-UE: Fugl-Meyer Assessment Scale of Upper Extremity, ARAT: Action Research Arm Test, MAS: Modified Ashworth Scale, FIM: Functional Independence Measure and MAL: Motor Activity Log. Moreover, to assess neuroplasticity, two neuroimaging techniques including magnetic resonance imaging and electroencephalography will be used.

Conditions

Stroke; Upper Extremity Paresis; Neuronal Plasticity

Keywords

Stroke; Upper Extremity Paresis; Neurorehabilitation; Brain-Computer Interfaces; Functional Electrical Stimulation; Neuronal Plasticity; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• Upper limb motor recovery

  Fugl-Meyer Assessment Scale of Upper Extremity (FMA-UE), Minimum Value: 0 - Maximum Value: 66, Higher Score = Better Outcome.

  It will be assessed at baseline before beginning the intervention, and after the end of intervention (4 weeks later).

Secondary Outcomes (6)

• Upper limb function

  It will be assessed at baseline before beginning the intervention, and after the end of intervention (4 weeks later).

• Upper limb spasticity

  It will be assessed at baseline before beginning the intervention, and after the end of intervention (4 weeks later).

• Upper limb functional independence

  It will be assessed at baseline before beginning the intervention, and after the end of intervention (4 weeks later).

• Upper limb functional independence.

  It will be assessed at baseline before beginning the intervention, and after the end of intervention (4 weeks later).

• Structural Anatomy, Structural Connectivity and Functional Connectivity

  It will be assessed at baseline before beginning the intervention, and after the end of intervention (4 weeks later).

Study Arms (2)

Experimental Group

EXPERIMENTAL

The experimental group will receive both Functional Electrical Stimulation therapy coupled to the P300-based Brain-Computer Interface system and conventional physical therapy.

Device: Functional Electrical Stimulation Therapy coupled to a P-300 based Brain-Computer Interface; Other: Conventional Physical Therapy

Control Group

ACTIVE COMPARATOR

The control group will receive double conventional physical therapy to equalize the time dosages received by the experimental group.

Other: Conventional Physical Therapy

Interventions

Functional Electrical Stimulation Therapy coupled to a P-300 based Brain-Computer Interface DEVICE

The intervention involves a BCI control strategy based on a modified version of the classic P300 Donchin Speller Interface, where the matrix of letters and symbols is replaced by a set of pictures including five hand gestures and wrist orientations: hand opening, grasping, pinching, pronation, and supination. This BCI approach is based on the oddball paradigm, relying on conscious recognition by the user of the intensification of a particular target movement picture, within a sequence of other, non-target, random visual stimuli. This process should evoke the P300 component in the event related potential. The aim of the training sessions is to link an action observation/target selection task, mediated by the P300-based BCI, with the practice of a FES-assisted functional task involving the target movement picture selected. Users will be instructed to synchronize their voluntary movements with the ones induced by FES, to achieve the functional target goal.

Experimental Group

Conventional Physical Therapy OTHER

Conventional physical and occupational therapy will include sessions of joint mobility, muscle strength, task-specific training, sensitivity reeducation and coordination exercises directed by an experienced professional therapist.

Control Group; Experimental Group

Eligibility Criteria

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

You may qualify if:

• Patients with ischemic or hemorrhagic stroke (evidenced by CT or MRI)
• ≥6 months from stroke onset, chronic phase
• Unilateral lesion
• Age ≥18 years
• Moderate-severe hemiparesis (FMA-UE: ≤45)
• Full passive ranges of motion in the elbow, forearm, wrist, and hand
• Minimal cognitive level necessary to follow instructions and complete tasks
• Desire to participate in the study

You may not qualify if:

• Neurological disorders (Parkinsons disease, epilepsy, dementia)
• Neurological or musculoskeletal condition directly affecting the upper limb (dystonia, severe spasticity -muscle tone for elbow, wrist and fingers \> 3 according to modified Ashworth scale-)
• Contraindications for MRI (implantable devices -pacemakers-, claustrophobia, others)
• Cognitive deficit (MoCA \<20 points)
• Severe aphasia
• Severe psychiatric disorders
• More than one stroke

Sponsors & Collaborators

• Instituto Nacional de Rehabilitacion: lead

Study Sites (1)

Instituto Nacional de Rehabilitación Luis Guillermo Ibarra Ibarra

Mexico City, Mexico City, 14389, Mexico

RECRUITING

Related Publications (14)

• Sanders ZB, Fleming MK, Smejka T, Marzolla MC, Zich C, Rieger SW, Luhrs M, Goebel R, Sampaio-Baptista C, Johansen-Berg H. Self-modulation of motor cortex activity after stroke: a randomized controlled trial. Brain. 2022 Oct 21;145(10):3391-3404. doi: 10.1093/brain/awac239.

  PMID: 35960166 BACKGROUND

• Hawkinson JE, Ross AJ, Parthasarathy S, Scott DJ, Laramee EA, Posecion LJ, Rekshan WR, Sheau KE, Njaka ND, Bayley PJ, deCharms RC. Quantification of adverse events associated with functional MRI scanning and with real-time fMRI-based training. Int J Behav Med. 2012 Sep;19(3):372-81. doi: 10.1007/s12529-011-9165-6.

  PMID: 21633905 BACKGROUND

• Qu H, Zeng F, Tang Y, Shi B, Wang Z, Chen X, Wang J. The clinical effects of brain-computer interface with robot on upper-limb function for post-stroke rehabilitation: a meta-analysis and systematic review. Disabil Rehabil Assist Technol. 2024 Jan;19(1):30-41. doi: 10.1080/17483107.2022.2060354. Epub 2022 Apr 21.

  PMID: 35450498 BACKGROUND

• Xie YL, Yang YX, Jiang H, Duan XY, Gu LJ, Qing W, Zhang B, Wang YX. Brain-machine interface-based training for improving upper extremity function after stroke: A meta-analysis of randomized controlled trials. Front Neurosci. 2022 Aug 3;16:949575. doi: 10.3389/fnins.2022.949575. eCollection 2022.

  PMID: 35992923 BACKGROUND

• Ramos-Murguialday A, Broetz D, Rea M, Laer L, Yilmaz O, Brasil FL, Liberati G, Curado MR, Garcia-Cossio E, Vyziotis A, Cho W, Agostini M, Soares E, Soekadar S, Caria A, Cohen LG, Birbaumer N. Brain-machine interface in chronic stroke rehabilitation: a controlled study. Ann Neurol. 2013 Jul;74(1):100-8. doi: 10.1002/ana.23879. Epub 2013 Aug 7.

  PMID: 23494615 BACKGROUND

• Kalra J, Mittal P, Mittal N, Arora A, Tewari U, Chharia A, Upadhyay R, Kumar V, Longo L. How Visual Stimuli Evoked P300 is Transforming the Brain-Computer Interface Landscape: A PRISMA Compliant Systematic Review. IEEE Trans Neural Syst Rehabil Eng. 2023;31:1429-1439. doi: 10.1109/TNSRE.2023.3246588.

  PMID: 37027569 BACKGROUND

• Allison BZ, Kubler A, Jin J. 30+ years of P300 brain-computer interfaces. Psychophysiology. 2020 Jul;57(7):e13569. doi: 10.1111/psyp.13569. Epub 2020 Apr 17.

  PMID: 32301143 BACKGROUND

• Lebedev MA, Nicolelis MA. Brain-Machine Interfaces: From Basic Science to Neuroprostheses and Neurorehabilitation. Physiol Rev. 2017 Apr;97(2):767-837. doi: 10.1152/physrev.00027.2016.

  PMID: 28275048 BACKGROUND

• Yang S, Li R, Li H, Xu K, Shi Y, Wang Q, Yang T, Sun X. Exploring the Use of Brain-Computer Interfaces in Stroke Neurorehabilitation. Biomed Res Int. 2021 Jun 18;2021:9967348. doi: 10.1155/2021/9967348. eCollection 2021.

  PMID: 34239936 BACKGROUND

• Leeb R, Perez-Marcos D. Brain-computer interfaces and virtual reality for neurorehabilitation. Handb Clin Neurol. 2020;168:183-197. doi: 10.1016/B978-0-444-63934-9.00014-7.

  PMID: 32164852 BACKGROUND

• Katan M, Luft A. Global Burden of Stroke. Semin Neurol. 2018 Apr;38(2):208-211. doi: 10.1055/s-0038-1649503. Epub 2018 May 23.

  PMID: 29791947 BACKGROUND

• undefined

  BACKGROUND

• Camacho-Zavala JK, Perez-Medina AL, Mercado-Gutierrez JA, Gutierrez MI, Gutierrez-Martinez J, Aguirre-Guemez AV, Quinzanos-Fresnedo J, Perez-Orive J. Personalized protocol and scoring scale for functional electrical stimulation of the hand: A pilot feasibility study. Technol Health Care. 2022;30(1):51-63. doi: 10.3233/THC-213016.

  PMID: 34397438 BACKGROUND

• Ramirez-Nava AG, Mercado-Gutierrez JA, Quinzanos-Fresnedo J, Toledo-Peral C, Vega-Martinez G, Gutierrez MI, Pacheco-Gallegos MDR, Hernandez-Arenas C, Gutierrez-Martinez J. Functional electrical stimulation therapy controlled by a P300-based brain-computer interface, as a therapeutic alternative for upper limb motor function recovery in chronic post-stroke patients. A non-randomized pilot study. Front Neurol. 2023 Aug 17;14:1221160. doi: 10.3389/fneur.2023.1221160. eCollection 2023.

  PMID: 37669261 BACKGROUND

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

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

Study Officials

• Josefina Gutiérrez Martínez, Eng/PhD

  Instituto Nacional de Rehabilitación

  STUDY CHAIR

Central Study Contacts

Jimena Quinzaños Fresnedo, MD, PhD

CONTACT

+52 5559991000; jquinzanos@inr.gob.mx

Gabriel Manrique Gutiérrez, MD/PhDc

CONTACT

+52 4772842455; gabriel.manrique.gtz@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Head of the Neurological Rehabilitation Department

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 10, 2024
• Study Start: August 6, 2024
• Primary Completion: July 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)