Stroke Clinical Trial
— BCI-FESOfficial title:
Application of Functional Electrical Stimulation Therapy Coupled to a P300-based Brain-Computer Interface for Paretic Upper Limb Rehabilitation in Chronic Stroke: A Randomized Controlled Trial
NCT number | NCT06409754 |
Other study ID # | 24-2024 |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2024 |
Est. completion date | August 2025 |
The objective of this research is to evaluate the benefits 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 and occupational therapy, while the second one will receive conventional therapy together with BCI-FES therapy. The control and experimental group will receive 20 sessions of conventional physical and occupational therapy at a rate of five sessions per week for 4 weeks (control group double dose of conventional therapy), 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. To evaluate the results, a series of tests will be applied to assess the motor recovery, 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. Likewise, resting state functional magnetic resonance imaging studies will be performed to evaluate the degree of functional connectivity between various brain regions of interest related to the planning and execution of movements. This will determine whether the experimental therapy with BCI-FES favors arm and hand recovery in surviving stroke individuals.
Status | Not yet recruiting |
Enrollment | 33 |
Est. completion date | August 2025 |
Est. primary completion date | February 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - Neurological disorders (Parkinson's 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 fMRI (implantable devices -pacemakers-, claustrophobia) - Cognitive deficit (MoCA test < 26 points) - Severe aphasia - Psychiatric disorders - More than one stroke |
Country | Name | City | State |
---|---|---|---|
Mexico | Instituto Nacional de Rehabilitación Luis Guillermo Ibarra Ibarra | México City | Cdmx |
Lead Sponsor | Collaborator |
---|---|
Instituto Nacional de Rehabilitacion |
Mexico,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
undefined
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. — View Citation
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. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Upper limb function | Action Research Arm Test (ARAT), Minimum Value: 0 - Maximum Value: 57, Higher Score = Better Outcome. | It will be assessed at baseline before beginning the intervention, and after the end of intervention (4 weeks later). | |
Secondary | Upper limb spasticity | Modified Ashworth Scale (MAS), Minimum Value: 0 - Maximum Value: 4, Higher Score = Worse Outcome. | It will be assessed at baseline before beginning the intervention, and after the end of intervention (4 weeks later). | |
Secondary | Upper limb functional independence | Functional Independence Measure (FIM), Minimum Value: 18 - Maximum Value: 126, Higher Score = Better Outcome. | It will be assessed at baseline before beginning the intervention, and after the end of intervention (4 weeks later). | |
Secondary | Upper limb functional independence. | Motor Activity Log (MAL-30), Minimum Value: 0 - Maximum Value: 150, Higher Score = Better Outcome. | It will be assessed at baseline before beginning the intervention, and after the end of intervention (4 weeks later). | |
Secondary | Functional Connectivity of the brain motor regions of interest | Measured through resting-state fMRI | It will be assessed at baseline before beginning the intervention, and after the end of intervention (4 weeks later). |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Recruiting |
NCT03869138 -
Alternative Therapies for Improving Physical Function in Individuals With Stroke
|
N/A | |
Completed |
NCT04101695 -
Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects
|
N/A | |
Completed |
NCT04034069 -
Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial
|
N/A | |
Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
Completed |
NCT00391378 -
Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS)
|
N/A | |
Recruiting |
NCT06204744 -
Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial
|
N/A | |
Active, not recruiting |
NCT06043167 -
Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
|
||
Active, not recruiting |
NCT04535479 -
Dry Needling for Spasticity in Stroke
|
N/A | |
Completed |
NCT03985761 -
Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke
|
N/A | |
Recruiting |
NCT00859885 -
International PFO Consortium
|
N/A | |
Recruiting |
NCT06034119 -
Effects of Voluntary Adjustments During Walking in Participants Post-stroke
|
N/A | |
Completed |
NCT03622411 -
Tablet-based Aphasia Therapy in the Chronic Phase
|
N/A | |
Completed |
NCT01662960 -
Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke
|
N/A | |
Recruiting |
NCT05854485 -
Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke
|
N/A | |
Active, not recruiting |
NCT05520528 -
Impact of Group Participation on Adults With Aphasia
|
N/A | |
Completed |
NCT03366129 -
Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
|
||
Completed |
NCT03281590 -
Stroke and Cerebrovascular Diseases Registry
|
||
Completed |
NCT05805748 -
Serious Game Therapy in Neglect Patients
|
N/A | |
Recruiting |
NCT05621980 -
Finger Movement Training After Stroke
|
N/A |