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,
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* 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). |
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