BCI-FES for Upper Limb Rehabilitation in Chronic Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstituto Nacional de Rehabilitacion
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with ischemic or hemorrhagic stroke (evidenced by CT or MRI)
≥6 months from stroke onset, chronic phase
Unilateral lesion
Age ≥18 years
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Functional Electrical Stimulation Therapy coupled to a P-300 based Brain-Computer Interface
DeviceThe 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.
Conventional Physical Therapy
Other interventionConventional 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.
Treatment groups
26 Participants
are divided into 2 treatment groupsGroup A: Experimental GroupExperimental treatment 2 interventions
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
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.
Time frame
It will be assessed at baseline before beginning the intervention, and after the end of intervention (4 weeks later).Secondary outcomes
1
Upper limb function
Action Research Arm Test (ARAT), Minimum Value: 0 - Maximum Value: 57, Higher Score = Better Outcome.
Time frame
It will be assessed at baseline before beginning the intervention, and after the end of intervention (4 weeks later).2
Upper limb spasticity
Modified Ashworth Scale (MAS), Minimum Value: 0 - Maximum Value: 4, Higher Score = Worse Outcome.
Time frame
It will be assessed at baseline before beginning the intervention, and after the end of intervention (4 weeks later).3
Upper limb functional independence
Functional Independence Measure (FIM), Minimum Value: 18 - Maximum Value: 126, Higher Score = Better Outcome.
Time frame
It will be assessed at baseline before beginning the intervention, and after the end of intervention (4 weeks later).4
Upper limb functional independence.
Motor Activity Log (MAL-30), Minimum Value: 0 - Maximum Value: 150, Higher Score = Better Outcome.
Time frame
It will be assessed at baseline before beginning the intervention, and after the end of intervention (4 weeks later).Sponsors and contacts
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Source ClinicalTrials.gov