BCI-FES for Upper Limb Rehabilitation in Chronic Stroke - Trial NCT06409754

Timeline & Enrollment

Primary Outcome

Upper limb motor recovery

Summary

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.

ICD-10 Classifications