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

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Mexico
Instituto Nacional de Rehabilitación Luis Guillermo Ibarra Ibarra
RECRUITING
Mexico City
Contact Information
Primary
Jimena Quinzaños Fresnedo, MD, PhD
jquinzanos@inr.gob.mx
+52 5559991000
Backup
Gabriel Manrique Gutiérrez, MD/PhDc
gabriel.manrique.gtz@gmail.com
+52 4772842455
Time Frame
Start Date: 2024-08-06
Estimated Completion Date: 2026-06
Participants
Target number of participants: 26
Treatments
Experimental: Experimental Group
The experimental group will receive both Functional Electrical Stimulation therapy coupled to the P300-based Brain-Computer Interface system and conventional physical therapy.
Active_comparator: Control Group
The control group will receive double conventional physical therapy to equalize the time dosages received by the experimental group.
Related Therapeutic Areas
Sponsors
Leads: Instituto Nacional de Rehabilitacion

This content was sourced from clinicaltrials.gov

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