Longitudinal Validation of Neurofeedback in Stroke Motor Rehabilitation Through Brain Imaging

NCT ID: NCT04376138

Last Updated: 2024-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-17
• Study Completion Date: 2023-12-31

Brief Summary

With the main goal of generalising findings into Virtual Reality-Neurofeedback-Motor imagery (VR-NF-MI) system, this project aims to develop a new motor rehabilitation tool, for the upper limb, allied to the use of rising of information and communication technologies (ICT). By identifying correlations on the neural activity, during motor imagery and through brain imaging (fMRI), with distinct training protocols and feedback, these protocols are developed to create user-specific models that later can be used in NF-MI rehabilitation sessions.

Detailed Description

Every year millions of people worldwide suffer from stroke, being one of the leading causes of death and longterm disability. This leads to cognitive and motor impairments, resulting in loss of independence in their daily life together with an additional psychological impact in mood disorders and depression. Evolving to a chronic condition, stroke requires continuous rehabilitation and therapy. Personalised Virtual-Reality (VR) approaches have been shown to accelerate the recovery process compared to non-Information and communication technologies (ICT) based interventions. However, most of these novel VR approaches are suitable only for a reduced subset of patients, generally those with better recovery prognostics and better motor control. Thus, the idea of training the central nervous system was established, through EEG-based neurofeedback (NF) and motor-imagery (MI). Although the benefits of MI-NF have been illustrated in a plethora of studies, the reduced ability for stroke patients to use NF does not allow an accurate control, reducing the capabilities of MI-NF systems. The aim of this project is to develop a novel and more inclusive rehabilitation system with the use of novel ICT technologies, in order to overcome current limitations. This will be achieved by identifying the neural correlates of motor action during motor imagery through brain imaging (fMRI), and differences in brain activation with different training feedback protocols for formulating user-specific models that will be used later in NF-MI rehabilitation sessions. This will facilitate the use of neural interfaces to train the central nervous system; specifically, the investigators will develop a personalized EEG-based immersive NF through VR for MI training. The ultimate goal is to generalize the findings into a VR-NF-MI training paradigm for both admitted and ambulatory patients as well as continued domestic care.

Conditions

Stroke

Keywords

Brain Computer Interface; Virtual Reality; Stroke rehabilitation; Electroencephalography; Motor Imagery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Motor Imagery

A Brain-Computer Interaction (BCI) based intervention while receiving conventional therapy. Use of motor imagery training, allied with brain-computer interaction, as a solution to promote motor and cognitive gains in stroke survivors.

Group Type: EXPERIMENTAL

BCI intervention

Intervention Type: OTHER

30 minutes intervention that occurs 3 times per week, with a goal of 12 sessions total.

Conventional Therapy

Extra Occupational Therapy sessions while receiving conventional therapy. Use of conventional therapy techniques and tools for motor rehabilitation, following the original therapeutic intervention plan of the participants.

Group Type: ACTIVE_COMPARATOR

Conventional Therapy

Intervention Type: OTHER

30 minutes intervention that occurs 3 times per week, with a goal of 12 sessions total.

Interventions

BCI intervention

30 minutes intervention that occurs 3 times per week, with a goal of 12 sessions total.

Intervention Type: OTHER

Conventional Therapy

30 minutes intervention that occurs 3 times per week, with a goal of 12 sessions total.

Intervention Type: OTHER

Other Intervention Names

Brain Computer Interaction (BCI) and neurofeedback for stroke rehabilitation; Traditional motor rehabilitation for the upper limb

Eligibility Criteria

Inclusion Criteria

• First stroke episode
• More than six months after stroke
• Stroke hemiplegia/hemiparesis, (Fugl Meyer below or equal to 47)
• Capacity to understand and complete simple tasks
• Know how to read and write
• Motivation to participate

Exclusion Criteria

• Hemi spatial neglect
• Depressive symptoms, moderate to severe
• Presence of other neurological or orthopaedic problems
• Severe eyesight problems
• Claustrophobia
• Presence of ferromagnetic materials

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Serviço de Saúde da Região Autónoma da Madeira (SESARAM), E.P.E.

UNKNOWN

Sponsor Role: collaborator

Universidade da Madeira

OTHER

Sponsor Role: lead

Responsible Party

Sergi Bermúdez i Badia

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Serviço de Saúde da Região Autónoma da Madeira

Funchal, Madeira, Portugal

Countries

Portugal

Other Identifiers

031485

Identifier Type: -

Identifier Source: org_study_id