Longitudinal Validation of Neurofeedback in Stroke Motor Rehabilitation Through Brain Imaging

NCT04376138 | Completed

• 1 other identifier: 031485
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Change from the baseline in the functional magnetic resonance imaging (fMRI)

  Analyze cortical activation, during motor imagery exercises, and cortical structure.

  Baseline, Final (4 weeks) and 1 month follow up

• Change from the baseline in the Fugl Meyer Motor Assessment

  Evaluates the motor function of the affected upper limb. This section has a maximum score of 66 and changes to a higher score means an evolution on motor recovery.

  Baseline, Final (4 weeks) and 1 month follow up

Secondary Outcomes (5)

• Change from the baseline in the electroencephalography (EEG) data

  In all 12 sessions for 4 weeks

• Change from the baseline in the Kinesthetic and Visual Imagery Questionnaire (KVIQ)

  Baseline, Final (4 weeks) and 1 month follow up

• Change from the baseline in the Montreal Cognitive Assessment (MoCA)

  Baseline, Final (4 weeks) and 1 month follow up

• Change from the baseline in the Modified Ashworth Scale (MAS)

  Baseline, Final (4 weeks) and 1 month follow up

• Change from the baseline in the Geriatric Depression Scale (GDS)

  Baseline, Final (4 weeks) and 1 month follow up

Study Arms (2)

Motor Imagery

EXPERIMENTAL

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.

Other: BCI intervention

Conventional Therapy

ACTIVE COMPARATOR

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.

Other: Conventional Therapy

Interventions

BCI intervention OTHER

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

Also known as: Brain Computer Interaction (BCI) and neurofeedback for stroke rehabilitation

Motor Imagery

Conventional Therapy OTHER

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

Also known as: Traditional motor rehabilitation for the upper limb

Conventional Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universidade da Madeira: lead
• Serviço de Saúde da Região Autónoma da Madeira (SESARAM), E.P.E.: collaborator

Study Sites (1)

Serviço de Saúde da Região Autónoma da Madeira

Funchal, Madeira, 9004-514, Portugal

Location

MeSH Terms

Conditions

Stroke

Interventions

2-benzylidene-3-(cyclohexylamino)-2,3-dihydro-1H-inden-1-one; Neurofeedback; Stroke Rehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological; Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: May 6, 2020
• Study Start: August 17, 2019
• Primary Completion: December 30, 2023
• Study Completion: December 31, 2023
• Last Updated: December 13, 2024

Record last verified: 2024-12

Locations

PT (1)