Motor Imagery BCI Rehabilitation After Stroke

NCT04847089 | Completed DMC

• 1 other identifier: 2021-01075
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 3

Brief Summary

This research project will investigate motor imagery training in stroke rehabilitation during which patients receive feedback in real time from their brain activity measured with ElectroEncephaloGraphy (EEG). The investigators hypothesize that the feedback training allows to internally stimulate brain motor networks in order to promote functional recovery of the hand.

Conditions

Stroke; Hemiparesis

Outcome Measures

Primary Outcomes (3)

• Change of Fugl-Meyer Upper Extremity scale score (0-66 points)

  Arm and hand function

  Up to 10 weeks

• Change of EEG alpha and beta activity

  Brain motor network activity reflected in BCI feedback

  Up to 10 weeks

• Change of fMRI BOLD activity

  Brain motor network activity

  Up to 10 weeks

Secondary Outcomes (5)

• Change of monofilament test score

  Up to 10 weeks

• Change of box and block test score (0-150)

  Up to 10 weeks

• Change of JAMAR® digital Hand Dynamometer scores (0-90)

  Up to 10 weeks

• Change of visuomotor force-tracking task scores

  Up to 10 weeks

• Change of stroke Impact Scale 16 scores (15-80 points)

  Up to 10 weeks

Study Arms (1)

Motor Imagery BCI training

EXPERIMENTAL

Complete intervention with motor imagery BCI training. Patients recruited by physiotherapists who underwent baseline evaluations with clinical tests, fMRI and EEG measurements. Patients will after intervention perform clinical tests, fMRI, and EEG measurements to evaluate outcomes of intervention.

Device: Motor imagery BCI training

Interventions

Motor imagery BCI training DEVICE

Motor Imagery (MI)-BCI training, 2-3 hours, 3 times/week for 4 weeks.

Motor Imagery BCI training

Eligibility Criteria

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

You may qualify if:

• \> 6 months since first time stroke onset and with remaining hemiparesis in upper extremity; able to participate fully in the intervention, able to perform Functional Magnetic Resonance Imaging (fMRI); able to passively extend the wrist 15 degrees and extend fingers fully with a neutral position of the wrist.
• In addition, participants need to be able to voluntarily control the power of their grip when requested according to the Visuomotor force tracking method and/or according to the clinical assessment of a therapist (while holding the patient´s hand). According to the Fugl- Meyer Upper Extremity (UE) scale participants should accomplish \<14 points on the hand subscale and \<2 points in finger flexion and extension (C) in addition to \< 47 points on the total motor score (equivalent to moderate disability in the upper extremity.

You may not qualify if:

• other neurological or musculoskeletal disease/injury, or contagious disease.
• If the research person is regularly treated with botulinum toxin in the upper extremity, 3 weeks should have passed before the first baseline assessment.
• current or history of epilepsy,
• severe hearing or visual impairments,
• metal implants in the brain/skull cochlear implants,
• any implanted neurostimulator, cardiac pacemaker or cardiac implants of metal, infusion device,
• any other neurological disorder,
• pregnancy,
• current or history of severe psychiatric disorder with need for pharmacological treatment

Sponsors & Collaborators

• Danderyd Hospital: collaborator
• Mälardalen University: lead

Study Sites (3)

Stockholn University Brain Imaging Centre

Stockholm, 11418, Sweden

Location

Department of rehabilitation medicine at Danderyd University

Stockholm, 18288, Sweden

Location

Sweden Mälardalen University

Västerås, 72123, Sweden

Location

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Elaine Astrand, PhD

  Mälardalen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 15, 2021
• Study Start: April 14, 2022
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)