NCT06160453

Brief Summary

HEROES is a multidisciplinary neurophysiological \& neural rehabilitation engineering project, developed by the Lab of Medical Physics \& Digital Innovation, School of Medicine, Faculty of Health Science Aristotle University of Thessaloniki and supported by a Neurosurgical Department. The website for the project can be accessed at https://heroes.med.auth.gr. The investigation's primary objectives include the development, testing and optimization of an intervention based on multiple immersive man-machine interfaces offering rich feedback, that include a) mountable robotic arm controlled with wireless Brain-Computer Interface and b) wearable robotics jacket \& gloves in combination with a serious game application and c) augmented reality module for the presentation of the previous two, as well as the development and validation of a self-paced neuro-rehabilitation protocol for patients after chronic stroke with severe residual motor disability.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 7, 2023

Completed
12 months until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

July 17, 2024

Status Verified

July 1, 2024

Enrollment Period

1.1 years

First QC Date

November 29, 2023

Last Update Submit

July 16, 2024

Conditions

Stroke

Keywords

Chronic StrokeMotor disabilityRehabilitationNeuroplasticityRoboticsWearables

Outcome Measures

Primary Outcomes (2)

  • BCI control

    The ability of participants to modulate brainwave activity in order to achieve control of the BCI will be established. BCI control is evaluated as achieved or not (there are cases of BCI-illiteracy when the participants cannot modulate their brainwaves in order to control the BCI).

    1 week

  • Serious game performance (in-game scoring system)

    The ability of participants to control the wearables robotic jacket in order to complete in-game tasks and collect more points will be evaluated. The points will be gathered be matching the speed and position of the in-game task instructions while receiving assistance from electrical muscle stimulation.

    2 weeks

Secondary Outcomes (1)

  • Initial Functional Improvement (Greek translation of the Modified Rankin Scale (mRS-9Q)

    12 months

Study Arms (3)

Stroke with upper limb monoparesis or hemiparesis

EXPERIMENTAL

Patients from Greece, 18 y.o. or older, suffering from chronic stroke and motor disability

Device: Brain-Computer Interface control of robotic arms with augmented realityDevice: Serious game with augmented reality

Stroke with monoplegia or hemiplegia

EXPERIMENTAL

Patients from Greece, 18 y.o. or older, suffering from chronic stroke and motor disability

Device: Brain-Computer Interface control of robotic arms with augmented realityDevice: Serious game with augmented reality

Healthy Participants

ACTIVE COMPARATOR

Healthy participants, age and sex matched to the participants in the other arms

Device: Brain-Computer Interface control of robotic arms with augmented realityDevice: Serious game with augmented reality

Interventions

Brain-Computer Interface control of robotic arms with augmented realityDEVICE

The participants will be trained to modulate self-paced Visual Motor Imagery (VMI) and Kinesthetic Motor Imagery (KMI) under EEG recording in order to achieve BCI-control of a custom-built bimanual arms robot (MERCURY v2.0). In KMI they will be asked to modulate brain waves in order to learn to control the BCI and in VMI they will additionally be projected a visual cue (representation of the intended movement). BCI will be used to control the arms in physical space as well as in an Augmented Reality Environment. Each participant will take part in 3 sessions

Healthy ParticipantsStroke with monoplegia or hemiplegiaStroke with upper limb monoparesis or hemiparesis
Serious game with augmented realityDEVICE

The participants will don wearable robotics and use them as input to play a dojo-themed immersive serious game intended at tracking participants movement and presenting them with motor tasks to perform. The game will be played in a computer screen, as well as in an Augmented Reality Environment. Each participant will take part in 10 sessions

Healthy ParticipantsStroke with monoplegia or hemiplegiaStroke with upper limb monoparesis or hemiparesis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 14 years of age
  • Female \& male stroke survivors and healthy individuals (age and gender matched)
  • Sufficient documentation of stroke in case of patients (clinical neurological examination, MRI)

You may not qualify if:

  • Other neurological condition that has a possibility to significantly affect the neurological status of the participants (or) the ability to control a BCI (or) the neurophysiological recordings:
  • Traumatic brain injury
  • Central Nervous System tumors
  • Multiple Sclerosis
  • Amyotrophic Lateral Sclerosis
  • Parkinson's disease
  • Refractory Epilepsy
  • Other grave medical condition that could affect the participation (or) the safety of the participants:
  • Cardiac deficiency
  • Pulmonary deficiency
  • Hearing and visual impairments that can affect the participant's understanding of the --intervention and performance.
  • Illegal drug use
  • Chronic alcoholism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory of Medical Physics and Digital Innovation, AUTH

Thessaloniki, 54636, Greece

Location

Related Links

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Panos D Bamidis, PhD

    Aristotle University Of Thessaloniki

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alkinoos Athanasiou, PhD

CONTACT

00302310999237athalkinoos@auth.gr

Panos D Bamidis, PhD

CONTACT

00302310999237bamidis@auth.gr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Participants are assigned to one of two or more groups in parallel for the duration of the study (Parallel Assignment)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 29, 2023

First Posted

December 7, 2023

Study Start

December 1, 2024

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

July 17, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will share

Anonymized data will be made available after a Memorandum of Understanding agreement between the Medical Physics and Digital Innovation lab of Aristotle University of Thessaloniki and any interested party.

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
Data will be made available 2 years after the conclusion of the study

Locations

GR(1)