Brain Network Models of Motor Recovery After Stroke

NCT03784534 | Completed DMC

• 2 other identifiers: C17-752018-A02765-50
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

As with other real=world connected systems, studying the network structure of multiple interactions in the brain (holism versus reductionism) has profound implications in the comprehension of emergent complex phenomena like, for example, the capability to functionally reorganize after cerebrovascular "attacks" or stroke. This dynamic skill, which is known in neuroscience as brain plasticity, is not only interesting from a network perspective, but it also plays a crucial role in determining the motor/cognitive recovery of patients who survive a stroke. Network analysis of functional connectivity (FC) patterns estimated from neuroimaging techniques such as electroencephalography (EEG), magnetoencephalography (MEG) and functional magnetic resonance imaging (fMRI) has allowed a major breakthrough in the understanding of physiopathology of stroke from a system perspective. Recent evidence from cross=sectional studies1,2 highlights that stroke lesions generally induce i) critical deviation from optimal (i.e. small=world) network topologies supporting both segregated and integrated information processing, ii) altered inter=hemispheric connectivity and modularity, iii) and abnormal region centrality in the ipsilesional hemisphere as well as in the contralesional hemisphere. While these findings provide new descriptors on how stroke lesions affect the functional brain network organization and how this correlates with the resulting behavioral impairment (e.g. hemiplegia, aphasia), they only represent a static picture of the brain plasticity, which is instead intrinsically dynamic, and partially inform on the chances of single patients to recover their motor/cognitive functions. These aspects dramatically limit the investigator's ability to fully understand the brain organizational mechanisms after stroke and to probe the predictive power of possible network=based neuromarkers of recovery. The ATTACK project aims to overcome these technological and methodological barriers by implementing the following three=fold strategy:

1. 1.acquiring a longitudinal dataset of brain and behavioral data in stroke patients and healthy controls,
2. 2.developing new analytic tools to characterize and generate temporally dynamic brain networks,
3. 3.building network=based models of functional recovery after stroke, accounting for individual patients.

Conditions

Stroke

Keywords

EEG; Recovery; Motor

Outcome Measures

Primary Outcomes (3)

• Predictive value of EEG biomarkers on upper limb motor recovery (at 1 year)

  EEG centrality in M1 (arbitrary unit: \[0-1\])

  1 year

• Predictive value of EEG biomarkers on upper limb motor recovery (at 1 year)

  onnectivity indice: density of connectivity between cerebral hemispheres (arbitrary unit: \[0-1\])

  1 year

• Predictive value of EEG biomarkers on upper limb motor recovery (at 1 year)

  connectivity indice: network efficiency determined by areas topological distance (arbitrary unit: \[0-1\])

  1 year

Secondary Outcomes (3)

• Describe the changes in EEG connectivity during motor recovery

  1 year

• Describe the changes in EEG connectivity during motor recovery

  1 year

• Describe the changes in EEG connectivity during motor recovery

  1 year

Study Arms (2)

Healthy volunteers

EXPERIMENTAL

Subjects will be asked to perform: * high= density (64 sensors) EEG * clinical and behavioral data will be also collected from each subject to evaluate their motor skills: the ARAT or ACTION RESEARCH ARM TEST, hand grip strength, Fugl Meyer * anatomical MRI (T1 and tensor imaging) scan)

Other: Imaging; Behavioral: Clinical and behavioral testing : Motor skills

Patients

EXPERIMENTAL

Patients will be asked to perform: * high= density (64 sensors) EEG * clinical and behavioral data will be also collected from each patient to assess their motor recovery progress: the ARAT or ACTION RESEARCH ARM TEST, hand grip strength, NIHSS with motor subitems and Rankin and Barthel score, measure of functional independence and Hemispatial neglect, Fugl Meyer, test of Ashworth * anatomical MRI (T1 and tensor imaging) scan)

Other: Imaging; Behavioral: Clinical and behavioral testing : Motor recovery progress; Behavioral: Clinical and behavioral testing : Motor skills

Interventions

Imaging OTHER

high= density (64 sensors) EEG and anatomical MRI (T1 and tensor imaging) scan

Healthy volunteers; Patients

Clinical and behavioral testing : Motor recovery progress BEHAVIORAL

NIHSS with motor subitems and Rankin and Barthel score, measure of functional independence and Hemispatial neglect, test of Ashworth

Patients

Clinical and behavioral testing : Motor skills BEHAVIORAL

the ARAT or ACTION RESEARCH ARM TEST, hand grip strength, Fugl Meyer

Healthy volunteers; Patients

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First ever stroke
• Upper limb motor deficit assessed by the Fugl Meyer score
• Written consent given
• French health insurance
• MMSE score \> 26 for healthy volunteers

You may not qualify if:

• Aged 18 to 85 years
• Contra indication for MRI, unwilling to be informed a brain abnormality discovered on MRI other than the known one
• Life threatening condition during the year of follow up
• Surgery of the upper limb that impact the functional abilities
• Pregnancy, people under legal guardian
• Rankin score \> 2 before the stroke
• Subjects already involved in a therapeutic trial
• Territorial sequelae old to the imagery

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

Urgences cérébro-vasculaires, Hôpital Pitié-Salpêtrière

Paris, 75013, France

Location

MeSH Terms

Conditions

Stroke

Interventions

X-Rays

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Pathophysiological and longitudinal study with no therapeutic intervention

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: December 24, 2018
• Study Start: September 4, 2019
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: March 28, 2025

Record last verified: 2025-03

Locations

FR (1)