NCT05313776

Brief Summary

Why: Upper-limb recovery post-stroke is challenging. Rehabilitation, aiming to induce plasticity takes an important place in patients' treatment. The last years, non-invasive brain stimulation of the primary motor cortex has gained the communities' interest, allowing direct modification of neural excitability and thus impacting plasticity. Yet, research outcomes remain inconclusive to date. It's expected this to be related to patient heterogeneity including mild to severe motor deficits, and suboptimal site of stimulation. It might be questioned whether M1 stimulation is preferable over that of higher association areas like the parietal or premotor cortex. What: The aim of the study is to identify alternative brain regions to stimulate, related to improved motor quality after a severe initial deficit. How: by following motor recovery over time, by co-recording movement kinematics and brain activity. Because: Stimulation of the novel identified regions may improve motor recovery after stroke.

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

February 7, 2022

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 6, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

March 9, 2023

Status Verified

March 1, 2023

Enrollment Period

1.8 years

First QC Date

February 23, 2022

Last Update Submit

March 8, 2023

Conditions

Upper Limb IschemiaStroke

Keywords

Ischemic strokeMotor recoveryUpper-limbFunctional MRINeuroplasticity

Outcome Measures

Primary Outcomes (1)

  • Change of brain activity during motor task during post-stroke recovery

    Functional MRI imaging with upper-limb elbow flexion in a blocked-design. Analysis with integrated movement kinematics that are registered simulateously.

    ~10days, 3 months and 6 months post-stroke.

Secondary Outcomes (2)

  • fMRI task-based and resting state brain connectivity

    at ~10days, 3 months and 6 months post-stroke.

  • Diffusion Tensor Imaging anatomical brain connectivity

    at ~10days, 3 months and 6 months post-stroke.

Study Arms (2)

Post-stroke

People with a first ever ischemic stroke of the middle cerebral artery presenting severe motor deficits of the upper-limb at onset. The patients

Other: Magnetic Resonance Imaging

Controls

Age and sexe matched healthy subjects without known neurological and or psychological deficits.

Other: Magnetic Resonance Imaging

Interventions

Magnetic Resonance ImagingOTHER

IMR is a non-invasive imaging technology that produces three dimensional detailed anatomical images. It is often used for disease detection, diagnosis, and treatment monitoring. It is based on sophisticated technology that excites and detects the change in the direction of the rotational axis of protons found in the water that makes up living tissues.

ControlsPost-stroke

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients admitted at the University hospital of Montpellier with an ischemic stroke that are meeting the inclusion criteria.

You may qualify if:

  • yrs,
  • First ever ischemic stroke of the middle cerebral artery,
  • Initial severe motor deficit (fugl-Upper limb assessment score \<30/66),
  • Written consent.

You may not qualify if:

  • The presence of secondary neurological or psychiatric deficits,
  • Strong hemineglect (bell-test);
  • Aphasie \>3/5 on the Boston scale,
  • Bilateral stroke,
  • Hemorraghic stroke,
  • MRI contra-indications,
  • Pregnancy/breastfeading,
  • Patient under curatele,
  • Medical urgency.
  • Age matching (+/- 5 yrs),
  • Sexe matching,
  • Written consent.
  • Neurological or psychological deficits;
  • MRI contra-indations;
  • Pregnancy/breastfeeding,
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montpellier University Hospital

Montpellier, 34090, France

RECRUITING

MeSH Terms

Conditions

StrokeIschemic Stroke

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Isabelle LAFFONT, PHD,MD

    Montpellier University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabelle LAFFONT, PHD,MD

CONTACT

0467338664I-laffont@chu-montpellier.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2022

First Posted

April 6, 2022

Study Start

February 7, 2022

Primary Completion

December 1, 2023

Study Completion

June 1, 2024

Last Updated

March 9, 2023

Record last verified: 2023-03

Locations

FR(1)