Skip to content

Identification of Non-motor Brain Areas Involved in Upper Limb Motor Recovery After Stroke

Identification of Non-motor Brain Areas Involved in Upper Limb Motor Recovery After Stroke

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05313776
Acronym
NOMO-Stroke
Enrollment
28
Registered
2022-04-06
Start date
2022-02-07
Completion date
2025-06-13
Last updated
2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke, Upper Limb Ischemia

Keywords

Ischemic stroke, Motor recovery, Upper-limb, Functional MRI, Neuroplasticity

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.

Detailed description

Patients' brain activity and connectivity during an elbow flexion/extension task will be evaluated at 2 weeks (V0), 3 months (V1) and 6 months (V2) post-stroke. Between V0 and V1, patients will receive standard in-care rehabilitation at the physical and rehabilitation medicine department (PMR) of Montpellier's University Hospital: 120 minutes a day, for 5 days/week (orthopedic training, sitting/standing balance, walking, sensorimotor training - including 2 and 3 dimensional reach to grasp exercises with and without vision, functional electrical stimulation of the upper-limb, finger pinching exercises). On the day of imaging, a clinical evaluation will be performed to evaluate patients upper-limb function (Fugl-Meyer Upper Extremity scale) and capacity (WOLF motor function test & Box and Block test). The imaging protocol includes a 3DT1 for anatomical reference, a functional task-based MRI with block-design (30s rest alternated with 30s of activity) and diffusion tensor imaging (DTI) to quantify anatomical connectivity. During imaging, participants will lay on their back with their arm stretched along their body. A short auditory signal will inform patient when to start/stop moving. During movement, only the elbow will be rhythmically flexed and extended at a self-selected comfortable pace in the vertical plane. The motor task will be performed with both the paretic and ipsilesional upper-limb, in random order. Patients that are unable to move, will be asked to keep trying to move during the activity block. Material: 3.0T whole-body magnet MRI (Prisma Siemens, Germany), MRI compatible 3D motion camera's (Qualisys, France). Imaging data will be acquired by the I2FH research platform at the Montpellier University Hospital Data treatment: functional Imaging data will be preprocessed following standard procedures, including reorientation to the anterior commissure, slice-time correction, realignment, co-registering & normalization to 3DT1 anatomical template, smoothing. Subsequent group analyses using general linear models, will be corrected for multiple comparisons. Imaging data will be analyzed by the I2FH research platform. 3D-Movement time-series of upper-limb displacement will be analyzed by Euromov, using matlab the mathworks. The movement will be quantified by its shaping (e.g. Amplitude/Frequency) and structure (e.g. Fluency/Directness). Clinical testing will be performed as part of standard care evaluations at the physical rehabilitation medicine department of the hospital of Montpellier and Nimes. Schedule visit: Patients: V0: \ 10 post-stroke, V1: \ 3 months post-stroke, V2: \ 6 months post stroke. Clinical testing will be performed on the day (+/- 1) of the MRI session. Healthy subjects will be evaluated once

Interventions

OTHERMagnetic Resonance Imaging

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.

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER
Centre Hospitalier Universitaire de Nīmes
CollaboratorOTHER
Euromov, Université Montpellier
CollaboratorUNKNOWN
IMT Mines Ales
CollaboratorUNKNOWN

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

Inclusion criteria

patients post-stroke: * 18-85 yrs, * First ever ischemic stroke of the middle cerebral artery, * Initial severe motor deficit (fugl-Upper limb assessment score \<30/66), * Written consent.

Exclusion criteria

patients post-stroke: * 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. Inclusion criteria healthy subjects: * Age matching (+/- 5 yrs), * Sexe matching, * Written consent.

Design outcomes

Primary

MeasureTime frameDescription
Change of brain activity during motor task during post-stroke recovery~10days, 3 months and 6 months post-stroke.Functional MRI imaging with upper-limb elbow flexion in a blocked-design. Analysis with integrated movement kinematics that are registered simulateously.

Secondary

MeasureTime frameDescription
fMRI task-based and resting state brain connectivityat ~10days, 3 months and 6 months post-stroke.Resting-state and functional MRI with upper-limb elbow flexion
Diffusion Tensor Imaging anatomical brain connectivityat ~10days, 3 months and 6 months post-stroke.DTI imaging

Countries

France

Contacts

PRINCIPAL_INVESTIGATORIsabelle LAFFONT, PHD,MD

Montpellier University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026