Upper Limb IschemiaNOMO-StrokeNCT05313776
Identification of Non-motor Brain Areas Involved in Upper Limb Motor Recovery After Stroke
An observational study of Upper Limb Ischemia and Stroke, run by University Hospital, Montpellier at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Limb Ischemia, Stroke
- What is being tested?
- Magnetic Resonance Imaging
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- 7 Feb 2022to 13 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients admitted at the University hospital of Montpellier with an ischemic stroke that are meeting the inclusion criteria.
Who may be able to join
- 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.
- Age matching (+/- 5 yrs),
- Sexe matching,
- Written consent.
Who cannot join
- 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,
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- Pregnancy/breastfeading,
- Patient under curatele,
- Medical urgency.
- Neurological or psychological deficits;
- MRI contra-indations;
- Pregnancy/breastfeeding,
- Personunder curatele.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Upper Limb Ischemia, Stroke
- Being tested
- Magnetic Resonance Imaging
- Keywords
- Ischemic stroke, Motor recovery, Upper-limb, Functional MRI, Neuroplasticity
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Magnetic Resonance Imaging | |
| Controls | Age and sexe matched healthy subjects without known neurological and or psychological deficits. Receives: Other: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: ~10days, 3 months and 6 months post-stroke.
Secondary outcomes (2)
fMRI task-based and resting state brain connectivity
Resting-state and functional MRI with upper-limb elbow flexion
Measured: at ~10days, 3 months and 6 months post-stroke.
Diffusion Tensor Imaging anatomical brain connectivity
DTI imaging
Measured: at ~10days, 3 months and 6 months post-stroke.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start7 Feb 2022
- Primary completion13 Jun 2025
- Study completion13 Jun 2025
Why it stopped: lack of recruitement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Upper Limb IschemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Nīmes, Euromov, Université Montpellier, IMT Mines Ales
- Responsible party
- Sponsor
- Investigators
- Isabelle LAFFONT, PHD,MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05313776
- Sponsor's protocol ID
- RECHMPL20_0431
- Acronym
- NOMO-Stroke
- Status last verified
- Apr 2026
- First submitted
- 23 Feb 2022
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Belkacemi Z, Van Dokkum L, Deverdun J, Tchechmedjiev A, Rouges C, Troalen T, Laffont I, Mottet D, Le Bars E. How to integrate simultaneously recorded Kinematic into an individual fMRI Motor Task Analysis?. Annu Int Conf IEEE Eng Med Biol Soc. 2025 Jul;2025:1-7. doi: 10.1109/EMBC58623.2025.11253807.
PubMed 41337196
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Non-motor Brain Areas Involved in Upper Limb Motor Recovery After Stroke
- ClinicalTrials.gov ID
- NCT05313776
- Acronym / sponsor ID
- NOMO-Stroke / RECHMPL20_0431
- Conditions
- Upper Limb Ischemia, Stroke
- Keywords
- Ischemic stroke, Motor recovery, Upper-limb, Functional MRI, Neuroplasticity
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: lack of recruitement
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Nīmes, Euromov, Université Montpellier, IMT Mines Ales
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 13 Jun 2025 (actual)
- Study completion
- 13 Jun 2025 (actual)
- First posted
- 6 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-stroke | – | Other: Magnetic Resonance ImagingPeople with a first ever ischemic stroke of the middle cerebral artery presenting severe motor deficits of the upper-limb at onset. The patients |
| Controls | – | Other: Magnetic Resonance ImagingAge and sexe matched healthy subjects without known neurological and or psychological deficits. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted at the University hospital of Montpellier with an ischemic stroke that are meeting the inclusion criteria.
Key inclusion criteria (7 listed)
- 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.
- Age matching (+/- 5 yrs),
Key exclusion criteria (13 listed)
- The presence of secondary neurological or psychiatric deficits,
- Strong hemineglect (bell-test);
- Aphasie >3/5 on the Boston scale,
- Bilateral stroke,
- Hemorraghic stroke,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance ImagingIMR 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. | Other | Controls, Post-stroke |
Primary outcome
Change of brain activity during motor task during post-stroke recovery
Time frame: ~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.
2 secondary outcomes
fMRI task-based and resting state brain connectivity
Time frame: at ~10days, 3 months and 6 months post-stroke.
Diffusion Tensor Imaging anatomical brain connectivity
Time frame: at ~10days, 3 months and 6 months post-stroke.
Results and safety
The study was stopped early (reason given: lack of recruitement). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Results publication: PubMed 41337196Belkacemi Z, Van Dokkum L, Deverdun J, Tchechmedjiev A, Rouges C, Troalen T, Laffont I, Mottet D, Le Bars E. How to integrate simultaneously recorded Kinematic into an individual fMRI Motor Task Analysis?. Annu Int Conf IEEE Eng Med Biol Soc. 2025 Jul;2025:1-7. doi: 10.1109/EMBC58623.2025.11253807.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle LAFFONT, PHD,MD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Limb Ischemia and Stroke, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: lack of recruitement). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of brain activity during motor task during post-stroke recovery (time frame: ~10days, 3 months and 6 months post-stroke.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05313776, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.