Brain DiseasesSPECTRENCT06784518
Stroke Cerebral Reorganization Pathways (SPECTRE)
A study testing Clinical scores and functional MRI in people with Brain Diseases and Ischemic Stroke, run by Rennes University Hospital at 1 site in France.
Trial summary
SPECTRE is a prospective longitudinal study in order to identify whether patients with different degrees of motor recovery are distinguished by distinct brain post-stroke plasticity patterns in the acute and sub-acute phases. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Brain Diseases, Ischemic Stroke, Stroke
- What is being tested?
- Clinical scores and functional MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2026to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (age greater than or equal to 18 years) less than 75 years of age, both sexes;
- single supratentorial ischemic stroke confirmed by brain imaging
- Upper limb deficit defined by a SAFE score <5 (SAFE Stinear protocol, prognosis of post-stroke upper limb recovery) on D3 of stroke. This corresponds to the sum of shoulder abduction and finger extension according to the MRC (Medical Research Council) scale for each of these movements out of 5.
- Absence of comprehension disorders limiting participation;
- Patient covered by french social security;
- Free, informed and written consent signed by the patient or a member of the patient's family (in the case of a patient who is able to understand the information and give consent but has motor difficulties resulting in an invalid signature).
Show all 18Show fewer
- Non-Inclusion Criteria:
- Multiple ischemic strokes or history of clinically significant stroke ;
- Posterior fossa stroke ;
- Hemorrhagic stroke;
- Patient who have undergone thrombolysis or mechanical thrombectomy;
- Extensive Fazekas grade 3 vascular leukopathy;
- Pre-existing neurodegenerative pathology;
- Patient with severe dyspnea or swallowing disorders who cannot undergo brain MRI;
- Adults under legal protection (safeguard of justice, curatorship, guardianship, family habilitation), persons deprived of liberty;
- Women declaring that they are pregnant or breast-feeding;
- Patient participating in another therapeutic or drug intervention study that may have an impact on the effect of cerebral neuroplasticity on the SPECTRE study;
- Patients with contraindications to MRI pacemaker or implantable defibrillator, neurosurgical clips, cochlear implants, intra-orbital or encephalic metallic foreign bodies, stents placed less than 4 weeks ago and osteosynthesis devices placed less than 6 weeks ago, claustrophobia.
Who cannot join
- If the prognostic group according to the PREP2 algorithm (good, limited and poor) has already been reached during motor evoked potential assessment the patient is excluded.
- Recurrence of clinically significant stroke (with worsening NIHSS score > 4) during study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Rennes Chu
Rennes, France, 35033
Maud GUILLEN, Md, 299284122 ext. +33, maud.guillen@chu-rennes.fr
Maud GUILLEN, Md
About this study
Official title: Stroke Cerebral Reorganization Pathways Longitudinal Study After Stroke of the Clinical Motor Pattern and the Cerebral Reorganization According to the Different Damaged Motor Pathways (Main and Accessory) (SPECTRE)
SPECTRE is a prospective longitudinal study in order to identify whether patients with different degrees of motor recovery are distinguished by distinct brain post-stroke plasticity patterns in the acute and sub-acute phases. This study allows close longitudinal follow-up of patients with severe clinical motor impairment using functional MRI to study cerebral neuroplasticity after ischemic stroke in the acute and sub-acute phase in patients with upper limb motor impairement, taking into account prognostic criteria used in current practice.
Read the detailed description
Patients are recruited as they are admitted to the neurovascular department. The SAFE score from the Stinear study is taken on Day 3 of the stroke, followed by motor evoked potentials between Day 3-Day 7 of the stroke, for a equal distribution of patients into three prognostic groups according to the PREP2 algorithm (good, limited and poor).
Longitudinal follow-up with clinical scores and functional MRI at Day 7-Day 10, Day 30, Month 3 and Month 6 of stroke.
Patients will ultimately be classified and analyzed according to their effective motor recovery at 6 months, using the Fugl-Meyer score.
The investigators will then conduct a comprehensive analysis of brain connectivity, examining both the anatomical structure of the brain, its functional activity and the dynamic interactions between certain regions of interest over time.
- Conditions
- Brain Diseases, Ischemic Stroke, Stroke, Brain Infarction, Stroke Rehabilitation
- Being tested
- Clinical scores and functional MRI
- Keywords
- stroke, Rehabilitation, Upper Limb, Neuroplasticity, Connectivity
- Medical subject headings
- Brain Diseases, Ischemic Stroke, Stroke, Brain Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical scores and functional MRIOther
Motor evoked potentials between Day 3-Day 7 of the stroke, for a equal distribution of patients into three prognostic groups according to the PREP2 algorithm (good, limited and poor). Longitudinal follow-up with clinical scores and functional MRI at Day 7-Day 10, Day 30, Month 3 and Month 6 of stroke.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Three prognostic groups according to the PREP2 algorithm (good, limited and poor).
21 evaluable patients divided into 3 balanced prognostic groups. Receives: Other: Clinical scores and functional MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in effective connectivity of Brain data (fMRI activity and CST tractography)
Descriptive analysis of topological measures of effective connectivity graphs as a function of effective motor recovery (Fugl-Meyer score - Upper Extremity) at 6 months. The Fugl-Meyer upper limb motor subscale has a maximum score of 66.
The effective Fugl Meyer score classifies motor recovery into 3 categories (mild, moderate and severe). A Fugl Meyer score of 0-28 is classified as severe, 29-42 as moderate and 42-66 as mild.
Measured: 6 months
Secondary outcomes (20)
Changes in Effective connectivity of brain data
Longitudinal analysis of topological measures of effective connectivity graphs (between Region of interest (ROIs)) according to recovery categories defined by the Fugl-Meyer score.
Measured: From Day 7-Day 10 to 6 months
Changes in Structural connectivity of brain data
Analysis of topological measures of structural connectivity graphs according to recovery categories defined by the Fugl-Meyer score.
Measured: From Day7-Day 10 to 6 months
Changes in Modification of brain activity of brain data
Longitudinal analysis of brain activity (expressed as variation in BOLD hemodynamic response) at rest and during a motor task (between ROIs) according to recovery categories defined by the Fugl-Meyer score.
Measured: From Day 7-Day 10 to 6 months
Changes in Ipsilesional / contralesional laterality index of brain data
Longitudinal analysis of the ipsilesional/counterlesional laterality index of activations in sensorimotor areas according to recovery categories defined by the Fugl-Meyer score.
Measured: From Day 7-Day 10 to 6 months
Changes in perfusion of brain data
Longitudinal analysis of perfusion (infratentorial, interhemispheric, intrahemispheric) according to recovery categories defined by the Fugl-Meyer score.
Measured: From Day 7-Day 10 to 6 months
Changes in Degree of corticospinal FA ratio of brain data
Longitudinal analysis of the degree of FA ratio of the cortico-spinal tract (injured hemisphere / healthy hemisphere) according to the recovery categories defined by the Fugl-Meyer score.
Measured: From Day 7-Day 10 to 6 months
Changes in patients' clinical profile in terms of motricity
Changes in Motor scores Motor index for upper and lower limbs according to recovery categories defined by the Fugl-Meyer score.
The Motricity Index can be used to assess the motor impairment in a patient who has had a stroke. This test includes a motor test on the upper limb with a score from 0 to 100, combined with a motor test on the lower limb with a score from 0 to 100. The sum of these two scores is divided by 2 for a total out of 100. A high score indicates good recovery."
Measured: 6 months
Changes in patients' clinical profile in terms of motricity
Changes in Action Research Arm Test (ARAT) score according to recovery categories defined by the Fugl-Meyer score.
The total score on the ARAT ranges from 0 to 57, with the lowest score indicating that no movements can be performed, and the upper score indicating normal performance. Thus, higher scores will indicate better performance. The ARAT scores is a continuous measure, with no categorical cutoff scores.
Measured: 6 months
Changes in patients' clinical profile in quality of life
Progression in The Stroke Impact Scale (SIS) score according to recovery categories defined by the Fugl-Meyer score.
The SIS contains 59 items measuring eight domains: strength (4 items), hand functionality (5 items), ADL / IADL (10 items), mobility (9 items), communication (7 items), emotions (9 items), memory / thinking (7 items), and social participation (8 items). A final item assessing overall stroke recovery is asked of the patient (score out of 100).
The minimum score is 60, the maximum is 300. A high score indicates a good quality of life.
Measured: 6 months
Changes in patients' clinical profile in independence
Progression in The Composite Functional Independence Scale (MIF) score according to recovery categories defined by the Fugl-Meyer score.
The MIF consists of 18 items measuring patients' performance in performance in activities of daily living, including cognitive and relational aspects. For each item (from 1 to 18), the therapist chooses the patient's level of incapacity from 1 (total assistance) to 7 (total independence). The total score is calculated by adding up the disability level figures for each item. The minimum score is 18, the maximum is 126. A high score indicates complete independence.
Measured: 6 months
Changes in patients' clinical profile in spasticity
Progression in Changes in Tardieu Scale according to recovery categories defined by the Fugl-Meyer score.
The Tardieu Scale are clinical measures of muscle spasticity in patients with neurological conditions. The Tardieu Scale quantify spasticity by assessing the muscle's response to stretch applied at given velocities. The examiner evaluates the muscle group's reaction to stretch at a specified velocity with 2 parameters: X (quality of muscle reaction) and Y (angle of muscle reaction).
Measured: 6 months
Changes in clinical profile in terms of motor skills
Changes in Fugl-Meyer Assesment - Upper Extremity (FMA-UE) according to recovery categories defined by the Fugl-Meyer score.
The FMA assesses motor impairment of the upper and lower limb, balance, sensitivity, passive joint mobility and pain on mobilization following stroke.
The Fugl-Meyer upper limb motor subscale has a maximum score of 66. The effective Fugl Meyer score classifies motor recovery into 3 categories (mild, moderate and severe). A Fugl Meyer score of 0-28 is classified as severe, 29-42 as moderate and 42-66 as mild.
Measured: Day 7-Day 10
Changes in clinical profile in terms of motor skills
Changes in Fugl-Meyer Assesment - Upper Extremity (FMA-UE) according to recovery categories defined by the Fugl-Meyer score.
The FMA assesses motor impairment of the upper and lower limb, balance, sensitivity, passive joint mobility and pain on mobilization following stroke.
The Fugl-Meyer upper limb motor subscale has a maximum score of 66. The effective Fugl Meyer score classifies motor recovery into 3 categories (mild, moderate and severe). A Fugl Meyer score of 0-28 is classified as severe, 29-42 as moderate and 42-66 as mild.
Measured: Day 30
Changes in clinical profile in terms of motor skills
Changes in Fugl-Meyer Assesment - Upper Extremity (FMA-UE) according to recovery categories defined by the Fugl-Meyer score.
The FMA assesses motor impairment of the upper and lower limb, balance, sensitivity, passive joint mobility and pain on mobilization following stroke.
The Fugl-Meyer upper limb motor subscale has a maximum score of 66. The effective Fugl Meyer score classifies motor recovery into 3 categories (mild, moderate and severe). A Fugl Meyer score of 0-28 is classified as severe, 29-42 as moderate and 42-66 as mild.
Measured: 3 months
Changes in clinical profile in terms of motor skills
Changes in Fugl-Meyer Assesment - Upper Extremity (FMA-UE) according to recovery categories defined by the Fugl-Meyer score.
The FMA assesses motor impairment of the upper and lower limb, balance, sensitivity, passive joint mobility and pain on mobilization following stroke.
The Fugl-Meyer upper limb motor subscale has a maximum score of 66. The effective Fugl Meyer score classifies motor recovery into 3 categories (mild, moderate and severe). A Fugl Meyer score of 0-28 is classified as severe, 29-42 as moderate and 42-66 as mild.
Measured: 6 months
Changes in clinical profile in terms of of global impairment
Changes in National Institutes of Health Stroke Scale (NIHSS) according to recovery categories defined by the Fugl-Meyer score.
This scale assesses level of consciousness, extraocular movements, field of vision, facial muscle function, extremity strength, sensory function, coordination (ataxia), language (aphasia), speech (dysarthria) and hemineglect (neglect). Total NIHSS scores range from 0 to 42, with higher values reflecting more severe brain damage. Stroke severity is defined according to threshold scores as follows: > 25 - severe neurological deficits, 5-14 - moderate neurological deficits, < 5 - mild deficits.
Measured: Day 7-Day 10
Changes in clinical profile in terms of of global impairment
Changes in National Institutes of Health Stroke Scale (NIHSS) according to recovery categories defined by the Fugl-Meyer score.
This scale assesses level of consciousness, extraocular movements, field of vision, facial muscle function, extremity strength, sensory function, coordination (ataxia), language (aphasia), speech (dysarthria) and hemineglect (neglect). Total NIHSS scores range from 0 to 42, with higher values reflecting more severe brain damage. Stroke severity is defined according to threshold scores as follows: > 25 - severe neurological deficits, 5-14 - moderate neurological deficits, < 5 - mild deficits.
Measured: Day 30
Changes in clinical profile in terms of of global impairment
Changes in National Institutes of Health Stroke Scale (NIHSS) according to recovery categories defined by the Fugl-Meyer score.
This scale assesses level of consciousness, extraocular movements, field of vision, facial muscle function, extremity strength, sensory function, coordination (ataxia), language (aphasia), speech (dysarthria) and hemineglect (neglect). Total NIHSS scores range from 0 to 42, with higher values reflecting more severe brain damage. Stroke severity is defined according to threshold scores as follows: > 25 - severe neurological deficits, 5-14 - moderate neurological deficits, < 5 - mild deficits.
Measured: 3 months
Changes in clinical profile in terms of of global impairment
Changes in National Institutes of Health Stroke Scale (NIHSS) according to recovery categories defined by the Fugl-Meyer score.
This scale assesses level of consciousness, extraocular movements, field of vision, facial muscle function, extremity strength, sensory function, coordination (ataxia), language (aphasia), speech (dysarthria) and hemineglect (neglect). Total NIHSS scores range from 0 to 42, with higher values reflecting more severe brain damage. Stroke severity is defined according to threshold scores as follows: > 25 - severe neurological deficits, 5-14 - moderate neurological deficits, < 5 - mild deficits.
Measured: 6 months
Changes in neurological events
Changes in significant clinical worsening defined by a worsening of the NIHSS score by 4 points, epileptic seizure.
This scale assesses level of consciousness, extraocular movements, field of vision, facial muscle function, extremity strength, sensory function, coordination (ataxia), language (aphasia), speech (dysarthria) and hemineglect (neglect). Total NIHSS scores range from 0 to 42, with higher values reflecting more severe brain damage. Stroke severity is defined according to threshold scores as follows: > 25 - severe neurological deficits, 5-14 - moderate neurological deficits, < 5 - mild deficits.
Measured: From enrollment to the end of evaluation at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start1 Sep 2026 (estimated)
- Primary completion1 Mar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain DiseasesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-center, prospective, cohort, interventional study with minimal risks and constraints according to the Loi Jardé (RIPH2). Longitudinal follow-up of patients.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maud GUILLEN, Md, Principal investigator, RENNES CHU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06784518
- Sponsor's protocol ID
- 35RC22_9907-11_SPECTRE
- Other IDs
- 2024-A02034-43
- Acronym
- SPECTRE
- Status last verified
- Mar 2026
- First submitted
- 20 Dec 2024
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke Cerebral Reorganization Pathways Longitudinal Study After Stroke of the Clinical Motor Pattern and the Cerebral Reorganization According to the Different Damaged Motor Pathways (Main and Accessory) (SPECTRE)
- ClinicalTrials.gov ID
- NCT06784518
- Acronym / sponsor ID
- SPECTRE / 35RC22_9907-11_SPECTRE
- Conditions
- Brain Diseases, Ischemic Stroke, Stroke, Brain Infarction, Stroke Rehabilitation
- Keywords
- stroke, Rehabilitation, Upper Limb, Neuroplasticity, Connectivity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 20 Jan 2025 (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.
SPECTRE is a prospective longitudinal study in order to identify whether patients with different degrees of motor recovery are distinguished by distinct brain post-stroke plasticity patterns in the acute and sub-acute phases. This study allows close longitudinal follow-up of patients with severe clinical motor impairment using functional MRI to study cerebral neuroplasticity after ischemic stroke in the acute and sub-acute phase in patients with upper limb motor impairement, taking into account prognostic criteria used in current practice.
Detailed description
Patients are recruited as they are admitted to the neurovascular department. The SAFE score from the Stinear study is taken on Day 3 of the stroke, followed by motor evoked potentials between Day 3-Day 7 of the stroke, for a equal distribution of patients into three prognostic groups according to the PREP2 algorithm (good, limited and poor).
Longitudinal follow-up with clinical scores and functional MRI at Day 7-Day 10, Day 30, Month 3 and Month 6 of stroke.
Patients will ultimately be classified and analyzed according to their effective motor recovery at 6 months, using the Fugl-Meyer score.
The investigators will then conduct a comprehensive analysis of brain connectivity, examining both the anatomical structure of the brain, its functional activity and the dynamic interactions between certain regions of interest over time.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-center, prospective, cohort, interventional study with minimal risks and constraints according to the Loi Jardé (RIPH2). Longitudinal follow-up of patients.
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Other: Clinical scores and functional MRIThree prognostic groups according to the PREP2 algorithm (good, limited and poor). 21 evaluable patients divided into 3 balanced prognostic groups. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Adult (age greater than or equal to 18 years) less than 75 years of age, both sexes;
- single supratentorial ischemic stroke confirmed by brain imaging
- Upper limb deficit defined by a SAFE score <5 (SAFE Stinear protocol, prognosis of post-stroke upper limb recovery) on D3 of stroke. This corresponds to the sum of shoulder abduction and finger extension according to the MRC (Medical Research Council) scale for each of these movements out of 5.
- Absence of comprehension disorders limiting participation;
- Patient covered by french social security;
Key exclusion criteria (2 listed)
- If the prognostic group according to the PREP2 algorithm (good, limited and poor) has already been reached during motor evoked potential assessment the patient is excluded.
- Recurrence of clinically significant stroke (with worsening NIHSS score > 4) during study.
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 |
|---|---|---|
| Clinical scores and functional MRIMotor evoked potentials between Day 3-Day 7 of the stroke, for a equal distribution of patients into three prognostic groups according to the PREP2 algorithm (good, limited and poor). Longitudinal follow-up with clinical scores and functional MRI at Day 7-Day 10, Day 30, Month 3 and Month 6 of stroke. | Other | Patients |
Primary outcome
Changes in effective connectivity of Brain data (fMRI activity and CST tractography)
Time frame: 6 months
Descriptive analysis of topological measures of effective connectivity graphs as a function of effective motor recovery (Fugl-Meyer score - Upper Extremity) at 6 months. The Fugl-Meyer upper limb motor subscale has a maximum score of 66. The effective Fugl Meyer score classifies motor recovery into 3 categories (mild, moderate and severe). A Fugl Meyer score of 0-28 is classified as severe, 29-42 as moderate and 42-66 as mild.
20 secondary outcomes
Changes in Effective connectivity of brain data
Time frame: From Day 7-Day 10 to 6 months
Changes in Structural connectivity of brain data
Time frame: From Day7-Day 10 to 6 months
Changes in Modification of brain activity of brain data
Time frame: From Day 7-Day 10 to 6 months
Changes in Ipsilesional / contralesional laterality index of brain data
Time frame: From Day 7-Day 10 to 6 months
Changes in perfusion of brain data
Time frame: From Day 7-Day 10 to 6 months
Changes in Degree of corticospinal FA ratio of brain data
Time frame: From Day 7-Day 10 to 6 months
Changes in patients' clinical profile in terms of motricity
Time frame: 6 months
Changes in patients' clinical profile in terms of motricity
Time frame: 6 months
Changes in patients' clinical profile in quality of life
Time frame: 6 months
Changes in patients' clinical profile in independence
Time frame: 6 months
Changes in patients' clinical profile in spasticity
Time frame: 6 months
Changes in clinical profile in terms of motor skills
Time frame: Day 7-Day 10
Changes in clinical profile in terms of motor skills
Time frame: Day 30
Changes in clinical profile in terms of motor skills
Time frame: 3 months
Changes in clinical profile in terms of motor skills
Time frame: 6 months
Changes in clinical profile in terms of of global impairment
Time frame: Day 7-Day 10
Changes in clinical profile in terms of of global impairment
Time frame: Day 30
Changes in clinical profile in terms of of global impairment
Time frame: 3 months
Changes in clinical profile in terms of of global impairment
Time frame: 6 months
Changes in neurological events
Time frame: From enrollment to the end of evaluation at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
Maud GUILLEN, Md principal investigator
RENNES CHU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical scores and functional MRI in people with Brain Diseases and Ischemic Stroke, run by Rennes University Hospital 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 18 inclusion and 2 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: opening soon, as of the sponsor's last update on 2 Apr 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maud GUILLEN, Md (299284122 ext. +33, maud.guillen@chu-rennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in effective connectivity of Brain data (fMRI activity and CST tractography) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2026.