Chonic Stroke Patients With Motor Impairment of Upper LimbBCINETNCT06951035
Impact of rTMS on BCI Control in Upper Limb Motor Rehabilitation of Patients With Chronic Stroke
A study testing Repetitive transcranial magnetic stimulation (rTMS) in people with Chonic Stroke Patients With Motor Impairment of Upper Limb, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
Cerebrovascular accidents (strokes) are a major public health issue. Stroke is the 3rd leading cause of death and the leading cause of disability and loss of autonomy. In France, there are currently 130,000 new cases per year, and the aging of the population will lead to an increase in this number over the next few… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chonic Stroke Patients With Motor Impairment of Upper Limb
- What is being tested?
- Repetitive transcranial magnetic stimulation (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 25 Apr 2025to Apr 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Single Stroke older than 6 months
- Distal motor deficit of the upper limb (UE-FMA score < 53) with visible extension of the fingers (Medical Research Council (mRC) score ≥ 2)
- Right-handed
- Between 18 and 85 years of age
- Having given their written consent
Who cannot join
- Patient under tutorship or guardianship, under safeguard of justice, deprived of liberty, pregnant or breast feeding women
- Life-threatening pathologies or compromising follow-up during the study period
- Trouble of understanding : score below 12/15 in the Boston Diagnostic Aphasia Examination (BDAE) order execution test
- Fixed spasticity of finger or carpal flexors (mAS score = 4) or botulinum toxin injection less than 12 weeks old in the forearm or hand
- History of degenarative neurological pathology or craniectomy
- Deficient upper limb skin lesion preventing use of mucle stimulation
Show all 10Show fewer
- Skin lesion of the scalp preventing EEG placement
- Participation in biomedical therapeutic research that may affect the recovery of the deficient hand during the study
- Patient who has previously participated in a therapeutic study rTMS (excluding single shock) or a BCI
- Patient who does not wish to be informed of a brain abnormality discovered accidentally on MRI
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, 1 recruiting
- Recruiting
Institut du Cerveau
Paris, 75013
Paolo BARTOLOMEO, MD, INSERM DR2, +33 1 57 27 41 40, paolo.bartolomeo@upmc.fr
About this study
Official title: ETUDE DE L'AMELIORATION DU CONTROLE DES INTERFACES CERVEAU-MACHINE PAR LA CONNECTIVITE FONCTIONNELLE ET LA STIMULATION MAGNETIQUE TRANSCRANIENNE REPETEE DANS LA REEDUCATION MOTRICE DU MEMBRE SUPERIEUR APRES UN ACCIDENT VASCULAIRE CHRONIQUE
Cerebrovascular accidents (strokes) are a major public health issue. Stroke is the 3rd leading cause of death and the leading cause of disability and loss of autonomy. In France, there are currently 130,000 new cases per year, and the aging of the population will lead to an increase in this number over the next few years. Among post-stroke impairments, motor deficit of the upper limb is the most common disability, affecting 73-88% of first-time stroke patients and 55-75% of chronic patients. Associated deficits can complicate rehabilitation management and affect recovery. The clinical profile of patients with motor deficits is therefore varied and complex, requiring an individualized approach. At present, only physiotherapy is recommended, with modest results.
Repeated transcranial magnetic stimulation is a therapy that can improve motor recovery, but currently has a low level of evidence according to the HAS (French Hight Health Authority), notably because of variability in efficacy due to heterogeneity in the clinical profile of patients. Nevertheless, it is still recommended for the recovery of cognitive functions, but also for resistant depression, and could be used to stimulate motor imagery (MI). MI training also has the advantage of stimulating the motor network. Difficult to achieve for a number of patients, the use of rTMS could facilitate this cognitive task and, in particular, provide better access to brain-computer interfaces (BCI). Indeed, among the innovative rehabilitation therapies, BCIs have emerged as the most promising. By translating brain activity during a cognitive task into a command such as electrical muscle stimulation, BCIs would restore the damaged motor network and induce motor recovery. The main obstacle to their widespread use in clinical practice is their lack of reliability, as almost 30% of patients are unable to control them correctly, either because of difficulty in performing the MI task, or because of difficulty in identifying a universal brain signature.
Read more
The BCINET project aims to improve the reliability of BCIs in two ways: by improving detection of the motor imagination task using new brain signatures, and through cognitive facilitation using rTMS.
- - Using the dynamic communication of different brain areas during the MI task (or functional connectivity), we can identify patient-specific signatures. Studies of functional connectivity in healthy subjects performing an MI task without associated BCI have shown the interest of certain measures such as node degree or clustering coefficient. To find out whether functional connectivity parameters can be used in BCI algorithms, we will evaluate their effectiveness on an initial group of 5 patients to define their performance in discriminating the MI task and to determine their evolution over time in the absence of brain stimulation in stroke patients. Their initial study will also enable us to identify their evolution when TMS stimulation is applied.
- - Cerebral magnetic stimulation could facilitate the MI task and enable better BCI rehabilitation for a number of patients. Two studies using either an inhibitory or excitatory stimulation protocol showed an improvement in spectral power signal and better discrimination of the MI task. However, the results were acquired using a single pre- and post-therapy measurement, and did not take into account behavioral variability in the use of BCIs or variability in TMS response according to patient profile. Therefore, in order to identify whether rTMS would improve BCI control, we would perform 9 Single-Case Experimental Design (SCED) studies in multiple baselines on a group of 5 patients according to 3 clinical profiles and 3 rTMS stimulation strategies. SCEDs are suitable experimental models for heterogeneous populations, particularly when the intervention presents some inter-individual variability in efficacy. They have the advantage of being able to demonstrate, on an individual scale, the effectiveness of the intervention on a small group of patients. Replication of the SCED allows us to increase the external validity of the intervention on sub-groups of patients (clinical severity, presence of associated hemineglect) and to study modifications in the interventional strategy (stimulation frequency, stimulation site).
- Being tested
- Repetitive transcranial magnetic stimulation (rTMS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive transcranial magnetic stimulation (rTMS)Device
The repeated stimulations will be carried out using an eight-part probe detected by the infrared camera ("eight shaped tracked coil"), connected to a Rapid 2 stimulator (Magstim Company, Whitland, UK). The stimulation will be performed manually or with robotic assistance using TMS-Robot (Axilum Robotics, SCHILTIGHEIM, France)
| Study group | Role | What they receive |
|---|---|---|
| rTMS-free group | No intervention | Chronic stroke patients with motor deficit of upper limb |
| Contralesional Inhibitory stimulation of the M1 cortex. | Experimental | The probe will be placed on the healthy motor cortex at the Extensor Carpi Radialis " hotspot " level.
Performed on 15 participants (5 participants per group)
* Group A : chronic stroke with severe upper limb motor deficit (UE-FMA score ≤ 31)
* Group B : chronic stroke with mild upper limb motor deficit (UE-FMA score > 31)
* Group C : chronic stroke with upper limb motor deficit with hemineglect Receives: Device: Repetitive transcranial magnetic stimulation (rTMS) |
| Ipsilesional excitatory stimulation of the M1 cortex. | Experimental | The probe will be placed on the injured motor cortex at the Extensor Carpi Radialis " hotspot " level.
Performed on 15 participants (5 participants per group)
* Group A : chronic stroke with severe upper limb motor deficit (UE-FMA score ≤ 31)
* Group B : chronic stroke with mild upper limb motor deficit (UE-FMA score > 31)
* Group C : chronic stroke with upper limb motor deficit with hemineglect Receives: Device: Repetitive transcranial magnetic stimulation (rTMS) |
| Personalized exitatory stimulation according to structural connectivity. | Experimental | The probe will be placed at the stimulation site identified by control theory. Performed on 15 participants (5 participants per group)
* Group A : chronic stroke with severe upper limb motor deficit (UE-FMA score ≤ 31)
* Group B : chronic stroke with mild upper limb motor deficit (UE-FMA score > 31)
* Group C : chronic stroke with upper limb motor deficit with hemineglect Receives: Device: Repetitive transcranial magnetic stimulation (rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring primary BCI performance
Accuracy was choosen, which correspond to the percentage of correct detection of mental tasks (either MI or rest) on all tasks performed during the session.
Measured: 6 weeks, 18 weeks
Secondary outcomes (13)
Measuring secondary BCI performance by using the sensitivity indicator " recall "
Sensitivity is the proportion of correct IM task detections out of all real IM tasks
Measured: Up to 20 weeks
Measuring secondary BCI performance by using the positive predictive value " precision "
The positive predictive value is the proportion of correct MI detections out of all tasks detected by algorithm
Measured: Up to 20 weeks
Measuring secondary BCI performance by using the Run-Wise Cross-Validation method
To reduce the the intersessional variabilityy in accurnc, we use the Run-Wise Cross-Validation (RWCV CA) method will be used.
Measured: Up to 20 weeks
Assessment of the motor function using the Fugl-Meyer upper limb motor subscale (UE-FMA)
Rough assessment of dexterity during goal directed movements
Measured: Inclusion visit, 6 weeks
Assessment of the motor function using Box and Block Test (BBT)
Rough assessment of dexterity during goal directed movements
Measured: Up to 20 weeks
Assessment of the motor function using the Grip and Pinch force
Pure evaluation of the finger flexion force using dynamometer
Measured: Up to 20 weeks
Evaluation of spasticity
Will be assessed and monitored using the modified Ashworth scale (mAs score)
Measured: Inclusion visit, 6 weeks
Hemineglet assessment by text reading test
A text reading test in which the number of words correctly read in one minute and the percentage of words omitted will be counted
Measured: Up to 20 weeks
Hemineglet assessment by line bissection test
The measurement of the center deviation will be quantified
Measured: Up to 20 weeks
Analysis of spectral power
Measurement of the power of electrical signal produced by the brain depending on frequency
Measured: Up to 20 weeks
Phase-Amplitude Coupling (PAC) analysis
By analysing the phase-amplitude relationships of different frequency bands in the EEG signal
Measured: Up to 20 weeks
Quantification of the functional connectivity (FC)
To quantify this communication, we will use a correlation matrix constructed by calculating the coefficients of spectral coherence between all of EEG channels pairs
Measured: 2 minutes before starting rTMS stimulation
Measurement of cortical excitability (Motor Evoked Potentials)
Assessment of the amplitude of MEPs per single shock TMS and representes the therapeutic target of rTMS
Measured: Inclusion visit, 6 weeks, 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start25 Apr 2025
- Primary completionApr 2028 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chonic Stroke Patients With Motor Impairment of Upper LimbStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised Mutliple Baseline SCED.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06951035
- Sponsor's protocol ID
- C23-46
- Other IDs
- 2024-A00230- 47
- Acronym
- BCINET
- Status last verified
- Jun 2026
- First submitted
- 15 Apr 2025
- Last updated
- 5 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ETUDE DE L'AMELIORATION DU CONTROLE DES INTERFACES CERVEAU-MACHINE PAR LA CONNECTIVITE FONCTIONNELLE ET LA STIMULATION MAGNETIQUE TRANSCRANIENNE REPETEE DANS LA REEDUCATION MOTRICE DU MEMBRE SUPERIEUR APRES UN ACCIDENT VASCULAIRE CHRONIQUE
- ClinicalTrials.gov ID
- NCT06951035
- Acronym / sponsor ID
- BCINET / C23-46
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 25 Apr 2025 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 30 Apr 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.
Cerebrovascular accidents (strokes) are a major public health issue. Stroke is the 3rd leading cause of death and the leading cause of disability and loss of autonomy. In France, there are currently 130,000 new cases per year, and the aging of the population will lead to an increase in this number over the next few years. Among post-stroke impairments, motor deficit of the upper limb is the most common disability, affecting 73-88% of first-time stroke patients and 55-75% of chronic patients. Associated deficits can complicate rehabilitation management and affect recovery. The clinical profile of patients with motor deficits is therefore varied and complex, requiring an individualized approach. At present, only physiotherapy is recommended, with modest results.
Repeated transcranial magnetic stimulation is a therapy that can improve motor recovery, but currently has a low level of evidence according to the HAS (French Hight Health Authority), notably because of variability in efficacy due to heterogeneity in the clinical profile of patients. Nevertheless, it is still recommended for the recovery of cognitive functions, but also for resistant depression, and could be used to stimulate motor imagery (MI). MI training also has the advantage of stimulating the motor network. Difficult to achieve for a number of patients, the use of rTMS could facilitate this cognitive task and, in particular, provide better access to brain-computer interfaces (BCI). Indeed, among the innovative rehabilitation therapies, BCIs have emerged as the most promising. By translating brain activity during a cognitive task into a command such as electrical muscle stimulation, BCIs would restore the damaged motor network and induce motor recovery. The main obstacle to their widespread use in clinical practice is their lack of reliability, as almost 30% of patients are unable to control them correctly, either because of difficulty in performing the MI task, or because of difficulty in identifying a universal brain signature.
The BCINET project aims to improve the reliability of BCIs in two ways: by improving detection of the motor imagination task using new brain signatures, and through cognitive facilitation using rTMS.
- - Using the dynamic communication of different brain areas during the MI task (or functional connectivity), we can identify patient-specific signatures. Studies of functional connectivity in healthy subjects performing an MI task without associated BCI have shown the interest of certain measures such as node degree or clustering coefficient. To find out whether functional connectivity parameters can be used in BCI algorithms, we will evaluate their effectiveness on an initial group of 5 patients to define their performance in discriminating the MI task and to determine their evolution over time in the absence of brain stimulation in stroke patients. Their initial study will also enable us to identify their evolution when TMS stimulation is applied.
- - Cerebral magnetic stimulation could facilitate the MI task and enable better BCI rehabilitation for a number of patients. Two studies using either an inhibitory or excitatory stimulation protocol showed an improvement in spectral power signal and better discrimination of the MI task. However, the results were acquired using a single pre- and post-therapy measurement, and did not take into account behavioral variability in the use of BCIs or variability in TMS response according to patient profile. Therefore, in order to identify whether rTMS would improve BCI control, we would perform 9 Single-Case Experimental Design (SCED) studies in multiple baselines on a group of 5 patients according to 3 clinical profiles and 3 rTMS stimulation strategies. SCEDs are suitable experimental models for heterogeneous populations, particularly when the intervention presents some inter-individual variability in efficacy. They have the advantage of being able to demonstrate, on an individual scale, the effectiveness of the intervention on a small group of patients. Replication of the SCED allows us to increase the external validity of the intervention on sub-groups of patients (clinical severity, presence of associated hemineglect) and to study modifications in the interventional strategy (stimulation frequency, stimulation site).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomised Mutliple Baseline SCED.
| Arm | Type | Receives |
|---|---|---|
| rTMS-free group | No intervention | –Chronic stroke patients with motor deficit of upper limb |
| Contralesional Inhibitory stimulation of the M1 cortex. | Experimental | Device: Repetitive transcranial magnetic stimulation (rTMS)The probe will be placed on the healthy motor cortex at the Extensor Carpi Radialis " hotspot " level. Performed on 15 participants (5 participants per group) * Group A : chronic stroke with severe upper limb motor deficit (UE-FMA score ≤ 31) * Group B : chronic stroke with mild upper limb motor deficit (UE-FMA score > 31) * Group C : chronic stroke with upper limb motor deficit with hemineglect |
| Ipsilesional excitatory stimulation of the M1 cortex. | Experimental | Device: Repetitive transcranial magnetic stimulation (rTMS)The probe will be placed on the injured motor cortex at the Extensor Carpi Radialis " hotspot " level. Performed on 15 participants (5 participants per group) * Group A : chronic stroke with severe upper limb motor deficit (UE-FMA score ≤ 31) * Group B : chronic stroke with mild upper limb motor deficit (UE-FMA score > 31) * Group C : chronic stroke with upper limb motor deficit with hemineglect |
| Personalized exitatory stimulation according to structural connectivity. | Experimental | Device: Repetitive transcranial magnetic stimulation (rTMS)The probe will be placed at the stimulation site identified by control theory. Performed on 15 participants (5 participants per group) * Group A : chronic stroke with severe upper limb motor deficit (UE-FMA score ≤ 31) * Group B : chronic stroke with mild upper limb motor deficit (UE-FMA score > 31) * Group C : chronic stroke with upper limb motor deficit with hemineglect |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Single Stroke older than 6 months
- Distal motor deficit of the upper limb (UE-FMA score < 53) with visible extension of the fingers (Medical Research Council (mRC) score ≥ 2)
- Right-handed
- Between 18 and 85 years of age
- Having given their written consent
Key exclusion criteria (10 listed)
- Patient under tutorship or guardianship, under safeguard of justice, deprived of liberty, pregnant or breast feeding women
- Life-threatening pathologies or compromising follow-up during the study period
- Trouble of understanding : score below 12/15 in the Boston Diagnostic Aphasia Examination (BDAE) order execution test
- Fixed spasticity of finger or carpal flexors (mAS score = 4) or botulinum toxin injection less than 12 weeks old in the forearm or hand
- History of degenarative neurological pathology or craniectomy
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 |
|---|---|---|
| Repetitive transcranial magnetic stimulation (rTMS)The repeated stimulations will be carried out using an eight-part probe detected by the infrared camera ("eight shaped tracked coil"), connected to a Rapid 2 stimulator (Magstim Company, Whitland, UK). The stimulation will be performed manually or with robotic assistance using TMS-Robot (Axilum Robotics, SCHILTIGHEIM, France) | Device | Contralesional Inhibitory stimulation of the M1 cortex., Ipsilesional excitatory stimulation of the M1 cortex., Personalized exitatory stimulation according to structural connectivity. |
Primary outcome
Measuring primary BCI performance
Time frame: 6 weeks, 18 weeks
Accuracy was choosen, which correspond to the percentage of correct detection of mental tasks (either MI or rest) on all tasks performed during the session.
13 secondary outcomes
Measuring secondary BCI performance by using the sensitivity indicator " recall "
Time frame: Up to 20 weeks
Measuring secondary BCI performance by using the positive predictive value " precision "
Time frame: Up to 20 weeks
Measuring secondary BCI performance by using the Run-Wise Cross-Validation method
Time frame: Up to 20 weeks
Assessment of the motor function using the Fugl-Meyer upper limb motor subscale (UE-FMA)
Time frame: Inclusion visit, 6 weeks
Assessment of the motor function using Box and Block Test (BBT)
Time frame: Up to 20 weeks
Assessment of the motor function using the Grip and Pinch force
Time frame: Up to 20 weeks
Evaluation of spasticity
Time frame: Inclusion visit, 6 weeks
Hemineglet assessment by text reading test
Time frame: Up to 20 weeks
Hemineglet assessment by line bissection test
Time frame: Up to 20 weeks
Analysis of spectral power
Time frame: Up to 20 weeks
Phase-Amplitude Coupling (PAC) analysis
Time frame: Up to 20 weeks
Quantification of the functional connectivity (FC)
Time frame: 2 minutes before starting rTMS stimulation
Measurement of cortical excitability (Motor Evoked Potentials)
Time frame: Inclusion visit, 6 weeks, 18 weeks
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 5 Jun 2026.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive transcranial magnetic stimulation (rTMS) in people with Chonic Stroke Patients With Motor Impairment of Upper Limb, run by Institut National de la Santé Et de la Recherche Médicale, France 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 5 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 5 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?
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 Paolo BARTOLOMEO, MD, INSERM DR2 (+33 1 57 27 41 40, paolo.bartolomeo@upmc.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring primary BCI performance (time frame: 6 weeks, 18 weeks). 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 5 Jun 2026.