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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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.

Paolo BARTOLOMEO, MD, INSERM DR2 contact

+33 1 57 27 41 40

paolo.bartolomeo@upmc.fr

France1 site, 1 recruiting
  • Institut du Cerveau

    Paris, 75013

    Paolo BARTOLOMEO, MD, INSERM DR2, +33 1 57 27 41 40, paolo.bartolomeo@upmc.fr

    Recruiting

Other trials in France

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.

  1. - 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.
  2. - 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 groups in NCT06951035
Study groupRoleWhat they receive
rTMS-free groupNo interventionChronic stroke patients with motor deficit of upper limb
Contralesional Inhibitory stimulation of the M1 cortex.ExperimentalThe 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.ExperimentalThe 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.ExperimentalThe 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. Assessment of the motor function using Box and Block Test (BBT)

    Rough assessment of dexterity during goal directed movements

    Measured: Up to 20 weeks

  6. 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

  7. Evaluation of spasticity

    Will be assessed and monitored using the modified Ashworth scale (mAs score)

    Measured: Inclusion visit, 6 weeks

  8. 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

  9. Hemineglet assessment by line bissection test

    The measurement of the center deviation will be quantified

    Measured: Up to 20 weeks

  10. Analysis of spectral power

    Measurement of the power of electrical signal produced by the brain depending on frequency

    Measured: Up to 20 weeks

  11. Phase-Amplitude Coupling (PAC) analysis

    By analysing the phase-amplitude relationships of different frequency bands in the EEG signal

    Measured: Up to 20 weeks

  12. 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

  13. 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.

  1. First posted30 Apr 2025
  2. Study start25 Apr 2025
  3. Primary completionApr 2028 (estimated)
  4. Study completionApr 2029 (estimated)

Resources

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)
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

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.

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