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NCT Number: NCT06951035

Impact of rTMS on BCI Control in Upper Limb Motor Rehabilitation of Patients With Chronic Stroke

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.

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).

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

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)

Primary outcomes

  1. 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.

Secondary outcomes

  1. Measuring secondary BCI performance by using the sensitivity indicator " recall "

    Time frame: Up to 20 weeks

    Sensitivity is the proportion of correct IM task detections out of all real IM tasks

  2. Measuring secondary BCI performance by using the positive predictive value " precision "

    Time frame: Up to 20 weeks

    The positive predictive value is the proportion of correct MI detections out of all tasks detected by algorithm

  3. Measuring secondary BCI performance by using the Run-Wise Cross-Validation method

    Time frame: Up to 20 weeks

    To reduce the the intersessional variabilityy in accurnc, we use the Run-Wise Cross-Validation (RWCV CA) method will be used.

  4. Assessment of the motor function using the Fugl-Meyer upper limb motor subscale (UE-FMA)

    Time frame: Inclusion visit, 6 weeks

    Rough assessment of dexterity during goal directed movements

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

    Time frame: Up to 20 weeks

    Rough assessment of dexterity during goal directed movements

  6. Assessment of the motor function using the Grip and Pinch force

    Time frame: Up to 20 weeks

    Pure evaluation of the finger flexion force using dynamometer

  7. Evaluation of spasticity

    Time frame: Inclusion visit, 6 weeks

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

  8. Hemineglet assessment by text reading test

    Time frame: Up to 20 weeks

    A text reading test in which the number of words correctly read in one minute and the percentage of words omitted will be counted

  9. Hemineglet assessment by line bissection test

    Time frame: Up to 20 weeks

    The measurement of the center deviation will be quantified

  10. Analysis of spectral power

    Time frame: Up to 20 weeks

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

  11. Phase-Amplitude Coupling (PAC) analysis

    Time frame: Up to 20 weeks

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

  12. Quantification of the functional connectivity (FC)

    Time frame: 2 minutes before starting rTMS stimulation

    To quantify this communication, we will use a correlation matrix constructed by calculating the coefficients of spectral coherence between all of EEG channels pairs

  13. Measurement of cortical excitability (Motor Evoked Potentials)

    Time frame: Inclusion visit, 6 weeks, 18 weeks

    Assessment of the amplitude of MEPs per single shock TMS and representes the therapeutic target of rTMS

Study contacts

Contact information is provided by the study sponsor or research team.

Paolo BARTOLOMEO, MD, INSERM DR2

CONTACT

[email protected]

+33 1 57 27 41 40

Sponsors and collaborators

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Other Gov

Registry information

Official study 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

Acronym: BCINET

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Apr 30, 2025
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.