Magnetic Brain Stimulation and Computer-based Motor Training for Rehabilitation After Stroke
NCT ID: NCT06116942
Last Updated: 2023-11-09
Study Results
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Basic Information
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RECRUITING
NA
24 participants
INTERVENTIONAL
2023-11-08
2027-09-19
Brief Summary
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Detailed Description
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1. to provide preliminary evidence of the effect of rTMS (repetitive Transcranial Magnetic Stimulation) on brain-computer interface (BCI)-mediated plasticity on individuals with hemiparesis after stroke
2. Measure adherence and withdrawal rates of the present protocol for informing a future large-scale randomized controlled trial
The active stimulation (rTMS) consists of an intermittent theta burst (iTBS) protocol whereas the placebo condition encompasses rTMS stimulation delivered with a Sham coil (Sham).
Procedures:
The study will entail 25 sessions. The study is composed of six different types of sessions in a crossover design:
1. Screening session (day 1): Includes the informed consent form signature, enrollment and BCI calibration
2. Before-treatment and after-treatment sessions (day 2, 13, 14 and 25) include the recording of EEG and MRI data, as well as the application of tests and questionnaires for evaluation of motor function
3. Daily visit with blood draw sessions (days 3, 12, 15 and 24): consist of the delivery of active or sham rTMS followed by BCI training preceded and followed by a blood draw.
4. Daily visit sessions without a blood draw (days 4 to 11 and 16 to 23): consist of the delivery of active or sham rTMS followed by BCI training.
After a screening session (day 1), the clinical study begins. The period I of the study begins with a before-treatment session (day 2). Then, the intervention (rTMS or sham followed by BCI training) is delivered during 10 daily visits over a 2-week period excluding weekends (days 3 to 12). Within the daily visits, there are 2 daily visits with blood draws (days 3 and 12) and the rest do not include any blood draws (days 4 to 11). Then, an after-treatment session takes place (day 13).
After period I, a washout period of 4 weeks takes place. No measurements or training are required during this time. In Period II of the study, the session flow is repeated except for the screening session. Therefore, period II includes a before-treatment session (day 14), 10 daily visits (days 15 to 24), with 2 daily visits that include blood draws (days 15 and 24), and an after-treatment session (day 25).
Research questions:
1. Does rTMS promote better motor recovery after BCI training in comparison to sham?
2. Can rTMS propitiate stronger effects on neural physiology after BCI training in comparison with sham?
3. Is there an association between behavioral and physiological changes after the proposed intervention?
4. What is the adherence and withdrawal rate and reason for withdrawal of the proposed study design and procedures?
5. Is there an association between brain structures associated with motor function at baseline and the changes observed after rTMS?
6. Can applying rTMS have a better effect on self-perceived motor performance in daily activities in comparison to Sham?
7. Are serum molecular markers of plasticity and neural turnover modulated by rTMS?
Hypotheses:
1. A higher increase in motor performance will be observed after the rTMS-BCI in comparison with sham-BCI. The motor performance will be assessed as Fugl-Meyer Assessment for upper extremity score as the primary outcome measure; and as the Jebsen Taylor hand function test and BCI accuracy as the secondary outcome measures
2. Higher physiological changes will be observed after rTMS-BCI in comparison with sham-BCI. The electrophysiological changes will be assessed as Motor evoked potentials, as primary outcome measured; and as motor-related cortical potentials, Event-Related Desynchronization and functionalMagnetic Resonance Imaging changes as secondary outcome measures
3. Behavioral and physiological changes will be associated
4. Changes in structural MRI will be associated with behavioral outcome measures after rTMS-BCI and sham-BCI. Structural MRI will be assessed as Fractional Anisotropy changes, as a primary outcome measure; and voxel-based morphometry as a secondary outcome measure
5. Individuals will have a higher perceived improvement in activities of daily living, measured as higher scores in the Upper extremity motor activity log (UE-MAL) and the first and last items of the Stroke impact scale (SIS) questionnaire after rTMS-BCI in comparison with sham-BCI
6. The increase in Brain-Derived Neurotrophic Factor (BDNF) will be higher after rTMS-BCI in comparison with after sham-BCI and an association between BDNF levels and behavioral markers of motor recovery will exist
As an exploratory analysis, the investigators will inspect preliminary evidence of the effects of the stimulation by verifying changes in serological markers of neuronal plasticity and turnover.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Active stimulation - Placebo stimulation
Participants will undergo a 2 intervention periods. The first intervention period will consist of a 2-week course of rTMS followed by BCI-mediated training. This intervention will be succeeded by a 4-week washout period to mitigate any carry-over effects. The second intervention period will entail 2 weeks of sham rTMS followed by BCI-mediated training.
Active rTMS
The Transcranial Magnetic Stimulation will consist of placing a figure-of-eight shape coil of wire over the head of the participants. Then, a brief electric current will pass through the coil, inducing a magnetic field capable of stimulating neurons located beneath the coil. For the active coil, the maximal stimulation intensity is reached beneath the center of the coil.
In the present study, the intermittent theta-burst protocol will be implemented. This protocol is expected to modulate the excitability of the brain, priming it for a stronger activation of the motor-related brain areas engaged during brain-computer interface-based training. The structural MRI of each participant will be used to guide neuronavigation towards ipsilesional motor areas.
Sham rTMS
To implement a placebo stimulation, a sham coil will be used to deliver the same stimulation protocol. The sham coil is identical in dimensions and weight to the active coil but produces a diminished magnetic field. For the sham coil, the stimulation intensity is minimal beneath the center of the coil, the same area with the highest intensity during stimulation with an active coil. The structural MRI scan of each participant will be used to guide neuronavigation towards the same area where the active stimulation was applied.
Placebo stimulation - Active stimulation
Participants will undergo the same interventions as the first arm but delivered in inverse order. The first intervention period will consist of 2 weeks of sham rTMS followed by BCI-mediated training. The second intervention period will entail 2 weeks of rTMS prior to BCI-mediated training and will start after a 4-weeks washout period.
Active rTMS
The Transcranial Magnetic Stimulation will consist of placing a figure-of-eight shape coil of wire over the head of the participants. Then, a brief electric current will pass through the coil, inducing a magnetic field capable of stimulating neurons located beneath the coil. For the active coil, the maximal stimulation intensity is reached beneath the center of the coil.
In the present study, the intermittent theta-burst protocol will be implemented. This protocol is expected to modulate the excitability of the brain, priming it for a stronger activation of the motor-related brain areas engaged during brain-computer interface-based training. The structural MRI of each participant will be used to guide neuronavigation towards ipsilesional motor areas.
Sham rTMS
To implement a placebo stimulation, a sham coil will be used to deliver the same stimulation protocol. The sham coil is identical in dimensions and weight to the active coil but produces a diminished magnetic field. For the sham coil, the stimulation intensity is minimal beneath the center of the coil, the same area with the highest intensity during stimulation with an active coil. The structural MRI scan of each participant will be used to guide neuronavigation towards the same area where the active stimulation was applied.
Interventions
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Active rTMS
The Transcranial Magnetic Stimulation will consist of placing a figure-of-eight shape coil of wire over the head of the participants. Then, a brief electric current will pass through the coil, inducing a magnetic field capable of stimulating neurons located beneath the coil. For the active coil, the maximal stimulation intensity is reached beneath the center of the coil.
In the present study, the intermittent theta-burst protocol will be implemented. This protocol is expected to modulate the excitability of the brain, priming it for a stronger activation of the motor-related brain areas engaged during brain-computer interface-based training. The structural MRI of each participant will be used to guide neuronavigation towards ipsilesional motor areas.
Sham rTMS
To implement a placebo stimulation, a sham coil will be used to deliver the same stimulation protocol. The sham coil is identical in dimensions and weight to the active coil but produces a diminished magnetic field. For the sham coil, the stimulation intensity is minimal beneath the center of the coil, the same area with the highest intensity during stimulation with an active coil. The structural MRI scan of each participant will be used to guide neuronavigation towards the same area where the active stimulation was applied.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Present moderate to severe hemiparesis in an upper limb
3. Language comprehension as well as visual and auditory perception sufficient to engage in Brain Computer Interface training
4. Age from 20 to 80 years old
5. Clear consciousness and stable vital signs
6. Eligible for MRI, EEG, BCI and TMS methods
Exclusion Criteria
2. History of seizure
3. Bone, joint and muscle diseases
4. Peripheral neuropathy or other neurological or psychiatric diseases (including, tinnitus, migraine, or mood disorders with the exception of minimal, mild, and moderate depression, reflected as a Beck depression scale score lower than 29).
5. Strong cognitive deficits (including speech, attention, hearing, vision, sensation or intelligence deficits) reflected as a Montreal Cognitive Assessment (MoCA) score lower or equal to 24
6. Lesions in the upper extremities
7. Bone, joint and muscle diseases
8. Severe spasticity (higher than 3) or pain in the upper limb and affecting wrist extension
9. Contraindications of undergoing TMS examinations: history of seizures, history of epilepsy, unclear unconsciousness, migraines or metals on the head
10. Contraindications for MRI: metals in the body, metallic prosthetics or claustrophobia
11. Participation in other interventional trials using BCI or rTMS within less than 6 months ago
12. Participation in another interventional clinical trial
13. Suspected lack of compliance
14. Pregnant or nursing women
20 Years
80 Years
ALL
No
Sponsors
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University of Halle Medical Faculty
OTHER
Max Planck Institute for Human Cognitive and Brain Sciences
OTHER
Responsible Party
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Principal Investigators
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Aimee Flores-Sandoval, MsC
Role: STUDY_CHAIR
Charité Universitätmedizin Berlin and Max Planck Institute for Human Cognitive and Brain Sciences
Arno Villringer, MD PhD
Role: STUDY_DIRECTOR
Max Planck Institute for Human Cognitive and Brain Sciences
Bernhard Sehm, PD. med.
Role: PRINCIPAL_INVESTIGATOR
Max Planck Institute for Human Cognitive and Brain Sciences and Halle University
Vadim Nikulin, PhD.
Role: PRINCIPAL_INVESTIGATOR
Max Planck Institute for Human Cognitive and Brain Sciences
Locations
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Max Planck Institute for Human Cognitive and Brain Sciences
Leipzig, Saxony, Germany
Countries
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Central Contacts
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References
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Tang Z, Han K, Wang R, Zhang Y, Zhang H. Excitatory Repetitive Transcranial Magnetic Stimulation Over the Ipsilesional Hemisphere for Upper Limb Motor Function After Stroke: A Systematic Review and Meta-Analysis. Front Neurol. 2022 Jun 20;13:918597. doi: 10.3389/fneur.2022.918597. eCollection 2022.
Peng Y, Wang J, Liu Z, Zhong L, Wen X, Wang P, Gong X, Liu H. The Application of Brain-Computer Interface in Upper Limb Dysfunction After Stroke: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Front Hum Neurosci. 2022 Mar 29;16:798883. doi: 10.3389/fnhum.2022.798883. eCollection 2022.
Related Links
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Other Identifiers
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DE-23-00014797
Identifier Type: REGISTRY
Identifier Source: secondary_id
Neurotech Stroke
Identifier Type: -
Identifier Source: org_study_id
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