Magnetic Brain Stimulation and Computer-based Motor Training for Rehabilitation After Stroke
Repetitive Transcranial Magnetic Stimulation for Enhancing Brain Computer Interphase-induced Plasticity in Stroke: a Crossover Design
2 other identifiers
interventional
24
1 country
1
Brief Summary
The goal of the present clinical trial is to explore whether an innovative technology-based approach can help individuals who have had a stroke and can no longer move their hands with ease. Our approach consists of a combination of two technologies: Transcranial Magnetic Stimulation (TMS) and a Brain-Computer Interface (BCI). The former entails the application of magnetic fields over the head to stimulate the brain preparing it for a better ability to produce movement. The latter consists of measuring brain activity to personalize a type of computer-based training that is designed to increase communication between the brain and the muscles.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2023
CompletedFirst Posted
Study publicly available on registry
November 3, 2023
CompletedStudy Start
First participant enrolled
November 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 19, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 19, 2027
November 9, 2023
October 1, 2023
2.9 years
September 27, 2023
November 8, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Motor-evoked potential (MEP) parameters
An MEP is the electromyography response to a single TMS pulse delivered over the motor cortex, over the representation of multiple muscles. MEP changes will be evaluated with a mixed effects model. mixed-effects model. The model will consider the Patient, Period, Treatment (stimulation type) and Session number. The Period\*Treatment interaction will be verified to detect carry-over effects. The investigators expect to observe a main effect of Treatment and Session number.
Measured two times per day, at the days: 3-12 and 15-24. The first measurement is performed immediately before the rTMS-BCI intervention and the second immediately after the rTMS-BCI intervention.
Fugl-Meyer upper extremity assessment of sensorimotor function
Quantitative evaluation of motor, balance, sensation and joint functions. The sums of values recorded before and after the stimulation periods will be fed into an unpaired sample t-test to evaluate carryover effects whereas the differences observed between recordings before and after the stimulation will be fed into an unpaired sample t-test for the evaluation of initial evidence of the effect of rTMS.
Measured one time at day, at the days: 2, 13, 14, and 25.
Event-related desynchronization (ERD)
Electroencephalography (EEG) will be recorded during a cued motor task. This data will be used to calculate event-related de-synchronization, defined as the difference in signal power in the miu (8-12 Hz) and beta bands (13-30 Hz) between a baseline period prior to the cue and a post-cue period. Changes in ERD will be evaluated with permutation-based statistics.
Measured one time per day, at the days: 2, 13, 14, and 25.
Secondary Outcomes (8)
Brain-Computer Interface accuracy
Measured one time per day, at days 3-12 and days 15-24.
Task-related functional Magnetic Resonance Imaging (t-fMRI)
Measured one time per day, at the days 2, 13, 14, and 25.
Jebsen-Taylor Hand Function Test
Measured one time per day, at the days 2, 13, 14, and 25.
Diffusion-based tractography
Measured one time per day, at the days 2, 13, 14, and 25.
Movement-related cortical potential amplitude
Measured one time per day, at the days 2, 13, 14, and 25.
- +3 more secondary outcomes
Other Outcomes (8)
Adherence
Through study completion, for 25 days.
Upper extremity motor activity log (UE-MAL)
Measured one time per day, at days 2, 13, 14, and 25.
Withdrawal rate
Through study completion, for 25 days.
- +5 more other outcomes
Study Arms (2)
Active stimulation - Placebo stimulation
EXPERIMENTALParticipants 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.
Placebo stimulation - Active stimulation
EXPERIMENTALParticipants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Diagnosis of a subcortical stroke at least 6 months before the initiation of the trial and confirmed with magnetic resonance imaging (MRI) or computed tomography
- Present moderate to severe hemiparesis in an upper limb
- Language comprehension as well as visual and auditory perception sufficient to engage in Brain Computer Interface training
- Age from 20 to 80 years old
- Clear consciousness and stable vital signs
- Eligible for MRI, EEG, BCI and TMS methods
You may not qualify if:
- Drug abuse or recent changes in medications that may alter the central nervous system when the measurements begin or during the measurements (e.g., benzodiazepines, serotoninergic and dopaminergic agents)
- History of seizure
- Bone, joint and muscle diseases
- 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).
- 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
- Lesions in the upper extremities
- Bone, joint and muscle diseases
- Severe spasticity (higher than 3) or pain in the upper limb and affecting wrist extension
- Contraindications of undergoing TMS examinations: history of seizures, history of epilepsy, unclear unconsciousness, migraines or metals on the head
- Contraindications for MRI: metals in the body, metallic prosthetics or claustrophobia
- Participation in other interventional trials using BCI or rTMS within less than 6 months ago
- Participation in another interventional clinical trial
- Suspected lack of compliance
- Pregnant or nursing women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Max Planck Institute for Human Cognitive and Brain Sciences
Leipzig, Saxony, 04103, Germany
Related Publications (2)
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.
PMID: 35795793BACKGROUNDPeng 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.
PMID: 35422693BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Aimee Flores-Sandoval, MsC
Charité Universitätmedizin Berlin and Max Planck Institute for Human Cognitive and Brain Sciences
- STUDY DIRECTOR
Arno Villringer, MD PhD
Max Planck Institute for Human Cognitive and Brain Sciences
- PRINCIPAL INVESTIGATOR
Bernhard Sehm, PD. med.
Max Planck Institute for Human Cognitive and Brain Sciences and Halle University
- PRINCIPAL INVESTIGATOR
Vadim Nikulin, PhD.
Max Planck Institute for Human Cognitive and Brain Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2023
First Posted
November 3, 2023
Study Start
November 8, 2023
Primary Completion (Estimated)
September 19, 2026
Study Completion (Estimated)
September 19, 2027
Last Updated
November 9, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
- Time Frame
- After the end of the study and for 10 years
- Access Criteria
- The purpose for requesting the data and planned analysis must comply with the General Data Protection Regulation as well as Medical device regulation of the European Union.
Data sharing will require approval by the local ethics committee (EC) of the researcher requesting the data along with public registration of the study. Data sharing will also be subject to compliance with the European Union General Data Protection Regulation.