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The purpose of this study is to investigate the immediate effects of non-invasive temporal interference stimulation (TIS) targeting the striatum on sentence processing and brain connectivity in patients with neurodegenerative diseases.
The study aims to investigate the immediate effects of non-invasive temporal interference stimulation (TIS) targeting the deep structures of the fronto-striatal circuit involved in language processing. The research focuses on patients with neurodegenerative diseases who often suffer from communication deficits and impaired sentence comprehension.
Participants will undergo a cross-over design consisting of a single session of active TIS directed at the striatum and a session of placebo stimulation. The stimulation will be administered in a randomized order. The duration of the stimulation is approximately 20 minutes. During the stimulation, participants will perform a sentence comprehension task. Resting-state fMRI measurements will be taken before and after the stimulation to evaluate offline effects on brain connectivity and potential neuroplasticity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active TIS followed by Placebo TIS | Experimental | Participants first receive single-session active TIS targeting the striatum for approx. 20 minutes. Following a washout period, they receive placebo (sham) TIS. |
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| Placebo TIS followed by Active TIS | Experimental | Participants first receive single-session placebo (sham) TIS for approx. 20 minutes. Following a washout period, they receive active TIS targeting the striatum. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Temporal Interference Stimulation (TIS) | Device | Non-invasive brain interference stimulation applied for approximately 20 minutes while the participant performs a sentence comprehension task. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Task-Related Brain Activation | Assessment of the immediate offline effects of the prior stimulation on brain activation in language and fronto-striatal networks. This is measured using functional magnetic resonance imaging (fMRI) during an fMRI-adapted language task immediately after the stimulation session. The Blood Oxygen Level-Dependent (BOLD) signal acquired following active TIS will be compared to the signal acquired following placebo (sham) TIS. | Immediately following the 20-minute stimulation session (approximately 0 to 30 minutes post-stimulation). |
| Changes in Resting-State Functional Connectivity | Evaluation of short-term neuroplasticity and network-level changes induced by the stimulation. Resting-state functional magnetic resonance imaging (rs-fMRI) data acquired immediately after the active TIS session will be compared to rs-fMRI data acquired after the placebo (sham) TIS session to identify changes in functional connectivity between the targeted striatum and broader cortical language networks. | Immediately following the 20-minute stimulation session (approximately 0 to 30 minutes post-stimulation). |
| Behavioral Performance in Sentence Comprehension Task | Evaluation of language processing measured by accuracy (number or percentage of correct responses) and reaction time (in milliseconds) during the Sentence Comprehension Task. This task is completed by the participant concurrently with the administration of either active Temporal Interference Stimulation (TIS) or placebo (sham) TIS outside of the MRI scanner. | During the approximately 20-minute stimulation intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ľubomíra Nováková, Ph.D. | Contact | +420 549 497 766 | lubomira.novakova@ceitec.muni.cz |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CEITEC MU (Central European Institute of Technology, Masaryk University) | Recruiting | Brno | South Moravian | 625 00 | Czechia |
The study follows Open Science and FAIR data principles, adhering to the standard of 'as open as possible, as closed as necessary.' IPD, including neuroimaging and behavioral data collected at the CEITEC MAFIL laboratory, are considered sensitive personal data. Therefore, data will be strictly anonymized. Fully anonymized participant data will be made publicly available via trusted data repositories (such as Zenodo or Figshare) and assigned a persistent identifier (DOI). For any specific datasets where full anonymization is not possible due to the sensitive nature of the data and privacy protection regulations, the raw IPD will not be shared; instead, only the metadata will be published.
The anonymized data will be stored and made available for a minimum of 5 years after the completion of the project.
Open access via repositories (Zenodo/Figshare) for fully anonymized data.
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| Placebo / Sham TIS | Device | Placebo stimulation applied for approximately 20 minutes while the participant performs a sentence comprehension task. |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D019636 | Neurodegenerative Diseases |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D009422 | Nervous System Diseases |
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