Mild Cognitive Impairment (MCI) AmnesticNCT07449117
Effect of Striatal Temporal Interference Stimulation on Language Processing in Neurodegenerative Diseases
A study testing Active Temporal Interference Stimulation (TIS) in people with Mild Cognitive Impairment (MCI) Amnestic and Lewy Body Disease With Mild Cognitive Impairment, run by Masaryk University at 1 site in Czechia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Mild Cognitive Impairment (MCI) Amnestic, Lewy Body Disease With Mild Cognitive Impairment, Parkinson's Disease With Mild Cognitive Impairment
- What is being tested?
- Active Temporal Interference Stimulation (TIS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteCzechia
- Study dates
- Mar 2026to Dec 2028
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Possible or probable Mild Cognitive Impairment with Lewy Bodies (MCI-LB), in Parkinson's Disease (MCI-PD) or Amnestic Mild Cognitive Impairment (aMCI).
Who cannot join
- Any severe psychiatric disorder.
- History of other neurological diseases affecting the central nervous system.
- Severe head trauma.
- Uncompensated internal or oncological disease.
- Presence of MRI-incompatible metal in the body (e.g., pacemaker).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
CEITEC MU (Central European Institute of Technology, Masaryk University)
Brno, South Moravian, 625 00
Ľubomíra Nováková, Ph.D., +420 549 497 766, lubomira.novakova@ceitec.muni.cz
Ľubomíra Nováková, Ph.D.
About this study
Official title: Immediate Effects of Non-invasive Temporal Interference Stimulation Targeting Deep Fronto-Striatal Structures on Language Processing and Behavioral Performance in Patients With Neurodegenerative Diseases
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.
Read the detailed description
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.
- Conditions
- Mild Cognitive Impairment (MCI) Amnestic, Lewy Body Disease With Mild Cognitive Impairment, Parkinson's Disease With Mild Cognitive Impairment
- Being tested
- Active Temporal Interference Stimulation (TIS), Placebo / Sham TIS
- Keywords
- Temporal Interference Stimulation, Functional Magnetic Resonance Imaging, Sentence Comprehension, Language Processing, Brain Connectivity, Striatum, Fronto-striatal Circuit, Mild Cognitive Impairment, Neurodegenerative Diseases
- Medical subject headings
- Cognitive Dysfunction, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Temporal Interference Stimulation (TIS)Device
Non-invasive brain interference stimulation applied for approximately 20 minutes while the participant performs a sentence comprehension task.
Placebo / Sham TISDevice
Placebo stimulation applied for approximately 20 minutes while the participant performs a sentence comprehension task.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Active Temporal Interference Stimulation (TIS); Device: Placebo / Sham TIS |
| 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. Receives: Device: Active Temporal Interference Stimulation (TIS); Device: Placebo / Sham TIS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: During the approximately 20-minute stimulation intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI) AmnesticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masaryk University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07449117
- Sponsor's protocol ID
- CZ.02.01.01/00/23_025/0008726
- Status last verified
- Feb 2026
- First submitted
- 27 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of Non-invasive Temporal Interference Stimulation Targeting Deep Fronto-Striatal Structures on Language Processing and Behavioral Performance in Patients With Neurodegenerative Diseases
- ClinicalTrials.gov ID
- NCT07449117
- Acronym / sponsor ID
- CZ.02.01.01/00/23_025/0008726
- Conditions
- Mild Cognitive Impairment (MCI) Amnestic, Lewy Body Disease With Mild Cognitive Impairment, Parkinson's Disease With Mild Cognitive Impairment
- Keywords
- Temporal Interference Stimulation, Functional Magnetic Resonance Imaging, Sentence Comprehension, Language Processing, Brain Connectivity, Striatum, Fronto-striatal Circuit, Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Masaryk UniversityUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active TIS followed by Placebo TIS | Experimental | Device: Active Temporal Interference Stimulation (TIS), Device: Placebo / Sham TISParticipants first receive single-session active TIS targeting the striatum for approx. 20 minutes. Following a washout period, they receive placebo (sham) TIS. |
| Placebo TIS followed by Active TIS | Experimental | Device: Active Temporal Interference Stimulation (TIS), Device: Placebo / Sham TISParticipants first receive single-session placebo (sham) TIS for approx. 20 minutes. Following a washout period, they receive active TIS targeting the striatum. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Possible or probable Mild Cognitive Impairment with Lewy Bodies (MCI-LB), in Parkinson's Disease (MCI-PD) or Amnestic Mild Cognitive Impairment (aMCI).
Key exclusion criteria (5 listed)
- Any severe psychiatric disorder.
- History of other neurological diseases affecting the central nervous system.
- Severe head trauma.
- Uncompensated internal or oncological disease.
- Presence of MRI-incompatible metal in the body (e.g., pacemaker).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Temporal Interference Stimulation (TIS)Non-invasive brain interference stimulation applied for approximately 20 minutes while the participant performs a sentence comprehension task. | Device | Active TIS followed by Placebo TIS, Placebo TIS followed by Active TIS |
| Placebo / Sham TISPlacebo stimulation applied for approximately 20 minutes while the participant performs a sentence comprehension task. | Device | Active TIS followed by Placebo TIS, Placebo TIS followed by Active TIS |
Primary outcome
Changes in Task-Related Brain Activation
Time frame: Immediately following the 20-minute stimulation session (approximately 0 to 30 minutes post-stimulation).
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.
Changes in Resting-State Functional Connectivity
Time frame: Immediately following the 20-minute stimulation session (approximately 0 to 30 minutes post-stimulation).
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.
Behavioral Performance in Sentence Comprehension Task
Time frame: During the approximately 20-minute stimulation intervention.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Temporal Interference Stimulation (TIS) in people with Mild Cognitive Impairment (MCI) Amnestic and Lewy Body Disease With Mild Cognitive Impairment, run by Masaryk University at 1 site in Czechia.
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 1 inclusion and 5 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 4 Mar 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 Czechia. 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 Ľubomíra Nováková, Ph.D. (+420 549 497 766, lubomira.novakova@ceitec.muni.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Task-Related Brain Activation (time frame: Immediately following the 20-minute stimulation session (approximately 0 to 30 minutes post-stimulation).). The study lists 3 primary outcomes in all. 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 4 Mar 2026.