Effect of Striatal Temporal Interference Stimulation on Language Processing in Neurodegenerative Diseases

February 27, 2026 updated by: Masaryk University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Czechia
    • South Moravian
      • Brno, South Moravian, Czechia, 625 00
        • Recruiting
        • CEITEC MU (Central European Institute of Technology, Masaryk University)
        • Contact:
        • Principal Investigator:
          • Ľubomíra Nováková, Ph.D.
        • Sub-Investigator:
          • Irena Rektorová, Prof. Ph.D.
        • Sub-Investigator:
          • Jiří Mekyska, Ph.D.
        • Sub-Investigator:
          • Jan Fousek, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Possible or probable Mild Cognitive Impairment with Lewy Bodies (MCI-LB), in Parkinson's Disease (MCI-PD) or Amnestic Mild Cognitive Impairment (aMCI).

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active TIS followed by Placebo TIS
Participants first receive single-session active TIS targeting the striatum for approx. 20 minutes. Following a washout period, they receive placebo (sham) TIS.
Device: Active Temporal Interference Stimulation (TIS)
Non-invasive brain interference stimulation applied for approximately 20 minutes while the participant performs a sentence comprehension task.
Device: Placebo / Sham TIS
Placebo stimulation applied for approximately 20 minutes while the participant performs a sentence comprehension task.
Experimental: Placebo TIS followed by Active TIS
Participants first receive single-session placebo (sham) TIS for approx. 20 minutes. Following a washout period, they receive active TIS targeting the striatum.
Device: Active Temporal Interference Stimulation (TIS)
Non-invasive brain interference stimulation applied for approximately 20 minutes while the participant performs a sentence comprehension task.
Device: Placebo / Sham TIS
Placebo stimulation applied for approximately 20 minutes while the participant performs a sentence comprehension task.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately following the 20-minute stimulation session (approximately 0 to 30 minutes post-stimulation).
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.
Immediately following the 20-minute stimulation session (approximately 0 to 30 minutes post-stimulation).
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.
During the approximately 20-minute stimulation intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Masaryk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

February 27, 2026

First Submitted That Met QC Criteria

February 27, 2026

First Posted (Actual)

March 4, 2026

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

February 27, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CZ.02.01.01/00/23_025/0008726

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

The anonymized data will be stored and made available for a minimum of 5 years after the completion of the project.

IPD Sharing Access Criteria

Open access via repositories (Zenodo/Figshare) for fully anonymized data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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