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

NCT07449117 | Recruiting

• 1 other identifier: CZ.02.01.01/00/23_025/0008726
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

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; Neurodegenerative Diseases

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (2)

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.

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.

Device: Active Temporal Interference Stimulation (TIS); Device: Placebo / Sham TIS

Interventions

Active Temporal Interference Stimulation (TIS) DEVICE

Non-invasive brain interference stimulation applied for approximately 20 minutes while the participant performs a sentence comprehension task.

Active TIS followed by Placebo TIS; Placebo TIS followed by Active TIS

Placebo / Sham TIS DEVICE

Placebo stimulation applied for approximately 20 minutes while the participant performs a sentence comprehension task.

Active TIS followed by Placebo TIS; Placebo TIS followed by Active TIS

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Masaryk University: lead

Study Sites (1)

CEITEC MU (Central European Institute of Technology, Masaryk University)

Brno, South Moravian, 625 00, Czechia

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Nervous System Diseases

Central Study Contacts

Ľubomíra Nováková, Ph.D.

CONTACT

+420 549 497 766; lubomira.novakova@ceitec.muni.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 4, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The anonymized data will be stored and made available for a minimum of 5 years after the completion of the project.
• Access Criteria: Open access via repositories (Zenodo/Figshare) for fully anonymized data.

Locations

CZ (1)