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NCT Number: NCT07449117

Effect of Striatal Temporal Interference Stimulation on Language Processing in 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.

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Key information

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Brno, South Moravian, 625 00, Czechia

Location status: Recruiting

Location contact

Irena Rektorová, Prof. Ph.D.

SUB_INVESTIGATOR

Jan Fousek, Ph.D.

SUB_INVESTIGATOR

Jiří Mekyska, Ph.D.

SUB_INVESTIGATOR

Ľubomíra Nováková, Ph.D.

CONTACT

[email protected]

+420 549 497 766

Ľubomíra Nováková, Ph.D.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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 TIS

Device

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ľubomíra Nováková, Ph.D.

CONTACT

[email protected]

+420 549 497 766

Sponsors and collaborators

Lead sponsor

Masaryk University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 4, 2026
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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