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

ConditionsMild Cognitive Impairment (MCI) AmnesticLewy Body Disease With Mild Cognitive ImpairmentParkinson's Disease With Mild Cognitive Impairment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-80
SponsorMasaryk University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Any severe psychiatric disorder.

History of other neurological diseases affecting the central nervous system.

Severe head trauma.

Uncompensated internal or oncological disease.

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Active TIS followed by Placebo TISExperimental treatment 2 interventions
Group B: Placebo TIS followed by Active TISExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Immediately following the 20-minute stimulation session (approximately 0 to 30 minutes post-stimulation).
2

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.

Time frame
Immediately following the 20-minute stimulation session (approximately 0 to 30 minutes post-stimulation).
3

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.

Time frame
During the approximately 20-minute stimulation intervention.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Masaryk University

Lead sponsor

Source ClinicalTrials.gov
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