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Recruiting NCT07449117

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

No phase Interventional Mild Cognitive Impairment (MCI) Amnestic Lewy Body Disease With Mild Cognitive Impairment Parkinson's Disease With Mild Cognitive Impairment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Active Temporal Interference Stimulation (TIS), Placebo / Sham TIS.
Who it may be relevant to
Registry conditions: Mild Cognitive Impairment (MCI) Amnestic, Lewy Body Disease With Mild Cognitive Impairment, Parkinson's Disease With Mild Cognitive Impairment. Basic parameters: 60 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Czechia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Changes in Task-Related Brain Activation [Time frame: 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).]
  • Behavioral Performance in Sentence Comprehension Task [Time frame: During the approximately 20-minute stimulation intervention.]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Basic science

Study locations

Czechia · 1 center
  • CEITEC MU (Central European Institute of Technology, Masaryk University) — Brno

Identifiers

NCT: NCT07449117 · CZ.02.01.01/00/23_025/0008726

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗