Immediate Effects of Non-invasive Temporal Interference Stimulation Targeting Deep Fronto-Striatal Structures on Language Processing and Behavioral Performance in Patients With Neurodegenerative Diseases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Changes in Task-Related Brain Activation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Possible or probable Mild Cognitive Impairment with Lewy Bodies (MCI-LB), in Parkinson's Disease (MCI-PD) or Amnestic Mild Cognitive Impairment (aMCI).
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: Active Temporal Interference Stimulation (TIS) (Device)
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.
干预措施: Placebo / Sham TIS (Device)
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.
干预措施: Active Temporal Interference Stimulation (TIS) (Device)
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.
干预措施: Placebo / Sham TIS (Device)
结局指标
主要结局
Changes in Task-Related Brain Activation
时间窗: 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.
Changes in Resting-State Functional Connectivity
时间窗: 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.
Behavioral Performance in Sentence Comprehension Task
时间窗: 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.
次要结局
未报告次要终点