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临床试验/NCT03263013
NCT03263013已完成不适用

Non-invasive Intermittent Theta Burst Stimulation of the Dorsolateral Prefrontal Cortex in Patients With Functional Movement Disorders

National Institute of Neurological Disorders and Stroke (NINDS)1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2018年3月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
7
试验地点
1
主要终点
to evaluate the safety and feasibility of different doses of iTBS of the left DLPFC in patients with FMD.

研究概览

简要总结

Background:

Functional movement disorder (FMD) causes involuntary movements, such as spasms, shaking, or jerks. These symptoms are not due to a recognized neurological or medical cause. Researchers want to better understand how the brain works to cause these symptoms.

Objective:

To test if intermittent theta burst stimulation (iTBS) affects brain areas involved in FMD symptoms. Also, to look at the effect of iTBS on mood and motor symptoms.

Eligibility:

Right-handed people ages 18-65 who have FMD and participated in protocol 07-N-0190

Design:

Participants will have 4 visits.

In Visit 1, participants will be screened with:

Medical history

Physical exam

Urine test

Questionnaires

Visit 1 might also include a brain MRI and functional MRI. The MRI scanner is a cylinder surrounded by a strong magnetic field. They will lie on a table that can slide in and out of the cylinder. For the functional MRI, they will be asked to perform tasks during the MRI scan.

Visit 2 will be 1-2 weeks after Visit 1. Visits 2, 3, and 4 will be no more than 48 hours apart. These include:

Electromyography: Small electrodes are taped to the skin. Muscle activity is recorded while participants receive magnetic stimulation of the brain.

Transcranial magnetic stimulation and iTBS: A wire coil is held on the scalp. A brief electrical current passes through the coil and creates a magnetic pulse to stimulate the brain. During iTBS, participants will sit quietly and watch a nature documentary. They will wear earplugs and a cap.

MRI

Functional MRI

Questionnaires

详细描述

Objectives:

The purpose of this protocol is to investigate feasibility and safety of intermittent theta burst stimulation (iTBS) targeting the left dorsolateral prefrontal cortex (DLPFC) in patients with functional movement disorders (FMD). We further aim at exploring whether iTBS of the DLPFC modulates amygdala activity, by investigating iTBS effects on resting-state fronto-amygdala connectivity and on amygdala BOLD response to valenced stimuli.

Study population:

FMD patients (N=6), aged 18-65 years, admitted at the Human Motor Control Section (HMCS) clinic, who have completed protocol 07-N-0190.

Design:

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

to evaluate the safety and feasibility of different doses of iTBS of the left DLPFC in patients with FMD.

时间窗: throughout life of the protocol

Percent of subjects experiencing adverse events (i.e., seizures, etc.)

次要结局

未报告次要终点

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (1)

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