Phase II Trial of Non-Invasive Intermittent Theta Burst Stimulation of the Dorsolateral Prefrontal Cortex in Functional Movement Disorders
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- S-FMDRS
研究概览
简要总结
Background:
Functional movement disorders (FMD) involve involuntary movements that are not due to a recognized neurological or medical cause. FMD can cause major disability. Researchers want to learn more to create better treatments for FMD.
Objective:
To test whether non-invasive brain stimulation using transcranial magnetic stimulation (TMS) improves FMD symptoms.
Eligibility:
People between the ages of 18 and 80 who have been diagnosed with FMD by a neurologist.
Design:
Participants will be randomly assigned to one of two groups. One group is an active brain stimulation group and the other is a sham brain stimulation group.
Participants will have a baseline visit. This will include:
Neurological exam
Questionnaires
Urine test
Brain MRI: Participants will lie in a machine that takes pictures of the body. They will be asked to respond to images on a screen while in the scanner.
Within 2 weeks of the baseline visit, participants will begin 5 daily sessions of TMS. The active group will have stimulation delivered to the brain via a coil. In the sham group, a dummy coil will be used that will not deliver stimulation. A total of three 3-minute cycles will be done in one visit. There will be 20-minute breaks between the cycles.
Participants will have visits 1 month, 2 months, and 6 months after their last day of TMS. Their FMD symptoms will be evaluated. They will complete health questionnaires. These visits can be in person or virtual.
详细描述
Study Description:
The purpose of this protocol is to investigate efficacy of intermittent theta burst stimulation (iTBS) targeting the left dorsolateral prefrontal cortex (DLPFC) in patients with functional movement disorders (FMD). Participants will be randomly assigned to receive either active iTBS or sham stimulation of the left DLPFC for 5 consecutive daily sessions.
Objectives:
Primary Objective: To investigate efficacy of iTBS of the left DLPFC on motor symptoms in patients with FMD
Secondary Objectives: To investigate efficacy of iTBS of the left DLPFC on mood symptoms and its effect on fronto-amygdala circuit on functional neuroimaging
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA:
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged 18-80
- •Diagnosis of functional movement disorder made by a neurologist
- •Agreement to adhere to Lifestyle Considerations throughout study duration
- •Ability of subject to understand and the willingness to sign a written informed consent document.
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Current psychosis or active suicidal ideation
- •History of epilepsy with the exception of febrile seizure
- •Patients with psychogenic non-epileptic seizure without comcomitant functional movement disorder
- •Any significant neurological disorders other than FMD including but not limited to multiple sclerosis, stroke, Parkinson s disease, space occupying brain lesion
- •Alcohol or substance use disorder
- •Patients who are on Buproprion (Wellbutrin)
- •Patients with moderate to severe cardiac disease
- •Any psychiatric, medical or social condition due to which, in the judgment of the PI and after any consults if indicated, participation in the study is not in the best interest of the patient.
- •Pregnancy
研究组 & 干预措施
Control
Sham TMS stimulation using a sham coil
干预措施: Sham Comparator (Other)
Treatment
Active TMS stimulation using an active TMS coil
干预措施: MagStim (Device)
结局指标
主要结局
S-FMDRS
时间窗: 1 month after iTBS
Short version of Functional Movement Disorder Rating Scale
Change in S-FMDRS at 1 Month After Real iTBS vs Sham iTBS
时间窗: 1 month after iTBS
The Simplified Functional Movement Disorders Rating Scale (S-FMDRS) measures abnormal movements in 7 body regions as well as gait and speech. Symptom severity in each body region is rated from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe) and duration from 0 to 3 (0=none; 1=occasionally, 2=frequent, 3= constant). All severity and duration scores are added to yield a total score. The total score ranges from minimum 0 to maximum 68, high score representing worse outcome.
次要结局
- S-FMDRS(2 and 6 months after iTBS)
- CGI(1, 2 and 6 months after iTBS)
- SF-36(1, 2 and 6 months after iTBS)
- Change in S-FMDRS at 2 and 6 Months After Real iTBS vs Sham iTBS(2 and 6 months after iTBS)
- Change in Hospital Anxiety and Depression Scale (HADS) at 1, 2 and 6 Months After Real iTBS vs Sham iTBS(At baseline and 1, 2 and 6 months after iTBS)
- CGI at 1, 2, and 6 Months After Real iTBS vs Sham iTBS(1, 2 and 6 months after iTBS)