Parcel-guided Transcranial Magnetic Stimulation for Anxiety in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Recruitment Rate
研究概览
简要总结
Parkinson's disease (PD) is the second most common neurodegenerative disease after Alzheimer's dementia. Anxiety in PD is common, has major effects on quality of life and contributes to increased disability. The reported prevalence of anxiety in PD ranges widely and is estimated up to 40%. Treatment with oral medications is not always effective or tolerated. TMS has been shown to be effective and safe in anxiety and general anxiety disorder (GAD), but there is only limited data available for Transcranial Magnetic Stimulation (TMS) treatment of anxiety in PD. Area 8Av is a parcellation based on Human connectome project within the left prefrontal cortex and is associated with GAD. Given the area's associations with mood disorders, its functional connectivity with large-scale brain networks involved in PD, and its anatomical accessibility by TMS, this may be an important target for anxiety in PD.
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
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has Idiopathic PD defined by the cardinal sign, bradykinesia, plus the presence of at least 1 of the following: resting tremor or rigidity and without any other known or suspected cause of Parkinsonism (according to MDS clinical diagnostic criteria for Parkinson's disease (42) Postuma et al, Movement Disorders 2015), confirmed by a fellowship trained movements disorder specialist.
- •Subject has a diagnosis of anxiety based on PAS (Parkinson's anxiety scale) score of ≥ 14
- •Subject is Hoehn & Yahr stage less than or equal to 3
- •Subject has a MOCA score ≥ 18
- •Subject is ≥ 40 and ≤ 90 years of age
- •Female subjects are post-menopausal or have a negative pregnancy test
- •The subject must be proficient in speaking, reading and understanding English in order to comply with procedural testing
- •Subject has provided informed written consent prior to participation. In the event that subject is legally unable to provide informed written consent due to deterioration in cognitive abilities, fully informed written consent must be provided by a legally authorized representative.
- •Subject is on a stable dose (at least 1 month prior to baseline visit) of antiparkinsonian agents and is willing to remain on this dose for the duration of the study. If the subject is on a anti-depressant or anti-anxiety medication, a stable dose without changes for 1 month is also required.
排除标准
- •Inability to tolerate imaging; contraindication of imaging due to implants or metal. This includes an implanted deep brain stimulation device.
- •Seizure disorder, active alcohol or substance use disorder.
- •Inability to speak and read English.
- •Anything else that, in the opinion of the PI/Clinician, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study.
- •Subject has atypical Parkinson's syndrome(s) due to drugs (e.g., metoclopramide, neuroleptics), metabolic neurogenetic disorders (e.g., Wilson's Disease), encephalitis, cerebrovascular disease, or degenerative disease (e.g., Progressive Supranuclear Palsy, Multiple System Atrophy, Corticobasal Degeneration, Lewy Body dementia)
- •Other forms of advanced dementia (PDD, AD), or MOCA <18
- •Subject has history of any of the following: moderate to severe pulmonary disease, poorly controlled congestive heart failure, significant cardiovascular and/or cerebrovascular events within previous 6 months, or any other clinically relevant abnormality that inclusion would pose a safety risk to the subject as determined by investigator.
- •Subject has history of any psychiatric illness that would pose a safety risk to the subject as determined by investigator.
- •Subject is currently taking sedative medications that are clinically contraindicated as determined by investigator.
- •Subject has undergone a recent change (<1 month) in their anti-parkinsonian medication, or anti-depressant medication or anti-anxiety medication at the baseline visit.
- •Safety risk to the subject as determined by investigator.
- •Subject has participated in a clinical trial investigation within 3 months of this study
研究组 & 干预措施
Theta burst stimulation
Subjects will receive treatment with intermittent theta burst stimulation (iTBS) with the active coil. There will be a total of 27 sessions over a 3-week period with 3 sessions per day. All subjects will receive iTBS to the left 8Av region. Total participation will be 8-12 weeks.
干预措施: Theta burst stimulation active coil (Device)
Sham device
Subjects will receive treatment with sham coil. There will be a total of 27 treatments over a 3-week period. Coil will be placed over the same region as the experimental group. Total participation will be 8-12 weeks.
干预措施: Sham coil (Device)
结局指标
主要结局
Recruitment Rate
时间窗: screening
Percentage of participant who enroll and consent based on those contacted. A higher percentage indicates higher feasibility.
Participation Rate
时间窗: 3 weeks
Percentage of participant who start treatment after enrollment. A higher percentage indicates higher feasibility.
Fidelity
时间窗: 2 weeks
Percentage of participant who complete all treatment sessions. A higher percentage indicates higher fidelity.
Completion Rate
时间窗: 2 weeks
Percentage of participant who complete 7 of the 9 treatment visits. A higher percentage indicates higher completion.
Adverse Events Rate - Safety
时间窗: up to 12 weeks
Percentage of participant with adverse events. A lower percentage indicates a safer treatment.
Adverse Events Safety
时间窗: up to 12 weeks
Frequency of each adverse event. A higher frequency indicates a less safe treatment.
次要结局
- Average change between baseline and 1 week post-treatment TMS vs Sham - Anxiety Scale(baseline, 1 week post-treatment)
- Average change between baseline and 1 week post-treatment TMS vs Sham - Cognitive scale(baseline, 1 week post-treatment)
- Average change between baseline and 1 week post-treatment TMS vs Sham - Mood(baseline, 1 week post-treatment)
- Average change between baseline and 1 week post-treatment TMS vs Sham - Motor(baseline, 1 week post-treatment)
- Pre-post change between baseline and 1 week post-treatment within individuals in active TMS group - Anxiety Scale(baseline, 1 week post-treatment)
- Pre-post change between baseline and 1 week post-treatment within individuals in active TMS group - Cognitive scale(baseline, 1 week post-treatment)
- Pre-post change between baseline and 1 week post-treatment within individuals in active TMS group - Mood(baseline, 1 week post-treatment)
- Pre-post change between baseline and 1 week post-treatment within individuals in active TMS group - Motor(baseline, 1 week post-treatment)
- Responder Rate(baseline, 1 week post treatment)