Cerebellar Transcranial Magnetic Stimulation for Motor Control in Progressive Supranuclear Palsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- objective posturography
研究概览
简要总结
The objective of this proposal is to investigate the effect of non-invasive repetitive cerebellar transcranial magnetic stimulation (rTMS) on motor control in progressive supranuclear (PSP). The central hypothesis is that augmenting cerebellar inhibition via cerebellar rTMS will decrease postural instability in patients with PSP. We will use functional near infrared spectroscopy (fNIRS) to examine changes in motor and premotor cortical activity after cerebellar rTMS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The subjects will be blinded to the order of intervention, but the PI will not be blinded in order to perform the TMS intervention. The outcome evaluators will be blinded to the intervention, however.
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •probable or possible PSP by the revised MDS PSP Criteria (Hoglinger 2017)
- •age 40-85 at time of screening
- •ability to understand and cooperate with simple instructions in English
- •ability to read at 6th grade reading level in English
- •ability to stand unassisted for at least 30 seconds and to be able walk independently with a walker
- •ability to refrain from new physical and speech therapy programs for the duration of the study
- •ability to remain on stable doses of any cholinergic, dopaminergic, serotonergic sedative or NMDA receptor antagonists for the duration of the study
- •females of child-bearing age must perform a urine pregnancy test and be on reliable birth control during the course of the study
排除标准
- •other significant neurological or vestibular disorders
- •presence of electrically, magnetically or mechanically activated implants or history of injurious metal exposure in eyes, head, or body
研究组 & 干预措施
Active TMS first
After completing their baseline assessment, participants randomized to this arm will initially take part in a 2-week TMS intervention. After the midpoint assessment and subsequent a 1-month washout, these participants will then complete a 2-week sham TMS period prior to their final assessment.
干预措施: Repetitive transcranial magnetic stimulation (rTMS) (Device)
Sham treatment first
After completing their baseline assessment, participants randomized to this arm will initially take part in a 2-week sham TMS period. After the midpoint assessment and subsequent a 1-month washout, these participants will then complete a 2-week TMS intervention prior to their final assessment.
干预措施: Repetitive transcranial magnetic stimulation (rTMS) (Device)
结局指标
主要结局
objective posturography
时间窗: assessed on 4 days during the 8 week study period
The primary endpoint is center of pressure shifts with tilt and with translation, and body sway in quiet stance.
次要结局
- fNIRS(assessed on 4 days during the 8 week study period)
- speech analysis(assessed on 4 days during the 8 week study period)
研究者
Marian L Dale, MD
Associate Professor of Neurology, School of Medicine; Director, OHSU CurePSP Center of Care
Oregon Health and Science University