A Pilot Study to Assess the Effects of Pre-SMA LF-rTMS for the Treatment of Essential
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 主要终点
- Mean TRS (Tremor Rating Score)
研究概览
简要总结
The purpose of this study is to determine the effects of Low Frequency Repetitive Transcranial Magnetic Stimulation (LF r-TMS) of the pre-Supplementary Motor Area (pre-SMA) on tremor as measured by the tremor rating scale (TRS) in patients with Essential Tremor (ET).
Hypothesis: Pre-SMA LF r-TMS will result in a >30% reduction in tremor as measured by the TRS. Another purpose of this study is to identify the mechanism by which LF r-TMS of the pre-SMA effects tremor in patients with ET.
Hypothesis: Inhibition of the pre-SMA by LF r-TMS improves tremor in ET by normalizing pre-SMA output, and improving motor control, as determined shortening of the delay in the second agonist burst, seen in ET patients. At conclusion of this study expect to have sufficient pilot data to justify larger pivotal trials designed to establish the efficacy of pre-SMA r-TMS in ET.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Greater than 18 of age
- •Meet the diagnostic criteria for essential tremor with visible upper limb tremor
- •Must be either on stable medications to treat tremor for 30 days, or no medications to treat tremor
排除标准
- •History of seizures
- •History of chronic pain conditions
- •Any metal in their body above their shoulders
- •Use of medications that lower seizure threshold including:
- •broad classes of drugs such as tricyclic antidepressants
- •anti-psychotics
- •neuroeptics
- •thyroid medications and stimulants
- •Use of any medications that cause tremor, Pregnancy
研究组 & 干预措施
Active pre-SMA rTMS
The intervention to be administered is the MagVenture MagProx100 Stimulator with a Cool-B65 A/P coil l to administer active rTMS at 1Hz, 1,200sec, 110% resting motor threshold (rMT); 1200 pulses total. Two Thymapad Stimulus Electrodes will be placed in the appropriate position during active rTMS administration.This intervention method will be used for all 15 treatment sessions (20 minutes/session).
干预措施: MagVenture MagProx100 Stimulator with a Cool-B65 A/P coil (Device)
Sham pre-SMA rTMS
The intervention to be administered is the eSHAM system used in conjunction with the MagVenture MagProx100 Stimulator with the Cool-B65 A/P Coil. For eSHAM administration two Thymapad Stimulus Electrodes will be placed on the scalp location that corresponded to left DLPFC. This intervention method will be used for all 15 treatment sessions (20 minutes/session). Previous studies have shown the eSHAM system effectively blinds participants to rTMS treatment (active versus sham).
干预措施: eSHAM system (Device)
结局指标
主要结局
Mean TRS (Tremor Rating Score)
时间窗: Baseline (Visit 2) post intervention
Participants will be videotaped as they are being examined for the purpose of rating their tremor for the TRS. TRS scale is a range of 0 - 84 (0 being the least severe and 84 being the most severe tremor)
Mean TRS (Tremor Rating Score) at 4 Week Followup
时间窗: 4 week followup(visit 18)
Participants will be videotaped as they are being examined for the purpose of rating their tremor for the TRS. TRS scale is a range of 0 - 84 (0 being the least severe and 84 being the most severe tremor)
Mean TRS (Tremor Rating Score) at 12 Week Followup
时间窗: 12-week followup(visit 20)
Participants will be videotaped as they are being examined for the purpose of rating their tremor for the TRS. TRS scale is a range of 0 - 84 (0 being the least severe and 84 being the most severe tremor)
Mean TRS (Tremor Rating Score) at 8 Week Followup
时间窗: 8 week followup (visit 19)
Participants will be videotaped as they are being examined for the purpose of rating their tremor for the TRS. TRS scale is a range of 0 - 84 (0 being the least severe and 84 being the most severe tremor)
次要结局
未报告次要终点