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临床试验/NCT05016765
NCT05016765已完成不适用

Open Trial of Median Nerve Stimulation for Treatment of Tourette Syndrome

Washington University School of Medicine2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2021年11月18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
31
试验地点
2
主要终点
Time Spent Using the Device (Days Per Week)

研究概览

简要总结

A recent report (Morera Maiquez et al 2020) described reduced tic severity in people with Tourette syndrome during 1-minute epochs of median nerve stimulation (MNS) at 10 Hz. Among the various questions still to be answered is the question of whether a device to administer MNS is practical for use in a chronic, real-world setting. This study will recruit participants who complete the clinic-based, blinded, randomized controlled trial, https://clinicaltrials.gov/ct2/show/NCT04731714, to determine the real-world usage and apparent utility of median nerve stimulation in people with chronic tics.

详细描述

Chronic tic disorders (CTD), including Tourette syndrome (TS), are associated with a substantially reduced quality of life (Evans et al 2016). Medication treatments are no more than 50-60% effective in randomized, controlled trials (RCTs), and are often discontinued due to unacceptable side effects (Thomas and Cavanna 2013). Behavioral therapies require ability to participate in therapy and a specially trained therapist (Scahill et al 2013), but weekly visits to psychologists are impractical for many Americans, especially in rural areas (Lin et al 2016). Patients strongly desire new treatment options (Cuenca et al 2015).

In June, 2020, Stephen Jackson's group at the University of Nottingham published a fascinating report in Current Biology on a potential novel treatment for tics (Morera Maiquez et al 2020). The radical new idea arose from observations associating movement inhibition with 8-14 Hz activity in motor cortex. They first showed that rhythmic 12 Hz peripheral stimulation of the median nerve evoked synchronous contralateral EEG activity over primary sensorimotor cortex, whereas arrhythmic stimulation at the same mean rate did not. As hypothesized, median nerve stimulation (MNS) at 12 Hz created small but statistically significant effects on initiation of voluntary movements. Importantly, they also demonstrated that this stimulation did not meaningfully impair concentration, suggesting that the effect did not operate through simple distraction. They went on to test 10 Hz MNS in 19 TS patients, and demonstrated using blinded video ratings a significant reduction in tic number and severity during 1-minute stimulation epochs vs 1-minute no-stimulation epochs. They noted that in some participants, benefit lasted beyond the end of the stimulation epoch [personal correspondence]. Videos accompanying the publication showed dramatic benefit during MNS in some subjects. Although the authors appropriately noted the steps needed to generalize these results to clinical practice, news reports already have led a number of TS patients to contact them asking for treatment. The Nottingham group has referred such inquiries from the U.S. to me as leader of our Wash.U. Tourette Association of America (TAA) Center of Excellence.

Among the various questions still to be answered is the question of whether such a device would be practical for use in the real world. This study will supply participants with a commercially available transcutaneous electrical nerve stimulation (TENS) units to use for median nerve stimulation as described in the Nottingham study. Participants will be told to use the device as much or as little as desired to see how such stimulation might be utilized in the real world.

Here the investigators propose (a) to determine the real-world usage and apparent utility of stimulation in people with chronic tics, and (b) to determine momentary self-rated efficacy and side effects of stimulation. The investigators will also compare results from this study to those from the "Peripheral induction of inhibitory brain circuits to treat Tourette's: pilot" study, from which participants will be drawn, in order to compare laboratory and real-world efficacy.

Aim 1. Determine the real-world usage and apparent utility of stimulation in people with chronic tics. Participants will be allowed to choose when and for how long to use the stimulation, thus simulating how patients would use the stimulation in their daily lives.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Completed participation in the study called "Peripheral induction of inhibitory brain circuits to treat Tourette's: pilot"
  • Informed consent by adult participant, or assent by child and informed consent by guardian

排除标准

  • Has an implanted device that could be affected by electrical current
  • Pregnancy known to participant or (for children) to the parent
  • Severe or unstable systemic illness
  • Factors (such as exaggerated symptom report) that in the judgment of the principal investigator may make the outcome measures inaccurate
  • Judged by investigator to be unlikely to complete study procedures

结局指标

主要结局

Time Spent Using the Device (Days Per Week)

时间窗: At study conclusion, up to 4 weeks

Number of days per week the device was used

Plan to Continue MNS (Median Nerve Stimulation)

时间窗: At study conclusion, up to 1 month

Answered yes (from options yes / no / maybe) to the question, "Do you expect to continue to use the stimulator?"

Time Spent Using the Device Per Day of Use

时间窗: At study conclusion, up to 4 weeks

Number of minutes per day the device was used, only counting days in which the device was turned on, over the four-week period after the initial visit

Change in Tic Frequency With Stimulation

时间窗: Recorded every time the device was turned on and every time it was turned off, up to 4 weeks

Change in self-reported tic frequency on the frequency item (score range from 0 = no tics \[better\] to 5 = always \[worse\]) from the Yale Global Tic Severity Scale (YGTSS) from the beginning to the end of each stimulation period. Participants were instructed to answer this question every time they turned on the device and every time they turned it off, every day for 4 weeks. The difference between the turning off score and the previous turning on score was averaged across all ratings completed during the 4 weeks of the trial. The wording of the score anchors is provided at https://osf.io/7pjk4 .

Change in Tic Intensity With Stimulation

时间窗: Recorded every time the device was turned on and every time it was turned off, up to 4 weeks

Change in self-reported tic intensity on the intensity item (score range from 0 = no tics \[better\] to 5 = severe intensity \[worse\]) from the Yale Global Tic Severity Scale (YGTSS) from the beginning to the end of each stimulation period. Participants were instructed to answer this question every time they turned on the device and every time they turned it off, every day for 4 weeks. The difference between the turning off score and the previous turning on score was averaged across all ratings completed during the 4 weeks of the trial.

Discomfort

时间窗: Recorded every time the device was turned off, and every time the participant was prompted by a text to fill out the survey if the device was on when the text was received, up to 4 weeks.

Mean discomfort while using the stimulator, on a 0-3 scale adapted from the Clinical Global Impression - Improvement \[CGI-I\] Efficacy Index. Specifically, the prompt was "How much DISCOMFORT did the stimulation cause?", and the participant selected one of the following responses: 0 = NO discomfort 1. = discomfort noticeable, but not severe enough to concern me or to turn it off 2. = enough discomfort, impairment of functioning or social embarrassment that I would only keep it on if the benefit was considerable 3. = caused discomfort, impairment of functioning or social embarrassment to a degree that any treatment benefit was not worth leaving it on Higher values represent a worse outcome. Discomfort was reported at the end of each stimulation period, and at random times twice daily between 9a.m. and 9p.m. when prompted by text message, if the device was on when the text was received.

次要结局

  • Self-reported Duration of MNS Benefit, in Minutes(Monitored over the entire period of study participation, up to 4 weeks)
  • CGI Efficacy Index: Side Effects(At study conclusion, up to 4 weeks)
  • Mean Therapeutic Effect During Stimulator Use(At study conclusion, up to 4 weeks)
  • CGI-I (Clinical Global Impression--Improvement)(At study conclusion, up to 4 weeks)
  • Change in Self-reported Tic Severity(At beginning of study participation or up to 2 weeks prior, and again at end of study participation up to 4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kevin J. Black, M.D.

Principal Investigator

Washington University School of Medicine

研究点 (2)

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