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临床试验/NCT04509349
NCT04509349Unknown不适用

Alternating Current Stimulation for Essential Tremor: a Pilot Study to Identify the Most Promising Strategy

University of Calgary0 个研究点目标入组 30 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
主要终点
Essential Tremor Severity Change

研究概览

简要总结

Movement disorders are common neurological disorders, characterized by either excess or paucity of movements. Essential tremor (ET) is one of the most common of these disorders, defined as chronic, rhythmic involuntary movements (tremor) that occur primarily during action involving the upper extremities as prominent body site. ET occurs in between 0.4% and 4% of adults below age 60, its prevalence and related impairment of routine daily actions increasing dramatically with age. More than half of patients do not regain functional independence with medications. These patients are offered functional neurosurgical approaches that carry procedural risk or adverse effects secondary to deep electric stimulation of surgical lesioning. Hence, there is a substantial need for alternative, non-invasive therapeutic options for this disabling neurological disorder. Recently, non-invasive neuromodulation applied as transcranial alternating current stimulation (tACS), has emerged as promising for tremor control. In healthy subjects, tACS applied with a high definition (or focused) montage to the primary motor cortex (M1), was found to entrain physiological tremor; in patients with Parkinson's disease, tACS could decrease the amplitude of rest tremor when the stimulation was delivered in phase with, and at the same frequency of, the tremor. Tremor in ET could also be entrained applying ACS to the arm skin's peripheral nerves (transcutaneous ACS), but its effect on tremor amplitude is unknown.

METHODS AND POTENTIAL CONTRIBUTION/IMPACT OF THE RESEARCH.

The proposed project aims to explore the whole potential of tACS for the tremor suppression in ET. The investigators aim to test the following hypotheses:

  1. focused (or high definition, HD) tACS delivered over M1 at the same frequency of the tremor is effective in decreasing tremor amplitude in ET;
  2. this effect is strongest when the delivery of tACS is locked to the phase of the tremor expressed by the patient, i.e. administering tACS in a closed-loop modality;
  3. transcutaneous ACS in the upper extremities is as effective as tACS applied to the scalp around M1.

详细描述

This investigation will collect preliminary data on the efficacy of real vs. sham, as well as unlocked vs. phase-locked, modalities of tACS and transcutaneous ACS on tremor amplitude in 25 patients with ET.

Comparing transcranial and transcutaneous, as well as unlocked and phase-locked, modalities represents the novelty of our approach. This has the potential to generate a wealth of preliminary data forming the basis of a large, randomized controlled trial of multiple sessions of this intervention, hence potentially capable of producing long-lasting effects, in this common and disabling disorder. Given its non-invasiveness and relatively low cost, this approach has, if effective, a huge therapeutic potential 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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants who meet Diagnostic and Statistical Manual of Mental Disorders criteria for ET (APA, DSM V).
  • 18 years of age or older.
  • Participants should be either un-medicated or on stable medication treatment for tremor for the previous 3 months.
  • Psychiatric comorbidities should be clinically stable; treatment has not changed in the last 3 months.

排除标准

  • Have a metal object/implant in their brain, skull, scalp, or neck.
  • Have an implantable device (e.g., cardiac pacemaker).
  • Have a diagnosis of epilepsy or cardiac disease.
  • Have a history of traumatic brain injury, learning disability or dyslexia.
  • Have a severe impediment in vision or hearing.

结局指标

主要结局

Essential Tremor Severity Change

时间窗: Right before and immediately after the intervention

The tremor severity will be assessed in the participants by a Movement Disorders Neurologist.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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