Effectiveness and Safety of GyroGlove in Stabilising Hand Tremors in Essential Tremor
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- GyroGear Ltd
- 入组人数
- 30
- 试验地点
- 14
- 主要终点
- Change from Baseline to Week- 2 (follow-up assessment) on The Essential Tremor Rating Assessment Scale (TETRAS) composite outcome score performance in ET participants
研究概览
简要总结
This is a multi-centre, single-blind, placebo-controlled trial with an open label follow up. After the baseline assessment, all participants will receive the GyroGlove for two weeks during the open label follow up part of the trial. All gloves will be retrieved and returned to GyroGear after closure of the study.
详细描述
All participants will attend 2 in-clinic assessment sessions (Baseline (day 0), Follow-up (day 14)) after screening visit. The baseline session will last approximately 120 minutes whilst the 2-week assessment will last approximately 60-80 minutes. At baseline assessment, participants will perform protocol-specific activities with both investigational devices (i.e. GyroGlove and Placebo).
In addition to in-clinic assessments, participants will complete self-assessments at Day -3 prior baseline visit (i.e. Day 0,) and at Day 5 and 10 from baseline (i.e. Day 0), when they started using GyroGlove at home.
All participants will be blinded at the baseline (Day 0), as assessments will be performed with GyroGlove and a placebo device in a pre-defined sequence. Each participant will act as the control for him/herself and will be blinded to the interventions order.
The sequence of interventions in the study has been pre-defined, owing to the potential for longitudinal effects of wearing the device interfering with the accurate study outcome measurement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The study is a single-blind study where study participants will be blinded to the order of both devices (investigational device and placebo) during baseline visit.
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
- •18 years of age or older
- •Subject has been clinically diagnosed with ET
- •Has either unilateral or bilateral tremor of the hand or predominantly hand as well as forearm
- •Has a score of ≥ 2 in ADL activities 2, 3, 6 & 8 of the TETRAS ADL subscale (TRG, Sep 2021)
- •Tremor in at least one hand causing water spillage during drinking
- •Stable dosage of medications throughout the duration of the study, if applicable
- •Ability to speak and read in the language that the trial documentation has been translated to.
- •Ability to understand verbal instructions in the language that the trial documentation has been translated to.
- •Ability to provide written informed consent to participate in the study
- •Capacity to complete self-report outcome measures in the language that the trial documentation has been translated to
排除标准
- •Other possible causes of tremor, including Parkinson's disease, drug-induced, enhanced physiological tremor
- •Presence of tremor around the elbow and shoulder limiting participants to perform required test/procedure in the study
- •Has implanted electrical medical device, e.g., pacemaker, defibrillator, or deep brain stimulator
- •Clinically diagnosed alcohol use disorder or illicit substance use (exception medical cannabis)
- •Change in medication for tremor within 1 month prior to study enrolment
- •Change in antidepressant medication within 3 months prior to study enrolment
- •Has received botulinum toxin injection for hand tremor within 4 months prior to study enrolment
- •Has been diagnosed with any of the following conditions affecting the hand and/or arm:
- •Fingers/Wrist joint defects or deformities or current skeletal injuries that prevent them from wearing the glove
- •Hand muscular deformities or weakness, e.g.: Myotonic Dystrophy, Autosomal Recessive Muscular Dystrophy limiting participant to perform required test/procedure in the study
- •Skin Conditions of the hand and forearm, e.g.: Eczema, Psoriasis, Extreme Skin Sensitivity
- •Growth or Development Defects of the hand, including but not limited to, Brittle Bone Disease, Triphalangeal Thumb.
- •Previous thalamotomy procedure, including stereotactic thalamotomy, gamma knife radio surgical thalamotomy, and focused ultrasound for the treatment of tremor.
- •Neurological conditions aside from essential tremor that may affect the conduct of the study
- •Peripheral neuropathy affecting the upper extremity
- •Are participating or have participated in any interventional clinical trial or study in the last 30 days which may confound the results of this study, unless approved by the Sponsor
- •Inability to follow simple instructions
- •Pregnancy
研究组 & 干预措施
No Interventional
Participants will perform protocol-specific tasks with no device
Investigational Device Arm
GyroGlove
干预措施: GyroGlove (Device)
Placebo Arm
Placebo
干预措施: Placebo (Device)
结局指标
主要结局
Change from Baseline to Week- 2 (follow-up assessment) on The Essential Tremor Rating Assessment Scale (TETRAS) composite outcome score performance in ET participants
时间窗: Day-0 (Baseline) and Day-14 (follow-up)
The Essential Tremor Rating Assessment Scale (TETRAS) composite outcome score is the sum of modified items 2, 3, 6 \& 8 of the TETRAS-ADL (Activities of Daily Living) subscale and modified items 6 - 7 of the TETRAS-PS (performance subscale). The TETRAS-ADL subscale is a patient-rated scale administered by a trained interviewer that assesses the impact of tremor on day-to-day functioning, such as feeding with a spoon, drinking from a glass, pouring, using keys etc. The TETARS-PS is a clinical rating scale that quantifies tremor in the head, face, voice, limbs and trunk. Items 6 (drawing an Archimedes spiral) and 7 (handwriting) of the TETRAS-PS evaluate the impact of upper limb tremor on performance. Each item from the modified subscales ranges from 0 - 4, with 0 representing normal and 4 representing severely abnormal. The sum of the 6 items provides the TETRAS composite outcome score, which ranges from 0 - 24, with higher scores representing more severe ET.
次要结局
- Change in performance in a subset of The Essential Tremor Rating Assessment Scale- performance subscales (TETRAS-PS) between baseline and follow-up assessment in ET participants.(Day-0 (Baseline) and Day-14 (follow-up))
- Change in Clinical Global Impression- Improvement scale (CGI-I) score between placebo and GyroGlove(Day-0 (Baseline))
- Change in performance in a subset of The Essential Tremor Rating Assessment Scale- performance subscales (TETRAS-PS) between GyroGlove and placebo device at baseline in ET participants(Day-0 (Baseline))
- Change in Patient Global Impression- Improvement scale (PGI-I) score between placebo and GyroGlove(Day-0 (Baseline))
- Percentage of participants with Investigational devices-related adverse events as assessed by CTCAE v4.0(Upto Day-14)
- Change in performance in a subset of The Essential Tremor Rating Assessment Scale- Activities of Daily Living (TETRAS ADL) subscales between baseline and follow-up assessment in ET participants(Day-0 (Baseline) and Day-14 (follow-up))
- Change in participants' experience of GyroGlove after 2-week intervention(Day-14 (follow-up))
- Change in the Quality of Life in Essential Tremor Questionnaire (QUEST) score between baseline and follow-up assessment in ET participants(Day-0 (Baseline) and Day-14)
- Change in Patient Global Impression- Improvement scale (PGI-I) score between baseline and follow-up assessment in ET participants(Day-0 (Baseline) and Day-14 (follow-up))
- Change in EQ-5D-5L score between baseline and follow-up assessment in ET participants(Day-0 (Baseline) and Day-14 (follow-up))
- Change in performance in a subset of the Bain and Findley ADL tasks from Day-1 to Day-14(Day-1 to Day-14)
- Change in Clinical Global Impression- Improvement scale (CGI-I) score between baseline and follow-up assessment in ET participants(Day-0 (Baseline) and Day-14 (follow-up))