GyroGlove Use in Essential Tremor Patients

Официальное название

Effectiveness and Safety of GyroGlove in Stabilising Hand Tremors in Essential Tremor

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Placebo
  The placebo device consists of the same hardware as GyroGlove: aesthetically it looks the same, weight same and produces the same noise as GyroGlove. Participants will interact with Placebo on the day of baseline visit (i.e. Day 0).
• Устройство GyroGlove
  GyroGlove is a patented wearable device containing high-performance, miniaturised, gyroscopes designed for individuals diagnosed with essential tremor. Participants will interact with GyroGlove on the day of baseline visit (i.e. Day 0), 2-week Home use and on the day of follow-up visit (i.e Day 14).

Первичные конечные точки

• Change from Baseline to Week- 2 (follow-up assessment) on The Essential Tremor Rating Assessment Scale (TETRAS) composite outcome score performance in ET participants [Срок оценки: Day-0 (Baseline) and Day-14 (follow-up)]

Вторичные конечные точки (12)

• 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 [Срок оценки: Day-0 (Baseline)]
• Change in Clinical Global Impression- Improvement scale (CGI-I) score between placebo and GyroGlove [Срок оценки: Day-0 (Baseline)]
• Change in Patient Global Impression- Improvement scale (PGI-I) score between placebo and GyroGlove [Срок оценки: Day-0 (Baseline)]
• Percentage of participants with Investigational devices-related adverse events as assessed by CTCAE v4.0 [Срок оценки: 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 [Срок оценки: Day-0 (Baseline) and 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 [Срок оценки: 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 [Срок оценки: Day-0 (Baseline) and Day-14 (follow-up)]
• 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. [Срок оценки: Day-0 (Baseline) and Day-14 (follow-up)]
• Change in EQ-5D-5L score between baseline and follow-up assessment in ET participants [Срок оценки: 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 [Срок оценки: Day-1 to Day-14]
• Change in Clinical Global Impression- Improvement scale (CGI-I) score between baseline and follow-up assessment in ET participants [Срок оценки: Day-0 (Baseline) and Day-14 (follow-up)]
• Change in participants' experience of GyroGlove after 2-week intervention [Срок оценки: Day-14 (follow-up)]

Критерии участия

Критерии включения

• 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

And

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Великобритания · 4 центра

• Addenbrooke Hospital, Cambridge University Hospital NHS Trust — Cambridge
• Clinical Ageing Research Unit, Newcastle University — Newcastle
• Oxford University Hospitals NHS Foundation Trust, UK — Oxford
• North Tyneside General Hospital — Newcastle

США · 3 центра

• Quest Research Institute — Farmington Hills
• Houston Methodist Stanley H. Appel Department of Neurology — Houston
• University of Vermont Medical Centre — Burlington

Идентификаторы

NCT: NCT05958030 · CLIN-0001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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