Assessment of a Novel NeuroAI-powered Transcutaneous Neuromodulation Device in Alleviating Tremor Symptoms and Enhancing Quality of Life for Patients With Upper Limb Essential Tremor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 125
- 试验地点
- 21
- 主要终点
- Change in Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) modified Activities of Daily Living (mADL) score from baseline pre-stimulation to Day 90
研究概览
简要总结
The goal of this clinical study is to compare Felix NeuroAI Wristband and sham device in patients with essential tremor. The main question it aims to answer is:
• Is Felix a safe and efficacious treatment for patients with essential tremor?
Participants will be treated with either Felix or Sham for a period of up to 90 days. After that, they will be eligible to participate in a long-term, open-label study and be treated with Felix.
详细描述
The TRANQUIL study is a prospective, randomized, sham-controlled, double-blinded, multi-center, multi-region trial. The objective of this clinical investigation is to evaluate the safety and effectiveness of the Felix NeuroAI Wristband to aid in the relief of upper limb tremor in adults with essential tremor (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
- Double (Participant, 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
- 否
入选标准
- •At least 18 years of age.
- •Willing to provide written, informed consent to participate in the study.
- •A clinical diagnosis of ET by a movement disorder specialist.
- •For the dominant hand, a tremor severity score of 2 or higher as measured by one of the TETRAS Performance Subscale (PS) tasks (items 4, 6, 7, and 8) and a total score of 7 or higher across these items. If applicable, this must be met while the patient is on ET treatment.
- •Stable dosage of anti-tremor medications, if applicable, for 30 days prior to study entry.
- •Stable dosage of antidepressant medications, if applicable, for 90 days prior to study entry.
- •Familiar with operating a touch-screen smartphone and connecting to Wi-Fi internet at home.
- •If necessary, have a dedicated caregiver to help with study required activities, such as putting on the study device, etc.
- •Willing to comply with study protocol requirements including:
- •Remaining on a stable dosage of anti-tremor and antidepressant medications, if applicable, during the course of the study.
- •Do not start any new anti-tremor treatment during the course of the study (except the assigned treatment in the study).
- •Remaining on stable caffeine consumption, if applicable, during the course of the study.
- •No alcohol or marijuana consumption the day before a study visit.
- •Do not share study/device-related information on the internet or with other study patients.
排除标准
- •Prior limb amputation or any known symptomatic peripheral neuropathy condition of the involved upper extremity.
- •Prior surgical intervention for ET such as deep brain stimulation or thalamotomy.
- •Moderate to severe alcohol use disorder (AUD) as per Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) (the presence of at least 4 symptoms or more).
- •Any current drug abuse.
- •Use of recreational drugs other than marijuana.
- •Current unstable epileptic conditions with a seizure within 6 months of study entry.
- •Other possible causes of tremor such as drug-induced tremor, enhanced physiological tremor, dystonia, and Parkinson's disease.
- •Pregnant or nursing subjects and those who plan pregnancy during the course of the study.
- •Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at the stimulation site.
- •Known allergy to adhesive bandages.
- •The presence of any cognitive or other impairment that in the judgement of the investigator will impede the assessment of study outcomes.
- •Botulinum Toxin injection for hand tremor within 4 months prior to study enrollment.
- •History of use of other transcutaneous afferent patterned stimulation (TAPS) devices such as Cala Trio.
- •Subject is currently participating or has participated in another interventional clinical trial in the last 30 days which may confound the results of this study, unless approved by the Sponsor.
- •Subject is unable to communicate with the investigator and study staff.
- •Any health condition that in the investigator's opinion should preclude participation in this study.
研究组 & 干预措施
Felix NeuroAI Wristband
干预措施: Felix NeuroAI Wristband (Device)
Sham Device
干预措施: Sham Device (Device)
结局指标
主要结局
Change in Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) modified Activities of Daily Living (mADL) score from baseline pre-stimulation to Day 90
时间窗: 90 days
TETRAS mADL score is a composite sum of items 2 to 11 of the TETRAS ADL subscale and items 6 (bilateral) and 7 (dominant hand) of the TETRAS performance subscale (PS). Each item is scored from 0 to 4, indicating increasing severity of tremor. TETRAS mADL score is calculated as the sum of all 12 items and ranges from 0 to 52.
Change in Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) Modified Activities of Daily Living (mADL) Score From Baseline Pre-stimulation to Day 90
时间窗: 90 days
TETRAS mADL score is a composite sum of items 2 to 11 of the TETRAS ADL subscale and items 6 (bilateral) and 7 (dominant hand) of the TETRAS performance subscale (PS). Each item is scored from 0 to 4, indicating increasing severity of tremor. TETRAS mADL score is calculated as the sum of all 13 items and ranges from 0 to 52.
次要结局
- Patient Global Impression of Severity (PGI-S)(Baseline, 14 days, 30 days, 60 days, 90 days, 180 days, and 1 year.)
- Change in Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) modified Activities of Daily Living (mADL) score from baseline pre-stimulation to 14 days, 30 days, 60 days, 180 days, and 1 year(14 days, 30 days, and 60 days, 180 days, and 1 year)
- Responder Rate(14 days, 30 days, 60 days, 90 days, 180 days, and 1 year.)
- Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) performance subscale (PS) Items 1, 4, and 8(Baseline, 30 days, 90 days, and 1 year)
- Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) performance subscale (PS) Dominant Hand Score(Baseline, 30 days, 90 days, and 1 year)
- Clinical Global Impression of Severity (CGI-S)(Baseline, 30 days, 90 days, and 1 year)
- Clinical Global Impression of Improvement (CGI-I)(Baseline, 30 days, 90 days, and 1 year)
- Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) performance subscale (PS) Items 6 and 7(Baseline,14 days, 30 days, 60 days, 90 days, 180 days, and 1 year.)
- Patient Global Impression of Improvement (PGI-I)(Baseline, 14 days, 30 days, 60 days, 90 days, 180 days, and 1 year.)
- Quality of Life in Essential Tremor Questionnaire (QUEST)(Baseline, 90 days, and 1 year)
- Tremor power(Continuously measured up to 1 year)
- Patient survey(14 days, 30 days, 60 days, 90 days, 180 days, and 1 year)
- Change in Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) Modified Activities of Daily Living (mADL) Score From Baseline Pre-stimulation to 14 Days, 30 Days, 60 Days(14 days, 30 days, and 60 days)
- Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) Performance Subscale (PS) Dominant Hand Score(Baseline, 30 days, and 90 days)
- Clinical Global Impression of Severity (CGI-S)(Baseline, 30 days, and 90 days)
- Patient Global Impression of Severity (PGI-S)(Baseline, 14 days, 30 days, 60 days, and 90 days)
- Clinical Global Impression of Improvement (CGI-I)(Baseline, 30 days, and 90 days)
- Patient Global Impression of Improvement (PGI-I)(Baseline, 14 days, 30 days, 60 days, and 90 days)
- Quality of Life in Essential Tremor Questionnaire (QUEST)(Baseline and 90 days)