Cala TWO Device: Clinical Efficacy and Effects on Regional Brain Metabolism in Essential Tremor Subjects Scheduled to Undergo Deep Brain Stimulation Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Assessment of Tremor Severity Following Transcutaneous Stimulation
研究概览
简要总结
Essential tremor (ET) is the most common movement disorder in the United States and affects up to 5% of the population. ET patients experience involuntary shaking of the hands, head and/or voice that can range from mildly limiting to severely disabling.
Treatment options are limited and there are currently no medications specifically designed to treat it, and medications that are prescribed to relieve tremors are often limited by either inadequate efficacy or intolerable side effects. A subset of essential tremor patients whose tremors are inadequately treated by medication choose to undergo deep brain stimulation (DBS) of the ventral intermediate thalamic nucleus. DBS has been shown to be highly effective for tremor suppression. However, DBS carries significant risks. As a result, a very small (less than 3%) percentage of essential tremor patients undergo DBS therapy.
The medical technology company Cala Health has developed a wristband device (the Cala TWO) that offers individuals with essential tremor a novel non-pharmacological, non-invasive alternative, in the form of stimulation of peripheral nerves, to aid in hand tremor relief. This innovative form of therapy has the potential to have important health, quality of life, and economic benefits for essential tremor patients.
The present pilot study (Aim 1) will assess the effectiveness of 3-month twice daily treatment with the Cala TWO device to aid in the relief of hand tremors in adult essential tremor subjects that have been approved to undergo deep brain stimulation surgery at Mayo Clinic - Rochester. This study is a prospective, within subject, non-significant risk study at Mayo Clinic - Rochester, enrolling approximately 20 subjects.
A completely optional component of this study (Aim 2) is seeking to perform three standard PET/CT sessions on a subset of these subjects (n=10) at Mayo Clinic - Rochester to evaluate changes in brain metabolic activity as a result of 3 months treatment with the device. The first session would take place upon a subjects entry into the study (start of month 1) and prior to any treatment with the Cala device, a second the following day after a 40 minute treatment period with the Cala device, and a third session at the end of the third month. This study is a prospective, within subject, greater than minimum risk study.
详细描述
Hypothesis:
The primary research question is whether customized patterned transcutaneous afferent electrical stimulation to the median and radial nerves via the Cala TWO wrist-band device significantly reduces hand tremors in individuals diagnosed with essential tremor that have been approved as candidates for deep brain stimulation (DBS) surgery. A second research question is whether three months of treatment with the Cala TWO device leads to significant changes in regional brain metabolism that is associated with therapeutic efficacy.
Aims, purpose, or objectives:
Aim 1: Determine the clinical efficacy of the Cala TWO device to transiently reduce hand tremors in the treated hand of subjects with essential tremor (n=20) over a three month treatment period prior to their undergoing DBS surgery for treatment of essential tremor at Mayo Clinic.
Aim 2: Compare regional brain metabolism between baseline, after acute stimulation with the Cala TWO device, and at exit 3 months after therapeutic treatment with the Cala TWO device. 18Ffluorodeoxyglucose (FDG) Positron Emission Tomography (PET)/Computerized Tomography (CT) scans will be applied in a subset (n=10) of essential tremor subjects to evaluate changes in brain tissue metabolic activity corresponding to regional glucose uptake.
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
盲法说明
No other parties will be masked
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject population (children, adults, groups): Adults approved for DBS surgery at Mayo Clinic for treatment of essential tremor
- •Inclusion Criteria:
- •Prospective subjects must meet all of the following criteria to be eligible for study participation:
- •Must be greater than or equal to 21 years of age. Must be approved for DBS surgery at Mayo Clinic for treatment of essential tremor.
- •Competent and willing to provide signed, informed consent to participate in the study.
- •Stable dose of tremor medications, if applicable, for 30 days prior to study entry.
- •Stable dose of antidepressant medications, if applicable, for 90 days prior to study entry.
- •Willing to comply with study protocol requirements including: remaining on a stable dosage of tremor and antidepressant medications, if applicable, during the duration of the study; no significant alcohol or caffeine consumption within 8 hours of study visits; no usage of the Cala TWO device within 8 hours of study visits.
排除标准
- •Prospective subjects that meet any of the following criteria are not eligible for enrollment in this study:
- •Moderate to severe ethanol dependence as defined by the criteria outlined in the DSM-5 (score of 4 or higher).
- •Implanted electrical medical device, such as a pacemaker, defibrillator, or deep brain stimulator.
- •Previous thalamotomy procedure, including stereotactic thalamotomy, gamma knife radiosurgical thalamotomy, and focused ultrasound for the treatment of tremor.
- •Suspected or diagnosed epilepsy or other seizure disorder. Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at stimulation site (wrist).
- •Peripheral neuropathy affecting the tested upper extremity. Presence of any other neurodegenerative disease like Parkinson plus syndromes suspected on neurological examination. These include: multisystem atrophy, progressive supranuclear palsy, dementia with Lewy bodies, and Alzheimer's disease.
- •Anyone suspected to have the diagnosis of idiopathic Parkinson's disease (PD). This includes excluding anyone with the presence of parkinsonian features including bradykinesia rigidity, or postural instability. Subjects that exhibit only mild resting tremor but no other symptoms or signs of PD may be included.
- •Botulinum toxin injection for hand tremor within 6 months prior to study enrollment.
- •Are participating or have participated in another interventional clinical trial in the last 30 days which may confound the results of this study, unless approved by the Principal Investigator.
- •Significant alcohol or caffeine consumption within 8 hours of study enrollment, which may confound the results of the study, where significant caffeine is considered more than 95 mg (equivalent to a cup of coffee), and significant alcohol is considered more than 14 g (equivalent to 5 oz of wine, 12 oz of beer, or 1.5 oz of distilled spirits).
- •Subjects unable to communicate with the investigator and staff. Any health condition that in the investigator's opinion should preclude participation in this study.
- •Pregnancy or anticipated pregnancy during the course of the study.
研究组 & 干预措施
Transcutaneous stimulation
Participants in the clinical study will consist of subjects with essential tremor who are scheduled more than 3 months in advance to undergo deep brain stimulation surgery for treatment of essential tremor at Mayo Clinic. Subjects will wear a Cala TWO stimulator to reduce hand tremors.
干预措施: Cala TWO stimulator (Device)
结局指标
主要结局
Assessment of Tremor Severity Following Transcutaneous Stimulation
时间窗: Patient assessed at entry to study and at exit of study (3 months).
• The Patient Global Impression - Severity scale (PGI-S) on tremor mean improvement change across pre- and post-stimulation sessions. The PGI-S will be a 7-point scale that the participant will use to assess their overall tremor severity of the stimulated hand and consists of: 1 = Normal ; 2 = Hardly perceptible ; 3 = Mild ; 4 = Moderate ; 5 = Marked ; 6 = Severe ; 7 = Extreme
Essential Tremor Assessment Following Transcutaneous Stimulation
时间窗: Patient assessed at entry to study and at exit of study (3 months).
• The Essential Tremor Rating Assessment Scale (TETRAS) - dominant hand subset mean change (pre-stimulation rating - post-stimulation rating) across visits. Upper limb tremor will be assessed during three maneuvers: forward horizontal reach posture, lateral "wing beating" posture and finger-nose-finger testing. Each upper limb will be assessed and scored individually according to the following scale: 0 = no tremor ; 1 = tremor is barely visible ; 1.5 = tremor is visible, but less than 1 cm ; 2 = tremor is 1- less than 3 cm amplitude ; 2.5 = tremor is 3- less than 5 cm amplitude ; 3 = tremor is 5- less than 10 cm amplitude ; 3.5 = tremor is 10- less than 20 cm amplitude ; 4 = tremor is less than 20 cm amplitude
Assessment of Daily Activities Following Transcutaneous Stimulation
时间窗: Patient assessed at entry to study and at exit of study (3 months).
• Bain \& Findley Activities of Daily Living (ADL) Scale (pre-stimulation rating - poststimulation rating) across visits. ADL tasks are: Use a spoon to drink soup ; Hold a cup of tea ; Pour milk from a bottle or carton ; Dial a telephone ; Pick up your change in a shop ; Insert an electric plug into a socket ; Unlock your front door with a key. Each task will be rated on a 4-point scale (1-4): 1 = Able to do the activity without difficulty ; 2 = Able to do the activity with a little effort ; 3 = Able to do the activity with a lot of effort ; 4 = Cannot do the activity by yourself
次要结局
- Daily Changes in Tremor over 3 Months of Transcutaneous Stimulation(Patient assessed at entry to study, twice daily over the course of 3 months, and at exit of study (3 months).)