Long-Term Transcutaneous Stimulation and Essential Tremor: A PET Study
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|ClinicalTrials.gov Identifier: NCT03778060|
Recruitment Status : Recruiting
First Posted : December 19, 2018
Last Update Posted : February 18, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Essential Tremor||Device: Cala TWO stimulator||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||No other parties will be masked|
|Official Title:||Cala TWO Device: Clinical Efficacy and Effects on Regional Brain Metabolism in Essential Tremor Subjects Scheduled to Undergo Deep Brain Stimulation Surgery|
|Actual Study Start Date :||February 11, 2019|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: 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.
Device: Cala TWO stimulator
Treatment intervention will consist of subjects undergoing 40 minute sessions of transcutaneous stimulation with the Cala TWO stimulator twice daily for 3 months to reduce hand tremors prior to their undergoing deep brain stimulation 'surgery for treatment of essential tremor at Mayo Clinic.
- Essential Tremor Assessment Following Transcutaneous Stimulation [ Time Frame: 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 [ Time Frame: 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
- Assessment of Tremor Severity Following Transcutaneous Stimulation [ Time Frame: 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
- Daily Changes in Tremor over 3 Months of Transcutaneous Stimulation [ Time Frame: Patient assessed at entry to study, twice daily over the course of 3 months, and at exit of study (3 months). ]• Kinematic data mean change in units of meters^2/sec (pre-stimulation tremor power - post-stimulation tremor power) across stimulation sessions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03778060
|Principal Investigator:||Kendall H Lee||Mayo Clinic|