Prospective Study for Symptomatic Relief of ET With Cala Therapy
- Conditions
- Essential Tremor
- Interventions
- Device: Cala TWO
- Registration Number
- NCT03597100
- Lead Sponsor
- Cala Health, Inc.
- Brief Summary
Prospective, multi-center, single-arm, non-significant risk study designed to evaluate the Cala TWO device. Subjects will be screened for eligibility and fitted with a Cala TWO device. Subjects will wear the device at home for a period of 3 months, during which they will be asked to stimulate their dominant hand twice a day. The stimulation amplitude will be based on each subject's stimulation threshold. Subjects will have in clinic assessments at enrollment, month 1 and 3.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 263
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Must be ≥22 years of age
-
Competent and willing to provide written, informed consent to participate in the study
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A diagnosis of essential tremor as confirmed from clinical history and examination by a movement disorder neurologist
-
A tremor severity score of 2 or above in the dominant hand/arm as measured by any one of the TETRAS upper limb items and a minimum subset score of 6 across all upper limb items
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Significant disability due to essential tremor (Bain & Findley score of 3 or above in any one of the upper limb items and a minimum subset score of 8 across all upper limb items)
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Stable dose of tremor medications, if applicable, for 30 days prior to study entry
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Stable dose of antidepressant medications, if applicable, for 90 days prior to study entry
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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 prior to study visits
- no usage of the Cala TWO device within 8 hours prior to study visits
- 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, or implanted metal in the wrist to be stimulated
- 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
- 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 who 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 Sponsor
- Significant alcohol or caffeine consumption within 8 hours prior to 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cala TWO Cala TWO Two 40-minute stimulation sessions daily, separated by at least two hours
- Primary Outcome Measures
Name Time Method TRG (Tremor Research Group) Essential Tremor Rating Assessment Scale (TETRAS) Subset Score Baseline to 3-months Tremor Research Group (TRG) Essential Tremor Rating Assessment Scale (TETRAS) subset score: TETRAS subset score relevant to the stimulated upper limb. The subset score is the sum of 6 rated tasks. Each task is rated 0 to 4, where a higher score indicates more severe tremor. Minimum subset score = 0; Maximum subset score = 24.
Bain & Findley Activities of Daily Living (ADL) Scale Subset Score Baseline to 3-months Bain \& Findley ADL subset score relevant to the stimulated upper limb. The subset score is the sum of 8 rated tasks. Each task is rated 1 to 4, where a higher score indicates more severe tremor. Minimum subset score = 8; Maximum subset score = 32.
- Secondary Outcome Measures
Name Time Method Kinematic Measurements, as Collected With the Device During Postural Holds, Change From Pre-stimulation to Post-stimulation Across Sessions Average change in tremor power over 3-month study period Subjects will be prompted to perform a postural hold task before and after each stimulation session. During this task, the device will record kinematic data using on-board motion sensors to objectively assess if there are any changes in tremor level. The change in each patient's pre- and post-stimulation tremor power was defined as the median change over all valid stimulation sessions. Sample mean and standard deviations were computed using the median change value from all patients.
Trial Locations
- Locations (32)
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Parkinson's Center
🇺🇸Boca Raton, Florida, United States
Central Texas Neurology Consultants
🇺🇸Round Rock, Texas, United States
Augusta University
🇺🇸Augusta, Georgia, United States
Kansas University Medical Center
🇺🇸Kansas City, Kansas, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
Duke University
🇺🇸Durham, North Carolina, United States
Wake Forest
🇺🇸Raleigh, North Carolina, United States
Barrow Neurological Institute (Dignity Health)
🇺🇸Phoenix, Arizona, United States
USC
🇺🇸Los Angeles, California, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Pacific Neuroscience Institute
🇺🇸Santa Monica, California, United States
Hospital for Special Care
🇺🇸New Britain, Connecticut, United States
Rocky Mountain Movement Disorders Center
🇺🇸Denver, Colorado, United States
USF
🇺🇸Tampa, Florida, United States
Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
River Hills Neuroscience
🇺🇸Cincinnati, Ohio, United States
EvergreenHealth Medical Center
🇺🇸Kirkland, Washington, United States
University of Texas Southwestern
🇺🇸Dallas, Texas, United States
Swedish
🇺🇸Bellevue, Washington, United States
Houston Methodist
🇺🇸Houston, Texas, United States
University Of Pennsylvania Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Texas Movement Disorder Specialist
🇺🇸Georgetown, Texas, United States
Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
Parkinson's Institute and Clinical Center
🇺🇸Mountain View, California, United States
Medstar Gerogetown Health Institute
🇺🇸Georgetown, District of Columbia, United States
Henry Ford Health System
🇺🇸West Bloomfield, Michigan, United States
Kaiser Mid-Atlantic Group
🇺🇸Largo, Maryland, United States
Advanced Neurology Specialists
🇺🇸Great Falls, Montana, United States
Parkinson's Disease and Movement Disorders Center of Long Island
🇺🇸Long Island City, New York, United States
Mount Sinai & Beth Isreal
🇺🇸New York, New York, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States