Clinical trial NCT03597100: Prospective Study for Symptomatic Relief of ET With Cala Therapy
Official title: Prospective Study for Symptomatic Relief of Essential Tremor With Cala Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Essential Tremor
Lead sponsor: Cala Health, Inc.
Sponsor class: INDUSTRY
First posted: 2018-07-24
Enrollment: 263
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Must be ≥22 years of age
* Competent and willing to provide written, informed consent to participate in the study
* 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
* 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)
* 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 prior to study visits
  * no usage of the Cala TWO device within 8 hours prior to study visits

Exclusion Criteria:

* 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

Primary outcomes:
measure: TRG (Tremor Research Group) Essential Tremor Rating Assessment Scale (TETRAS) Subset Score
timeFrame: Baseline to 3-months
measure: Bain & Findley Activities of Daily Living (ADL) Scale Subset Score
timeFrame: Baseline to 3-months
Secondary outcomes:
measure: Kinematic Measurements, as Collected With the Device During Postural Holds, Change From Pre-stimulation to Post-stimulation Across Sessions
timeFrame: Average change in tremor power over 3-month study period
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute (Dignity Health)
state: Arizona
city: Los Angeles
country: United States
facility: USC
state: California
city: Mountain View
country: United States
facility: Parkinson's Institute and Clinical Center
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Santa Monica
country: United States
facility: Pacific Neuroscience Institute
state: California
city: Denver
country: United States
facility: Rocky Mountain Movement Disorders Center
state: Colorado
city: New Britain
country: United States
facility: Hospital for Special Care
state: Connecticut
city: Georgetown
country: United States
facility: Medstar Gerogetown Health Institute
state: District of Columbia
city: Boca Raton
country: United States
facility: Parkinson's Center
state: Florida
city: Tampa
country: United States
facility: USF
state: Florida
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Largo
country: United States
facility: Kaiser Mid-Atlantic Group
state: Maryland
city: Boston
country: United States
facility: Deaconess Medical Center
state: Massachusetts
city: West Bloomfield
country: United States
facility: Henry Ford Health System
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Great Falls
country: United States
facility: Advanced Neurology Specialists
state: Montana
city: Long Island City
country: United States
facility: Parkinson's Disease and Movement Disorders Center of Long Island
state: New York
city: New York
country: United States
facility: Mount Sinai & Beth Isreal
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Raleigh
country: United States
facility: Wake Forest
state: North Carolina
city: Cincinnati
country: United States
facility: River Hills Neuroscience
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: University Of Pennsylvania Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: Jefferson University
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
city: Georgetown
country: United States
facility: Texas Movement Disorder Specialist
state: Texas
city: Houston
country: United States
facility: Houston Methodist
state: Texas
city: Round Rock
country: United States
facility: Central Texas Neurology Consultants
state: Texas
city: Bellevue
country: United States
facility: Swedish
state: Washington
city: Kirkland
country: United States
facility: EvergreenHealth Medical Center
state: Washington
Study officials:
References: