Prospective Study for Symptomatic Relief of ET With Cala Therapy

Essential Tremor Clinical Trial

— PROSPECT  

Official title:

Prospective Study for Symptomatic Relief of Essential Tremor With Cala Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03597100
• Other study ID #: ET-14
• Status: Completed
• Phase: N/A
• Start date: December 14, 2018
• Est. completion date: May 29, 2019

Study information

• Verified date: October 2023
• Source: Cala Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 263
• Est. completion date: May 29, 2019
• Est. primary completion date: May 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Essential Tremor
• Tremor

Intervention

Device:
• Cala TWO
Wrist-worn stimulator which applies a tremor-customized stimulation pattern to an individual's nerves

Locations

Country	Name	City	State
United States	Augusta University	Augusta	Georgia
United States	Swedish	Bellevue	Washington
United States	Parkinson's Center	Boca Raton	Florida
United States	Deaconess Medical Center	Boston	Massachusetts
United States	Rush University Medical Center	Chicago	Illinois
United States	River Hills Neuroscience	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	University of Texas Southwestern	Dallas	Texas
United States	Rocky Mountain Movement Disorders Center	Denver	Colorado
United States	Duke University	Durham	North Carolina
United States	Medstar Gerogetown Health Institute	Georgetown	District of Columbia
United States	Texas Movement Disorder Specialist	Georgetown	Texas
United States	Advanced Neurology Specialists	Great Falls	Montana
United States	Houston Methodist	Houston	Texas
United States	Kansas University Medical Center	Kansas City	Kansas
United States	EvergreenHealth Medical Center	Kirkland	Washington
United States	Kaiser Mid-Atlantic Group	Largo	Maryland
United States	Parkinson's Disease and Movement Disorders Center of Long Island	Long Island City	New York
United States	USC	Los Angeles	California
United States	Parkinson's Institute and Clinical Center	Mountain View	California
United States	Hospital for Special Care	New Britain	Connecticut
United States	Mount Sinai & Beth Isreal	New York	New York
United States	Jefferson University	Philadelphia	Pennsylvania
United States	University Of Pennsylvania Medicine	Philadelphia	Pennsylvania
United States	Barrow Neurological Institute (Dignity Health)	Phoenix	Arizona
United States	Wake Forest	Raleigh	North Carolina
United States	Mayo Clinic	Rochester	Minnesota
United States	Central Texas Neurology Consultants	Round Rock	Texas
United States	University of California San Francisco	San Francisco	California
United States	Pacific Neuroscience Institute	Santa Monica	California
United States	USF	Tampa	Florida
United States	Henry Ford Health System	West Bloomfield	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Cala Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TRG (Tremor Research Group) Essential Tremor Rating Assessment Scale (TETRAS) Subset Score	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.	Baseline to 3-months
Primary	Bain & Findley Activities of Daily Living (ADL) Scale Subset Score	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.	Baseline to 3-months
Secondary	Kinematic Measurements, as Collected With the Device During Postural Holds, Change From Pre-stimulation to Post-stimulation Across Sessions	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.	Average change in tremor power over 3-month study period