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Prospective Study for Symptomatic Relief of ET With Cala Therapy (PROSPECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03597100
Recruitment Status : Completed
First Posted : July 24, 2018
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Essential Tremor Device: Cala TWO Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 263 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Study for Symptomatic Relief of Essential Tremor With Cala Therapy
Actual Study Start Date : December 14, 2018
Actual Primary Completion Date : May 29, 2019
Actual Study Completion Date : May 29, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cala TWO
Two 40-minute stimulation sessions daily, separated by at least two hours
Device: Cala TWO
Wrist-worn stimulator which applies a tremor-customized stimulation pattern to an individual's nerves




Primary Outcome Measures :
  1. TRG (Tremor Research Group) Essential Tremor Rating Assessment Scale (TETRAS) subset score [ Time Frame: Baseline to 3-months ]
    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.

  2. Bain & Findley Activities of Daily Living (ADL) scale subset score [ Time Frame: 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 :
  1. Kinematic measurements, as collected with the device during postural holds, change from pre-stimulation to post-stimulation across sessions [ Time Frame: Pre-stimulation and post-stimulation across sessions during 3-month study participation ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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): NCT03597100


Locations
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United States, California
USC
Los Angeles, California, United States, 90033
United States, Florida
USF
Tampa, Florida, United States, 33612
Sponsors and Collaborators
Cala Health, Inc.
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Responsible Party: Cala Health, Inc.
ClinicalTrials.gov Identifier: NCT03597100    
Other Study ID Numbers: ET-14
First Posted: July 24, 2018    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Tremor
Essential Tremor
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Movement Disorders
Central Nervous System Diseases