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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.

Tracking Information
First Submitted Date  ICMJE June 27, 2018
First Posted Date  ICMJE July 24, 2018
Last Update Posted Date July 23, 2019
Actual Study Start Date  ICMJE December 14, 2018
Actual Primary Completion Date May 29, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2018)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2018)
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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prospective Study for Symptomatic Relief of ET With Cala Therapy
Official Title  ICMJE Prospective Study for Symptomatic Relief of Essential Tremor With Cala Therapy
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Essential Tremor
Intervention  ICMJE Device: Cala TWO
Wrist-worn stimulator which applies a tremor-customized stimulation pattern to an individual's nerves
Study Arms  ICMJE Experimental: Cala TWO
Two 40-minute stimulation sessions daily, separated by at least two hours
Intervention: Device: Cala TWO
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 20, 2019)
263
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 29, 2019
Actual Primary Completion Date May 29, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03597100
Other Study ID Numbers  ICMJE ET-14
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cala Health, Inc.
Study Sponsor  ICMJE Cala Health, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cala Health, Inc.
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP