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Trial record 21 of 121 for:    "Benign essential tremor syndrome"

A Pilot Study of the Cala ONE Device for Essential Tremor (EXCITE)

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ClinicalTrials.gov Identifier: NCT03152136
Recruitment Status : Completed
First Posted : May 12, 2017
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Cala Health, Inc.

Brief Summary:
Prospective, multi-center, randomized, controlled study designed to evaluate safety and repeatable effectiveness. Subjects will be randomized 2:1:1 to transcutaneous afferent patterned stimulation (TAPS), sham, or 'no intervention', respectively. Subjects randomized to the TAPS and sham arms will be blinded to their randomization assignments for the first two weeks of participation (controlled phase). After the first two weeks, all subjects will be crossed over to TAPS (open-label phase) for 2 weeks. During study participation, all subjects are to remain on a stable dosage of medications prescribed for the treatment of essential tremor, if applicable.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The first two weeks are a 3-arm parallel design (treatment, sham, and 'no intervention'). The second two weeks are open-label (all subjects cross-over to treatment arm).
Masking: Double (Participant, Outcomes Assessor)
Masking Description:

The first two weeks of the study are double-blinded for the treatment and sham arms. The subjects and rating movement disorder neurologists will be blinded to the therapy allocation for the treatment and sham arms. The subjects in the 'no intervention' arm and their rating neurologists will not be blinded to their therapy allocation.

The last two weeks are open-label, and all subjects will be given the option to use the Cala ONE device.

Primary Purpose: Treatment
Official Title: A Pilot Study to Evaluate the Safety and Initial Effectiveness of the Cala ONE Device to Repeatably Aid in the Symptomatic Relief of Essential Tremor
Actual Study Start Date : July 26, 2017
Actual Primary Completion Date : March 8, 2018
Actual Study Completion Date : March 8, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tremor

Arm Intervention/treatment
Experimental: TAPS
Subjects will receive a Cala ONE device that delivers TAPS, transcutaneous afferent patterned stimulation.
Device: Cala ONE device
The Cala ONE device is a wrist-worn stimulator which applies a tremor-customized stimulation pattern to an individual's nerves.

Sham Comparator: Sham
Subjects will receive a Cala ONE device that delivers sham stimulation.
Device: Cala ONE device
The Cala ONE device is a wrist-worn stimulator which applies a tremor-customized stimulation pattern to an individual's nerves.

No Intervention: No Intervention
Subjects will not receive a Cala ONE device, and will stay on their current treatment regimen for their essential tremor.



Primary Outcome Measures :
  1. Change in Clinical Rating Scale for Tremor (CRST) after stimulation [ Time Frame: Collected before and after in-office stimulation sessions at Week 2 ]
    A complete CRST examination (also known as the Fahn-Tolosa-Marin Tremor Rating Scale) will be completed at baseline for all arms: TAPS, sham, and 'no intervention.' For TAPS and sham arms, a subset of CRST relevant to upper limb tremor will be repeated after stimulation.


Other Outcome Measures:
  1. Change in Clinical Global Impression of Severity (CGI-S) [ Time Frame: Collected before, during, and after in-office stimulation sessions at Week 0, Week 2, and Week 4 ]
    Tremor severity will be assessed with the 7-point CGI-S scale at baseline for all arms. For TAPS and sham arms, CGI-S will also be assessed during and after stimulation.

  2. Clinical Global Impression of Improvement (CGI-I) [ Time Frame: Collected during and after in-office stimulation sessions at Week 0, Week 2, and Week 4 ]
    For TAPS and sham arms, the blinded rating neurologist will assess improvements in tremor level during and after stimulation.

  3. Change in Bain & Findley Activities of Daily Living (ADL) Scale [ Time Frame: Collected before, during, and after in-office stimulation sessions at Week 0, Week 2, and Week 4. Collected via phone call Week 1 and Week 3. ]

    The complete Bain & Findley ADL questionnaire will be administered at baseline for all arms. For TAPS and sham arms, a subset of ADLs relevant to upper limb tremor will be repeated with provided props during and after stimulation.

    On a weekly basis, all subjects will answer the complete Bain & Findley ADL questionnaire via phone call.


  4. Subject Impression of Durability of Effect [ Time Frame: Week 1, 2, 3 and 4. ]
    TAPS and sham arms will also be asked how long their tremor relief lasts due to stimulation, if applicable.

  5. Change in Quality of life in Essential Tremor Questionnaire (QUEST) [ Time Frame: Week 0, 2, and 4 ]
    The QUEST assessment will be administered to all subjects during in-office visits (every 2 weeks).

  6. Change in Patient Global Impression of Severity (PGI-S) [ Time Frame: Before and after every stimulation session for TAPS and sham subjects through study completion. Twice daily for 'no intervention' subjects through study completion. ]

    Tremor severity will be assessed with the 7-point PGI-S scale at baseline for all arms. For TAPS and sham arms, PGI-S will also be assessed during and after stimulation during office visits.

    Additionally, for TAPS and sham arms, PGI-S will be entered on the device before and after each stimulation session in the home environment.


  7. Patient Global Impression of Improvement (PGI-I) [ Time Frame: Collected during and after in-office stimulation sessions at Week 0, Week 2, and Week 4 ]
    For TAPS and sham arms, the blinded subject will assess improvements in their tremor level during and after stimulation during office visits.

  8. Subject Survey of Satisfaction [ Time Frame: Week 4 ]
    At the final visit, all subject will take a subject satisfaction survey which will include questions such as likelihood to recommend and other questions related to the usability of the device.

  9. Change in Motion Data [ Time Frame: Before and after each stimulation session for TAPS and sham subjects through study completion. ]
    For TAPS and sham arms, subjects will be prompted to perform a lateral postural hold prior to entering their PGI-S score before and after each stimulation session. During this hold, the device will record motion data to objectively assess if there are any changes in tremor level.

  10. Device Usage Metrics [ Time Frame: Week 4 ]
    For TAPS and sham arms, the device will record usage metrics such as how many times the device was used per day and stimulation amplitude, to assess if there are any changes over time within group and within subject.

  11. Change in Clinical Rating Scale for Tremor (CRST) after stimulation [ Time Frame: Collected before and after in-office stimulation sessions at Week 0 and 4. ]
    A complete CRST examination (also known as the Fahn-Tolosa-Marin Tremor Rating Scale) will be completed at baseline for all arms: TAPS, sham, and 'no intervention.' For TAPS and sham arms, a subset of CRST relevant to upper limb tremor will be repeated after stimulation.

  12. Change in Clinical Rating Scale for Tremor (CRST) during stimulation [ Time Frame: Collected before and during in-office stimulation sessions at Week 0, 2 and 4. ]
    A complete CRST examination (also known as the Fahn-Tolosa-Marin Tremor Rating Scale) will be completed at baseline for all arms: TAPS, sham, and 'no intervention.' For TAPS and sham arms, a subset of CRST relevant to upper limb tremor will be repeated during stimulation.



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Ages Eligible for Study:   22 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be ≥22 and ≤80 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
  • Postural, action or intention tremor severity score of 2 or above in the dominant hand/arm as measured by the CRST rating scale
  • Significant disability due to essential tremor (Bain & Findley score of 3 or above in any one of the hand items)
  • Currently or previously prescribed either propranolol or primidone for the treatment of essential tremor
  • Stable dose of tremor medications for 30 days prior to study entry
  • Stable dose of antidepressant medications 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 12 hours of study visits; and no significant alcohol or caffeine consumption within 4 hours of twice-daily at home assessments during the controlled phase of the study

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
  • 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
  • Are participating or have participated in another Cala Health clinical trial
  • Significant alcohol or caffeine consumption within 12 hours of 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): NCT03152136


Locations
United States, California
Personal Care Neurology
Oakland, California, United States, 94611
United States, Colorado
Movement & Neuroperformance Center
Denver, Colorado, United States, 80113
United States, Kansas
Kansas University Medical Center
Kansas City, Kansas, United States, 66103
United States, Washington
EvergreenHealth
Kirkland, Washington, United States, 98034
Sponsors and Collaborators
Cala Health, Inc.

Responsible Party: Cala Health, Inc.
ClinicalTrials.gov Identifier: NCT03152136     History of Changes
Other Study ID Numbers: ET-13
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be published, but no PHI will be made available.

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: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Tremor
Essential Tremor
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases