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Trial record 19 of 121 for:    "Benign essential tremor syndrome"

Cala ONE Device for Essential Tremor

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ClinicalTrials.gov Identifier: NCT02629614
Recruitment Status : Completed
First Posted : December 14, 2015
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Cala Health, Inc.

Brief Summary:
This study evaluates the safety and effectiveness of the Cala ONE device to aid in the symptomatic relief of hand tremors in adult essential tremor subjects. This study is a prospective, randomized, double-blinded, sham-controlled study.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter Study of Safety and Effectiveness of Cala ONE Device for Essential Tremor
Study Start Date : April 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tremor

Arm Intervention/treatment
Experimental: TAPS Stimulation
Temporal Afferent Patterned Stimulation (TAPS) is alternating bursts of TENS stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device.
Device: Cala ONE Device
The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes.

Sham Comparator: Sham Stimulation
0 amplitude stimulation applied to the radial and median nerves of a subject's wrist using the Cala ONE device.
Device: Cala ONE Device
The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes.




Primary Outcome Measures :
  1. Change in TETRAS spiral rating after stimulation [ Time Frame: Immediately before and after 40 minute stimulation session ]
    The primary effectiveness variable is the change in tremor severity immediately after the stimulation session compared to baseline (immediately prior to stimulation) as measured using the TETRAS Archimedes spiral task (assessed by 3 blinded raters).


Secondary Outcome Measures :
  1. Change in TETRAS spiral rating during stimulation [ Time Frame: Immediately before and 30 minutes into stimulation session ]
    An additional analysis variable is the change in tremor severity during the stimulation session (30 minutes into stimulation session) compared to baseline (immediately prior to stimulation) as measured using the TETRAS Archimedes spiral task (assessed by 3 blinded raters).

  2. Self-report improvement [ Time Frame: Immediately before and after 40 minute stimulation session ]
    The proportion of subjects in the treatment group indicating improvement on the CGI-I Scale will be compared to the sham group


Other Outcome Measures:
  1. Change in kinetic tremor [ Time Frame: Immediately before and after 40 minute stimulation session ]
    The change in tremor severity on the kinetic tremor task as assessed by an investigator using the TETRAS rating scale.

  2. Change in kinetic tremor [ Time Frame: Immediately before and 30 minutes into stimulation session ]
    The change in tremor severity on the kinetic tremor task as assessed by an investigator using the TETRAS rating scale.

  3. Change in lateral "wing beating" postural tremor [ Time Frame: Immediately before and after 40 minute stimulation session ]
    The change in tremor severity in the lateral "wing beating" postural tremor task as assessed by an investigator using the TETRAS rating scale.

  4. Change in lateral "wing beating" postural tremor [ Time Frame: Immediately before and 30 minutes into stimulation session ]
    The change in tremor severity in the lateral "wing beating" postural tremor task as assessed by an investigator using the TETRAS rating scale.

  5. Change in forward outstretched postural tremor [ Time Frame: Immediately before and after 40 minute stimulation session ]
    The change in tremor severity on outstretched tremor task as assessed by an investigator using the TETRAS rating scale.

  6. Change in forward outstretched postural tremor [ Time Frame: Immediately before and 30 minutes into stimulation session ]
    The change in tremor severity on outstretched tremor task as assessed by an investigator using the TETRAS rating scale.

  7. Change in Bain & Findley ADL: Use a spoon to drink liquid [ Time Frame: Immediately before and after 40 minute stimulation session ]
    The change in tremor severity on drinking liquid with a spoon as assessed by the subject using the Bain & Findey ADL rating scale

  8. Change in Bain & Findley ADL: Hold a cup of liquid [ Time Frame: Immediately before and after 40 minute stimulation session ]
    The change in tremor severity on holding a cup of liquid as assessed by the subject using the Bain & Findey ADL rating scale

  9. Change in Bain & Findley ADL: Pouring [ Time Frame: Immediately before and after 40 minute stimulation session ]
    The change in tremor severity on pouring as assessed by the subject using the Bain & Findey ADL rating scale

  10. Change in Bain & Findley ADL: Dialing [ Time Frame: Immediately before and after 40 minute stimulation session ]
    The change in tremor severity on dialing a telephone as assessed by the subject using the Bain & Findey ADL rating scale

  11. Change in Bain & Findley ADL: Picking up change [ Time Frame: Immediately before and after 40 minute stimulation session ]
    The change in tremor severity on picking up change as assessed by the subject using the Bain & Findey ADL rating scale

  12. Change in Bain & Findley ADL: Inserting plug into socket [ Time Frame: Immediately before and after 40 minute stimulation session ]
    The change in tremor severity on inserting a plug into a socket as assessed by the subject using the Bain & Findey ADL rating scale

  13. Change in Bain & Findley ADL: Unlocking [ Time Frame: Immediately before and after 40 minute stimulation session ]
    The change in tremor severity on unlocking a lock with a key as assessed by the subject using the Bain & Findey ADL rating scale



Information from the National Library of Medicine

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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:

  1. 22 years or older
  2. A diagnosis of essential tremor as confirmed from clinical history and examination by a movement disorder neurologist
  3. Signed informed consent
  4. At least one hand exhibiting kinetic tremor ≥ 2 as assessed by the TETRAS Archimedes spiral task completed during the baseline evaluation, as assessed by the Investigator in-person.
  5. Score of 3 or above in any one of the items of the Bain & Findley ADL Scale

Exclusion Criteria:

  1. Implanted electrical medical device, such as a pacemaker, defibrillator, or deep brain stimulator
  2. Previous thalamotomy procedure, including Stereotactic Thalamotomy, Gamma Knife Radiosurgical Thalamotomy, and focused ultrasound, for the treatment of tremor
  3. Suspected or diagnosed epilepsy or other seizure disorder
  4. Pregnant
  5. Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at stimulation site
  6. Peripheral neuropathy affecting the tested upper extremity
  7. Alcoholism (score of 4 or higher on DSM-5)
  8. Other possible causes of tremor, including Parkinson's disease, drug-induced, enhanced physiological tremor, dystonia
  9. Other neurodegenerative disease like Parkinson-plus syndromes suspected on neurological examination. These include: multisystem atrophy, progressive supranuclear palsy, dementia with Lewy bodies, and cortical basal ganglionic degeneration
  10. Changes in medication for tremor within 1 month prior to study enrollment
  11. Change in antidepressant medication within 3 months prior to study enrollment
  12. Botulinum Toxin injection for hand tremor within 6 months prior to study enrollment
  13. Current participation in any other interventional research study
  14. Previous participation in any other Cala Health interventional research study
  15. Alcohol or caffeine consumption within 12 hours of study enrollment

Subjects already taking medications for their essential tremor will remain on their medications during the study with no changes in medication type or dosage levels.


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): NCT02629614


Locations
United States, California
UCSF
San Francisco, California, United States, 94121
The Parkinson's Institute
Sunnyvale, California, United States, 94085
United States, Kansas
Kansas University Medical Center
Kansas City, Kansas, United States, 66103
United States, Washington
Swedish Medical Center Seattle
Seattle, Washington, United States, 98122
Sponsors and Collaborators
Cala Health, Inc.
Investigators
Study Chair: Lin, MD Clinical Advisor

Responsible Party: Cala Health, Inc.
ClinicalTrials.gov Identifier: NCT02629614     History of Changes
Other Study ID Numbers: ET-03
First Posted: December 14, 2015    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