Prospective Study for Symptomatic Relief of ET With Cala Therapy (PROSPECT)
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|ClinicalTrials.gov Identifier: NCT03597100|
Recruitment Status : Completed
First Posted : July 24, 2018
Last Update Posted : July 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Essential Tremor||Device: Cala TWO||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||263 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
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
|United States, California|
|Los Angeles, California, United States, 90033|
|United States, Florida|
|Tampa, Florida, United States, 33612|