Wearable Sensor for Responsive DBS for ET
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|ClinicalTrials.gov Identifier: NCT03051178|
Recruitment Status : Completed
First Posted : February 13, 2017
Results First Posted : October 28, 2022
Last Update Posted : November 22, 2022
The purpose of this study is evaluate the effectiveness and safety of a possible new treatment for Essential Tremor (ET) using external wearable sensors, which have the capability of recording acceleration and Electromyography (EMG). This therapy is called Responsive Deep Brain Stimulation (R-DBS). R-DBS systems will communicate with a computer, and apply stimulation when the computer detects patterns associated with tremor. This detection will suppress pathological activity and improve or alleviate the tremor.
Currently, DBS is approved for the treatment of ET; however, stimulation is delivered continuously even when tremor or other symptoms are absent. Continuous DBS can lead to unwanted side effects such as stuttering and gait\balance problems. On the other hand, R-DBS will turn on only if activity associated with ET from the external sensors is detected.
|Condition or disease||Intervention/treatment||Phase|
|Essential Tremor||Device: Responsive deep brain stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Wearable Sensor Driven Closed-loop Deep Brain Stimulation for Essential Tremor|
|Actual Study Start Date :||September 18, 2018|
|Actual Primary Completion Date :||September 29, 2021|
|Actual Study Completion Date :||September 29, 2021|
Experimental: Subjects with Essential Tremor
This cohort will receive deep brain stimulation (DBS) therapy responsively based on the level of their symptoms as detected by wearable EMG and inertia (acceleration) sensors.
Device: Responsive deep brain stimulation
Responsive deep brain stimulation (R-DBS) therapy will be delivered responsively based on the level of their symptoms as detected by wearable EMG and inertia (acceleration) sensors.
- Clinical Rating Scale for Tremor (CRST) [ Time Frame: 30 minutes during one monthly visit after clinical continuous deep brain stimulation is optimized. ]Responsive deep brain stimulation as an effective alternative to continuous deep brain stimulation. Clinical Tremor Rating Scale (TRS), rated by a blinded neurologist, during responsive brain stimulation will be compared to scores during continuous deep brain stimulation and no stimulation. The minimum and maximum score range for this scale is 0-80, with higher score indicating worse outcome.
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): NCT03051178
|United States, Florida|
|Gainesville, Florida, United States, 32610|
|Biomedical Sciences Building|
|Gainesville, Florida, United States, 32611|
|Principal Investigator:||Aysegul Gunduz, PhD||University of Florida|