CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 17 enrolled
Drug / intervention
Responsive deep brain stimulationdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03051178
NCT03051178N/ACompleted

Wearable Sensor Driven Closed-loop Deep Brain Stimulation for Essential Tremor

University of Florida·interventional·Posted Feb 13, 2017·Updated Apr 19, 2024

In Brief

A clinical study evaluating Responsive deep brain stimulation for Essential Tremor. Completed, enrolled 17 participants across 2 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 13, 2017
Enrollment StartSep 18, 2018
Primary CompletionSep 29, 2021
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 9.4 years ago

Interventions

Responsive deep brain stimulationdevice

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.