Boston Scientific Registry of Deep Brain Stimulation for Treatment of Essential Tremor (ET)
ConditionEssential Tremor
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBoston Scientific Corporation
About this trial
To compile characteristics of real-world outcomes for Boston Scientific Corporation's commercially approved Deep Brain Stimulation (DBS) Systems, when used according to the applicable Directions for Use, for the treatment of Essential Tremor.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Meets criteria established in the locally applicable Directions for Use (DFU) for Essential Tremor
Is at least 18 years old
Disqualifiers
Meets any contraindication in locally applicable Directions for Use
Trial population
Subjects with Essential Tremor
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Deep Brain Stimulation Systems (DBS)
DeviceSubjects receiving DBS implant for treatment of Essential Tremor
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: Essential Tremor1 intervention
Trial outcomes
Primary outcomes
1
Change in Quality of Life during the study as compared with baseline using the Quality of Life in Essential Tremor Questionnaire (QUEST)
Change in quality of life over the course of the study using QUEST
Time frame
Up to 3 yearsOther outcomes
1
Change in tremor scores during the study as compared with baseline as assessed by Fahn-Tolosa- Marin Rating Scale
Improvement in tremor scores as assessed by Fahn-Tolosa-Marin Tremor Rating Scale (FTMTRS) during the study as compared with baseline
Time frame
Up to 3 years2
Impression of Change scores during the study using Global Impression of Change
Impression of Change scores during the study using Global Impression of Change
Time frame
Up to 3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov