The Effectiveness of Alternating Ventral Intermediate Nucleus Deep Brain Stimulation Parameters in Preventing Tolerance in Essential Tremor Patients

Status: Completed
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this study is to investigate the hypothesis that alternating DBS parameters on a weekly basis will prevent tolerance to stimulation and thus waning of benefit, compared with non-alternating stimulation. The primary endpoint will be preserved tremor control with the alternating group compared with standard treatment using the Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS). Key secondary endpoints will be preserved activities of daily living measures as well as preserved tremor control as quantified by motion sensor data. This study has one primary aim: To determine if alternating DBS stimulation parameters on a weekly basis will be superior at preserving tremor control compared with usual stimulation (non-alternating stimulation) in ET patients with VIM DBS.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients with clinically diagnosed ET who have had placement of VIM DBS and are willing to undergo a baseline programming visit and 12-week follow-up assessment

• At least initial benefit from VIM DBS as judged by patient report and clinician exam

• VIM DBS placement no less than three months from entry into study

• Patients must demonstrate ability to use patient programmer to switch between group settings on a weekly basis

• Ability to wear wrist monitor for 2 week intervals, twice during the study 6. Patients with the following IPG types: Activa PC, SC or RC

Locations
United States
Oregon
Oregon Health Science and University
Portland
Time Frame
Start Date: 2016-10
Completion Date: 2017-07
Participants
Target number of participants: 22
Treatments
Placebo_comparator: Placebo
In the placebo cohort, subjects will alternate their DBS parameters between group A and group B every week for 12 weeks, but they will be blinded to the fact that their group A and group B are equivalent.
Active_comparator: Treatment
In the treatment cohort, subjects will alternate their DBS parameters between group A and group B every week for 12 weeks.
Sponsors
Leads: Oregon Health and Science University

This content was sourced from clinicaltrials.gov