The Effectiveness of Alternating Stimulation in Preventing Tolerance in Essential Tremor Patients (AltStim DBS)

September 19, 2018 updated by: Shannon Anderson, Oregon Health and Science University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239-3098
        • Oregon Health Science and University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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
  2. At least initial benefit from VIM DBS as judged by patient report and clinician exam
  3. VIM DBS placement no less than three months from entry into study
  4. Patients must demonstrate ability to use patient programmer to switch between group settings on a weekly basis
  5. 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

Exclusion Criteria:

  1. Atypical tremor disorder including but not limited to tremor due to multiple sclerosis, medication-induced tremor, Parkinson's disease or parkinsonian syndrome
  2. DBS placement complicated by infection, hemorrhage or stroke
  3. Previous thalamotomy (either stereotactic, gamma knife or focused ultrasound) or previous DBS surgery resulting in explantation and reimplantation
  4. Known incorrect or poor lead placement
  5. Inability to change group settings on a weekly basis at least 75% of the time
  6. Inability to tolerate 12-week period without additional programming changes, including voltage stimulation adjustment
  7. Inability to tolerate 12-week period without adjustment of anti-tremor medications, including primidone, beta-blockers, gabapentin, topiramate and/or benzodiazepines
  8. Battery voltage < or equal to 2.70V
  9. Patient with the following IPG types: Soletra, Kinetra or Itrel
  10. Inability to tolerate two group settings due to side effects or lack of efficacy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: Placebo
The control cohort will receive Setting A but Setting B will be identical to Setting A.
Active Comparator: Treatment
In the treatment cohort, subjects will alternate their DBS parameters between group A and group B every week for 12 weeks.
Other: Alternating stimulation
Two different, but equally efficacious, settings will be determined for each subject. The settings will differ by a minimum of two of the following parameters: electrode configuration, voltage, frequency and pulse width. The different settings will be named Setting A and Setting B. The treatment cohort will receive both Setting A and Setting B that will differ by the parameters listed above.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) performance sub scale at 12 weeks
Time Frame: Through study completion, 12 weeks
Through study completion, 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in TETRAS ADLs scale at 12 weeks
Time Frame: Through study completion, at 12 weeks
Through study completion, at 12 weeks
Motion sensor data to detect tremor
Time Frame: Two weeks after initial visit; and again at weeks 10-12
Patients will wear motion sensor device to detect tremor characteristics
Two weeks after initial visit; and again at weeks 10-12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Investigators

  • Principal Investigator: Shannon D Anderson, MPAS, PA-C, Oregon Health and Science University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

October 24, 2016

First Submitted That Met QC Criteria

October 27, 2016

First Posted (Estimate)

October 28, 2016

Study Record Updates

Last Update Posted (Actual)

September 21, 2018

Last Update Submitted That Met QC Criteria

September 19, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00015871

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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