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

Primary Purpose

Essential Tremor, Deep Brain Stimulation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alternating stimulation
Placebo
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Tremor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oregon Health Science and University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Treatment

Arm Description

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.

In the treatment cohort, subjects will alternate their DBS parameters between group A and group B every week for 12 weeks.

Outcomes

Primary Outcome Measures

Change from baseline Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) performance sub scale at 12 weeks

Secondary Outcome Measures

Change in TETRAS ADLs scale at 12 weeks
Motion sensor data to detect tremor
Patients will wear motion sensor device to detect tremor characteristics

Full Information

First Posted
October 24, 2016
Last Updated
September 19, 2018
Sponsor
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT02947841
Brief Title
The Effectiveness of Alternating Stimulation in Preventing Tolerance in Essential Tremor Patients
Acronym
AltStim DBS
Official Title
The Effectiveness of Alternating Ventral Intermediate Nucleus Deep Brain Stimulation Parameters in Preventing Tolerance in Essential Tremor Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Tremor, Deep Brain Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Treatment
Arm Type
Active Comparator
Arm Description
In the treatment cohort, subjects will alternate their DBS parameters between group A and group B every week for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Alternating stimulation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
The control cohort will receive Setting A but Setting B will be identical to Setting A.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Change in TETRAS ADLs scale at 12 weeks
Time Frame
Through study completion, at 12 weeks
Title
Motion sensor data to detect tremor
Description
Patients will wear motion sensor device to detect tremor characteristics
Time Frame
Two weeks after initial visit; and again at weeks 10-12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Atypical tremor disorder including but not limited to tremor due to multiple sclerosis, medication-induced tremor, Parkinson's disease or parkinsonian syndrome DBS placement complicated by infection, hemorrhage or stroke Previous thalamotomy (either stereotactic, gamma knife or focused ultrasound) or previous DBS surgery resulting in explantation and reimplantation Known incorrect or poor lead placement Inability to change group settings on a weekly basis at least 75% of the time Inability to tolerate 12-week period without additional programming changes, including voltage stimulation adjustment Inability to tolerate 12-week period without adjustment of anti-tremor medications, including primidone, beta-blockers, gabapentin, topiramate and/or benzodiazepines Battery voltage < or equal to 2.70V Patient with the following IPG types: Soletra, Kinetra or Itrel Inability to tolerate two group settings due to side effects or lack of efficacy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shannon D Anderson, MPAS, PA-C
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health Science and University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24096713
Citation
Baizabal-Carvallo JF, Kagnoff MN, Jimenez-Shahed J, Fekete R, Jankovic J. The safety and efficacy of thalamic deep brain stimulation in essential tremor: 10 years and beyond. J Neurol Neurosurg Psychiatry. 2014 May;85(5):567-72. doi: 10.1136/jnnp-2013-304943. Epub 2013 Oct 4.
Results Reference
background
PubMed Identifier
20927533
Citation
Barbe MT, Liebhart L, Runge M, Pauls KA, Wojtecki L, Schnitzler A, Allert N, Fink GR, Sturm V, Maarouf M, Timmermann L. Deep brain stimulation in the nucleus ventralis intermedius in patients with essential tremor: habituation of tremor suppression. J Neurol. 2011 Mar;258(3):434-9. doi: 10.1007/s00415-010-5773-3. Epub 2010 Oct 8.
Results Reference
background
PubMed Identifier
19911883
Citation
Zhang K, Bhatia S, Oh MY, Cohen D, Angle C, Whiting D. Long-term results of thalamic deep brain stimulation for essential tremor. J Neurosurg. 2010 Jun;112(6):1271-6. doi: 10.3171/2009.10.JNS09371.
Results Reference
background
PubMed Identifier
23582712
Citation
Shih LC, LaFaver K, Lim C, Papavassiliou E, Tarsy D. Loss of benefit in VIM thalamic deep brain stimulation (DBS) for essential tremor (ET): how prevalent is it? Parkinsonism Relat Disord. 2013 Jul;19(7):676-9. doi: 10.1016/j.parkreldis.2013.03.006. Epub 2013 Apr 11.
Results Reference
background
PubMed Identifier
18826350
Citation
Pilitsis JG, Metman LV, Toleikis JR, Hughes LE, Sani SB, Bakay RA. Factors involved in long-term efficacy of deep brain stimulation of the thalamus for essential tremor. J Neurosurg. 2008 Oct;109(4):640-6. doi: 10.3171/JNS/2008/109/10/0640.
Results Reference
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The Effectiveness of Alternating Stimulation in Preventing Tolerance in Essential Tremor Patients

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