NCT02947841

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 28, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

September 21, 2018

Status Verified

September 1, 2018

Enrollment Period

8 months

First QC Date

October 24, 2016

Last Update Submit

September 19, 2018

Conditions

Essential TremorDeep Brain Stimulation

Outcome Measures

Primary Outcomes (1)

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

    Through study completion, 12 weeks

Secondary Outcomes (2)

  • Change in TETRAS ADLs scale at 12 weeks

    Through study completion, at 12 weeks

  • Motion sensor data to detect tremor

    Two weeks after initial visit; and again at weeks 10-12

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Treatment

ACTIVE COMPARATOR

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

Other: Alternating stimulation

Interventions

Alternating stimulationOTHER

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.

Treatment
PlaceboOTHER

The control cohort will receive Setting A but Setting B will be identical to Setting A.

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health Science and University

Portland, Oregon, 97239-3098, United States

Location

Related Publications (5)

  • 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.

    PMID: 24096713BACKGROUND

  • 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.

    PMID: 20927533BACKGROUND

  • 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.

    PMID: 19911883BACKGROUND

  • 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.

    PMID: 23582712BACKGROUND

  • 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.

    PMID: 18826350BACKGROUND

MeSH Terms

Conditions

Essential Tremor

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Shannon D Anderson, MPAS, PA-C

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Movement Disorders Physician Assistant

Study Record Dates

First Submitted

October 24, 2016

First Posted

October 28, 2016

Study Start

October 1, 2016

Primary Completion

June 1, 2017

Study Completion

July 1, 2017

Last Updated

September 21, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)