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Completed

NCT Number: NCT02947841

The Effectiveness of Alternating Stimulation 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.

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Key information

Conditions

Essential Tremor Central Nervous System Diseases Deep Brain Stimulation Movement Disorders Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health Science and University

Portland, Oregon, 97239-3098, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alternating stimulation

Other

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.

Placebo

Other

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

Primary outcomes

  1. 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 outcomes

  1. Change in TETRAS ADLs scale at 12 weeks

    Time frame: Through study completion, at 12 weeks

  2. 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

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

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

Acronym: AltStim DBS

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 28, 2016
Registry last updated
Sep 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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