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Ataxia in Essential Tremor: Describing the Differences Between Disease Process and Treatment Effect (ATAX)

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ClinicalTrials.gov Identifier: NCT03769961
Recruitment Status : Recruiting
First Posted : December 10, 2018
Last Update Posted : December 18, 2018
Sponsor:
Collaborator:
Portland VA Medical Center
Information provided by (Responsible Party):
Amie Hiller, MD, Oregon Health and Science University

Tracking Information
First Submitted Date December 6, 2018
First Posted Date December 10, 2018
Last Update Posted Date December 18, 2018
Actual Study Start Date December 1, 2018
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 14, 2018)
Ataxia Differences between DBS and no DBS [ Time Frame: Visit 2 (after DBS has been turned off for 3-10 days) ]
Compare the Scale of the Assessment and Rating of Ataxia (SARA) total score between DBS and no DBS participants with essential tremor. This 8-item scale rates gait (0-8 points), stance (0-6 points), sitting (0-4 points), speech disturbance (0-6 points), finger chase (0-4 points), nose-finger test (0-4 points), fast alternating hand movements (0-4 points), and heel-shin slide (0-4 points). Motor activists of the four extremities (items 5-8) assessments are performed bilaterally, mean values to obtain a total score. Cumulative score ranges from 0 (no ataxia) to 40 (most severe ataxia).
Original Primary Outcome Measures
 (submitted: December 6, 2018)
Ataxia Differences between DBS and no DBS [ Time Frame: Visit 2 (after DBS has been turned off for 3-10 days) ]
Compare the Scale of the Assessment and Rating of Ataxia (SARA) total score between DBS and no DBS participants with essential tremor
Change History Complete list of historical versions of study NCT03769961 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 14, 2018)
Balance Confidence [ Time Frame: Visit 2 (after DBS has been turned off for 3-10 days) ]
The Activities-Specific Balance Confidence Scale (ABC) is a subjective measure of confidence in performing various ambulatory activities without falling or experiencing a sense of unsteadiness. The ABC scale is a 16-item self-report measure in which participants rate their balance confidence on a 0-100 scale (0 = 0 no confidence, 100 = 100 complete confidence). Overall score is calculated by adding item scores and dividing by the total number of items.
Original Secondary Outcome Measures
 (submitted: December 6, 2018)
Balance Confidence [ Time Frame: Visit 2 (after DBS has been turned off for 3-10 days) ]
The Activities-Specific Balance Confidence Scale (ABC) is a subjective measure of confidence in performing various ambulatory activities without falling or experiencing a sense of unsteadiness.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Ataxia in Essential Tremor: Describing the Differences Between Disease Process and Treatment Effect
Official Title Ataxia in Essential Tremor: Describing the Differences Between Disease Process and Treatment Effect (ATAX)
Brief Summary The proposed study aims to characterize ataxia occurring in essential tremor and essential tremor with DBS.
Detailed Description

Objectives: In recent years, there has been a growing amount of evidence tying Essential Tremor (ET) to cerebellar dysfunction. This has been clinically observed, demonstrated through specific gait measures of ataxia (often involving tandem gait), and confirmed through Positron emission tomography (PET) imaging. Deep Brain stimulation for ET has become a widely utilized therapeutic intervention for patients, and the bilateral thalamic ventralis intermedius (VIM) is most commonly implanted. However, it has been noted that in some patients gait ataxia significantly worsens post-op. This initially was thought to be a result of disease progression, but recent studies have in fact shown that this is a DBS related phenomenon.

Methods: Participants will have two visits to either the Portland VA or Oregon Health & Science University (OHSU). At each visit, several assessments of balance, tremor, gait and balance, and DBS settings will be made. The gait and balance assessments will be performed by a unblinded and a blinded rater.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Essential Tremor participants with and without ataxia
Condition
  • Essential Tremor
  • Deep Brain Stimulation
  • Ataxia
  • Cerebellar Diseases
Intervention Other: No intervention
No interventions - Observational study
Study Groups/Cohorts
  • ET (DBS-, Ataxia+)
    Essential Tremor without DBS with Ataxia on examination
    Intervention: Other: No intervention
  • ET (DBS-, Ataxia-)
    Essential Tremor without DBS and without Ataxia on examination
    Intervention: Other: No intervention
  • ET (DBS+, Ataxia+)
    Essential Tremor with DBS with Ataxia on examination
    Intervention: Other: No intervention
  • ET (DBS+, Ataxia-)
    Essential Tremor with DBS without Ataxia
    Intervention: Other: No intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 6, 2018)
40
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2020
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Essential Tremor diagnosis at least 3 years duration
  • Absence of other neurological signes (such as dystonia, ataxia, or Parkinsonism)
  • Patients must be able to walk 2 minutes unassisted.
  • Patients must be able to understand and consent to be in the study.

Exclusion Criteria:

  • Patients who have had changes in DBS settings within the last 3 months.
  • Patients who have had no initial improvement or response to DBS.
  • ET medication changes in the last month.
  • Actively abusing alcohol.
  • A neurologic diagnosis other than ET that in the investigator's opinion could affect gait and/or balance.
  • Atypical tremor disorder including by not limited to tremor due to multiple sclerosis, medication-induced tremor, Parkinson's disease, or parkinsonian syndrome.
  • Dementia
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03769961
Other Study ID Numbers 18608
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Post data entry and verification, data and specimens will be de-identified (no 18 HIPAA identifiers and age aggregated for those > 89 years old) and transferred to the Neurological Disorder Repository (MIRB # 3129). This repository is maintained at the Portland VA Health Care System. Verification of the coded data set creation and the absence of the identifiers will be created and retained in the study files. The research coordinator will be responsible for the creation and verification process. The key to the code will be maintained by the study and will not be released to the repository. The recipient investigator must present the data use agreement, documentation of an Institutional Review Boar (IRB) approved protocol and Informed Conset Form (ICF) allowing the release of the identifiable specimens/data, or the release of coded specimens/data.
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Data will be available within 6 months of study completion.
Access Criteria: Data access requests will be reviewed by an external Independent Review Board. Requestors will be required to sign a data access agreement.
URL: https://www.portland.va.gov/research/
Responsible Party Amie Hiller, MD, Oregon Health and Science University
Study Sponsor Oregon Health and Science University
Collaborators Portland VA Medical Center
Investigators Not Provided
PRS Account Oregon Health and Science University
Verification Date December 2018