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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

Brief Summary:
The proposed study aims to characterize ataxia occurring in essential tremor and essential tremor with DBS.

Condition or disease Intervention/treatment
Essential Tremor Deep Brain Stimulation Ataxia Cerebellar Diseases Other: No intervention

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.


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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Ataxia in Essential Tremor: Describing the Differences Between Disease Process and Treatment Effect (ATAX)
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : December 31, 2020


Group/Cohort Intervention/treatment
ET (DBS-, Ataxia+)
Essential Tremor without DBS with Ataxia on examination
Other: No intervention
No interventions - Observational study

ET (DBS-, Ataxia-)
Essential Tremor without DBS and without Ataxia on examination
Other: No intervention
No interventions - Observational study

ET (DBS+, Ataxia+)
Essential Tremor with DBS with Ataxia on examination
Other: No intervention
No interventions - Observational study

ET (DBS+, Ataxia-)
Essential Tremor with DBS without Ataxia
Other: No intervention
No interventions - Observational study




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Essential Tremor participants with and without ataxia
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769961


Locations
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United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97201
Contact: Brenna M Lobb, MS    503-220-8262 ext 51871    lobbb@ohsu.edu   
Contact: PADRECC    503-721-1091      
Principal Investigator: Amie A Hiller, MD         
VA Portland Health Care System Recruiting
Portland, Oregon, United States, 97239
Contact: Brenna M Lobb, MS MPH    503-220-8262 ext 51871    lobbb@ohsu.edu   
Contact: Susan OConnor, RN    5032208262 ext 55336      
Principal Investigator: Jennifer Nichols, MD         
Sponsors and Collaborators
Oregon Health and Science University
Portland VA Medical Center

Publications of Results:
Other Publications:
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Responsible Party: Amie Hiller, MD, Associate Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT03769961     History of Changes
Other Study ID Numbers: 18608
First Posted: December 10, 2018    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: December 2018
Individual Participant Data (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
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/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amie Hiller, MD, Oregon Health and Science University:
essential tremor
dbs
Additional relevant MeSH terms:
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Ataxia
Cerebellar Ataxia
Tremor
Essential Tremor
Cerebellar Diseases
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases
Movement Disorders