- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03769961
Ataxia in Essential Tremor: Describing the Differences Between Disease Process and Treatment Effect (ATAX)
Ataxia in Essential Tremor: Describing the Differences Between Disease Process and Treatment Effect (ATAX)
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Oregon
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Portland, Oregon, United States, 97201
- Oregon Health & Science University
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Portland, Oregon, United States, 97239
- VA Portland Health Care System
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
ET (DBS-, Ataxia+)
Essential Tremor without DBS with Ataxia on examination
|
No interventions - Observational study
|
ET (DBS-, Ataxia-)
Essential Tremor without DBS and without Ataxia on examination
|
No interventions - Observational study
|
ET (DBS+, Ataxia+)
Essential Tremor with DBS with Ataxia on examination
|
No interventions - Observational study
|
ET (DBS+, Ataxia-)
Essential Tremor with DBS without Ataxia
|
No interventions - Observational study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
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Visit 2 (after DBS has been turned off for 3-10 days)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Balance Confidence
Time Frame: Visit 2 (after DBS has been turned off for 3-10 days)
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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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Visit 2 (after DBS has been turned off for 3-10 days)
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Collaborators and Investigators
Collaborators
Publications and helpful links
General Publications
- Ramirez-Zamora A, Boggs H, Pilitsis JG. Reduction in DBS frequency improves balance difficulties after thalamic DBS for essential tremor. J Neurol Sci. 2016 Aug 15;367:122-7. doi: 10.1016/j.jns.2016.06.001. Epub 2016 Jun 2.
- Nazzaro JM, Lyons KE, Pahwa R. Deep brain stimulation for essential tremor. Handb Clin Neurol. 2013;116:155-66. doi: 10.1016/B978-0-444-53497-2.00013-9.
- Kronenbuerger M, Konczak J, Ziegler W, Buderath P, Frank B, Coenen VA, Kiening K, Reinacher P, Noth J, Timmann D. Balance and motor speech impairment in essential tremor. Cerebellum. 2009 Sep;8(3):389-98. doi: 10.1007/s12311-009-0111-y. Epub 2009 May 19.
- Fasano A, Herzog J, Raethjen J, Rose FE, Muthuraman M, Volkmann J, Falk D, Elble R, Deuschl G. Gait ataxia in essential tremor is differentially modulated by thalamic stimulation. Brain. 2010 Dec;133(Pt 12):3635-48. doi: 10.1093/brain/awq267. Epub 2010 Oct 5.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18608
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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