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Low enrollment
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| Name | Class |
|---|---|
| Portland VA Medical Center | FED |
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The proposed study aims to characterize ataxia occurring in essential tremor and essential tremor with DBS.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ET (DBS-, Ataxia+) | Essential Tremor without DBS with Ataxia on examination |
| |
| ET (DBS-, Ataxia-) | Essential Tremor without DBS and without Ataxia on examination |
| |
| ET (DBS+, Ataxia+) | Essential Tremor with DBS with Ataxia on examination |
| |
| ET (DBS+, Ataxia-) | Essential Tremor with DBS without Ataxia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No interventions - Observational study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ataxia Differences between DBS and no DBS | 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). | Visit 2 (after DBS has been turned off for 3-10 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Balance Confidence | 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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Inclusion Criteria:
Exclusion Criteria:
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Essential Tremor participants with and without ataxia
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97201 | United States | ||
| VA Portland Health Care System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27423573 | Background | 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. | |
| 24112892 | Result | 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. |
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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.
Data will be available within 6 months of study completion.
Data access requests will be reviewed by an external Independent Review Board. Requestors will be required to sign a data access agreement.
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| ID | Term |
|---|---|
| D020329 | Essential Tremor |
| D001259 | Ataxia |
| D002526 | Cerebellar Diseases |
| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020820 | Dyskinesias |
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| Visit 2 (after DBS has been turned off for 3-10 days) |
| Portland |
| Oregon |
| 97239 |
| United States |
| 19452239 | Result | 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. |
| 20926368 | Result | 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. |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001927 | Brain Diseases |