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

NCT ID: NCT03769961

Last Updated: 2020-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-01

Study Completion Date

2020-09-14

Brief Summary

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

Detailed Description

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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.

Conditions

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Essential Tremor Deep Brain Stimulation Ataxia Cerebellar Diseases

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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ET (DBS-, Ataxia+)

Essential Tremor without DBS with Ataxia on examination

No intervention

Intervention Type OTHER

No interventions - Observational study

ET (DBS-, Ataxia-)

Essential Tremor without DBS and without Ataxia on examination

No intervention

Intervention Type OTHER

No interventions - Observational study

ET (DBS+, Ataxia+)

Essential Tremor with DBS with Ataxia on examination

No intervention

Intervention Type OTHER

No interventions - Observational study

ET (DBS+, Ataxia-)

Essential Tremor with DBS without Ataxia

No intervention

Intervention Type OTHER

No interventions - Observational study

Interventions

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No intervention

No interventions - Observational study

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Portland VA Medical Center

FED

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Amie Hiller, MD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Oregon Health & Science University

Portland, Oregon, United States

Site Status

VA Portland Health Care System

Portland, Oregon, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 27423573 (View on PubMed)

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.

Reference Type RESULT
PMID: 24112892 (View on PubMed)

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.

Reference Type RESULT
PMID: 19452239 (View on PubMed)

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.

Reference Type RESULT
PMID: 20926368 (View on PubMed)

Other Identifiers

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18608

Identifier Type: -

Identifier Source: org_study_id

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