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

NCT03769961 | Terminated

• 1 other identifier: 18608
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Essential Tremor; Deep Brain Stimulation; Ataxia; Cerebellar Diseases

Keywords

essential tremor; dbs

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• Balance Confidence

  Visit 2 (after DBS has been turned off for 3-10 days)

Study Arms (4)

ET (DBS-, Ataxia+)

Essential Tremor without DBS with Ataxia on examination

Other: No intervention

ET (DBS-, Ataxia-)

Essential Tremor without DBS and without Ataxia on examination

Other: No intervention

ET (DBS+, Ataxia+)

Essential Tremor with DBS with Ataxia on examination

Other: No intervention

ET (DBS+, Ataxia-)

Essential Tremor with DBS without Ataxia

Other: No intervention

Interventions

No intervention OTHER

No interventions - Observational study

ET (DBS+, Ataxia+); ET (DBS+, Ataxia-); ET (DBS-, Ataxia+); ET (DBS-, Ataxia-)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Essential Tremor participants with and without ataxia

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Portland VA Medical Center: collaborator

Study Sites (2)

Oregon Health & Science University

Portland, Oregon, 97201, United States

Location

VA Portland Health Care System

Portland, Oregon, 97239, United States

Location

Related Publications (4)

• 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.

  PMID: 27423573 BACKGROUND

• 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.

  PMID: 24112892 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.

  PMID: 19452239 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.

  PMID: 20926368 RESULT

MeSH Terms

Conditions

Essential Tremor; Ataxia; Cerebellar Diseases

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: December 10, 2018
• Study Start: December 1, 2018
• Primary Completion: September 14, 2020
• Study Completion: September 14, 2020
• Last Updated: September 17, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

US (2)