Ataxia in Essential Tremor: Describing the Differences Between Disease Process and Treatment Effect
NCT ID: NCT03769961
Last Updated: 2020-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
6 participants
OBSERVATIONAL
2018-12-01
2020-09-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Cerebello-thalamo-cortical Coupling in Essential Tremor
NCT02346409
Using Real-time fMRI Neurofeedback and Motor Imagery to Enhance Motor Timing and Precision in Cerebellar Ataxia
NCT05436262
Next-Generation Pre-Operative Targeting for Thalamic DBS in the Treatment of Tremor
NCT03875404
Neurophysiologic Study of Patient With Essential Tremor and Dystonic Tremor
NCT03041714
Efficacy of tDCS in Degenerative Ataxia
NCT07250321
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ET (DBS-, Ataxia+)
Essential Tremor without DBS with Ataxia on examination
No intervention
No interventions - Observational study
ET (DBS-, Ataxia-)
Essential Tremor without DBS and without Ataxia on examination
No intervention
No interventions - Observational study
ET (DBS+, Ataxia+)
Essential Tremor with DBS with Ataxia on examination
No intervention
No interventions - Observational study
ET (DBS+, Ataxia-)
Essential Tremor with DBS without Ataxia
No intervention
No interventions - Observational study
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
No intervention
No interventions - Observational study
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Portland VA Medical Center
FED
Oregon Health and Science University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Amie Hiller, MD
Associate Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Oregon Health & Science University
Portland, Oregon, United States
VA Portland Health Care System
Portland, Oregon, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
18608
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.