Clinical Trials Directory

Trials / Terminated

TerminatedNCT03769961

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

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

Status
Terminated
Phase
Study type
Observational
Enrollment
6 (actual)
Sponsor
Oregon Health and Science University · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

Summary

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

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.

Conditions

Interventions

TypeNameDescription
OTHERNo interventionNo interventions - Observational study

Timeline

Start date
2018-12-01
Primary completion
2020-09-14
Completion
2020-09-14
First posted
2018-12-10
Last updated
2020-09-17

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT03769961. Inclusion in this directory is not an endorsement.