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

Oregon Health & Science University (OHSU) logo

Oregon Health & Science University (OHSU)

Status

Terminated

Conditions

Ataxia
Essential Tremor
Cerebellar Diseases
Deep Brain Stimulation

Treatments

Other: No intervention

Study type

Observational

Funder types

Other
Other U.S. Federal agency

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

6 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

6 participants in 4 patient groups

ET (DBS-, Ataxia+)
Description:
Essential Tremor without DBS with Ataxia on examination
Treatment:
Other: No intervention
ET (DBS-, Ataxia-)
Description:
Essential Tremor without DBS and without Ataxia on examination
Treatment:
Other: No intervention
ET (DBS+, Ataxia+)
Description:
Essential Tremor with DBS with Ataxia on examination
Treatment:
Other: No intervention
ET (DBS+, Ataxia-)
Description:
Essential Tremor with DBS without Ataxia
Treatment:
Other: No intervention

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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