DBS of Posterior Subthalamic Area (PSA) and Ventral Intermediate Nucleus (VIM) in Essential Tremor (ET)

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
St. Joseph's Hospital and Medical Center, Phoenix
Study ID
NCT05096572
Status
Terminated

Conditions

  • Essential Tremor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • VIM Stimulation — DEVICE
    Subjects will receive stimulation at VIM site only based on best settings ascertained during monopolar review.
  • PSA Stimulation — DEVICE
    Subjects will receive stimulation at PSA site only based on best settings ascertained during monopolar review.
  • VIM+PSA Stimulation — DEVICE
    Subjects will receive stimulation at VIM+PSA based on best settings ascertained during monopolar review.

Study Details

Deep brain stimulation (DBS) of the ventral intermediate nucleus of the thalamus (VIM) is an FDA approved treatment for medication refractory essential tremor (ET). However, VIM stimulation can be associated with impacts on speech and balance. There is also suggestion that there may be habituation to stimulation in more than half of these patients. Stimulation of the posterior subthalamic area (PSA) has been found to be beneficial in tremor control as well. In fact, there is thought that the improvement in tremor in standard VIM DBS stimulation may be related to stimulation effects on the PSA. Updates in DBS stimulation allow to stimulate more than one area of the brain independently, while using a single lead. In this study, we will recruit patient who are referred for VIM DBS to a randomized cross-over trial in which they will receive VIM, PSA, or dual stimulation. We will assess tremor qualitatively and quantitatively, in addition to evaluating side effects, including quantitative gait analysis on each setting. The pre-operative, operative, and initial programming evaluation will be performed per standard of care. After baseline assessment and initial programming, subjects will be evaluated in a blinded manner after they have been on each setting for 2 weeks. The entire duration of the study from baseline visit through final study visit will be 17 weeks. For subjects who are clinically evaluated in our outpatient clinics, we will review their charts at 6 months for stimulation parameters and clinical information as it relates to their tremor.

Key Dates

First listed
Oct 27, 2021
Start date
Nov 30, 2021
Status verified
Nov 2023
Primary completion
Oct 30, 2023
Completion
Oct 30, 2023

Study Design

Enrollment
1 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1
    Subjects will receive VIM stimulation for two weeks, followed by VIM+PSA stimulation for two weeks, and finally PSA stimulation for two weeks.
  • Experimental: Group 2
    Subjects will receive VIM+PSA stimulation for two weeks, followed by PSA stimulation for two weeks, and finally VIM stimulation for two weeks.
  • Experimental: Group 3
    Subjects will receive PSA stimulation for two weeks, followed by VIM stimulation for two weeks, and finally VIM+PSA stimulation for two weeks.

Primary Outcome Measure

Improvement in Tremor [ Time Frame: Following Two Weeks of Treatment At Each Intervention ]

Locations (1)

FacilityCityStateZIPSite coordinators
Barrow Neurological InstititePhoenixArizona85013-

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By research site
Barrow Neurological Institite· Phoenix, AZ

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