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

Stopped early · Not applicable

Conditions studied: Essential Tremor

In brief

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 facts

Study ID

NCT05096572

Run by

St. Joseph's Hospital and Medical Center, Phoenix

People needed

1

Starts

2021-11-30

Expected to finish

2023-10-30

Last updated by the study team

2023-11-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients with a diagnosis of ET, refractory to pharmacotherapy referred for DBS consideration.
• Informed consent signed by the subject.
• DBS candidate per FDA guidelines.
• Primary language - English
• Physically and cognitively capable of completing evaluations and consent
• Medically cleared for surgery and anesthesia
• Negative pregnancy test prior to surgery for female subjects of child-bearing potential.

You may not qualify if…

• Any individuals with contraindication to bilateral DBS lead placement, history of dementia per DSM-V criteria, intracranial hemorrhage, or psychiatric illness.
• Conditions precluding MRI.
• History of supraspinal disease.
• Subjects with a history of seizure disorder.
• Subjects who have made a suicide attempt within the prior year,
• Subjects with any medical contraindications to undergoing DBS surgery (eg, infection, coagulopathy, or significant cardiac or other medical risk factors for surgery)
• Subjects with an implanted stimulator such as a cardiac pacemaker, defibrillator, neurostimulator and cochlear implant
• Subjects who are pregnant or nursing.
• Patient that is unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the protocol.
• Any other reasons that, in the opinion of the investigator, the candidate is determined to be unsuitable for entry into the study.

Where it is running

• Barrow Neurological Institite — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.