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

NCT05096572 | Terminated DMC FDA Device

• 1 other identifier: 21-500-225-80-04
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Essential Tremor

Outcome Measures

Primary Outcomes (4)

• Improvement in Tremor

  Tremor will be measured quantitatively using inertial measurement units. FTM-TRS will also be measured by the investigator.

  Following Two Weeks of Treatment At Each Intervention

• Change in Tremor Phenomenology

  Frequency and amplitude will be measured quantitatively using IMUs during postual, action, and intentional tasks.

  Following Two Weeks of Treatment At Each Intervention

• Change in Stimulation-Induced Balance

  Quantitative gait assessment utilizing the Zeno Walkway System will measure changes in balance at each visit.

  Following Two Weeks of Treatment At Each Intervention

• Change in Stimulation-Induced Dysarthria

  A dysarthria visual analog scale will measure dysarthria.

  Following Two Weeks of Treatment At Each Intervention

Study Arms (3)

Group 1

EXPERIMENTAL

Subjects will receive VIM stimulation for two weeks, followed by VIM+PSA stimulation for two weeks, and finally PSA stimulation for two weeks.

Device: VIM Stimulation; Device: PSA Stimulation; Device: VIM+PSA Stimulation

Group 2

EXPERIMENTAL

Subjects will receive VIM+PSA stimulation for two weeks, followed by PSA stimulation for two weeks, and finally VIM stimulation for two weeks.

Device: VIM Stimulation; Device: PSA Stimulation; Device: VIM+PSA Stimulation

Group 3

EXPERIMENTAL

Subjects will receive PSA stimulation for two weeks, followed by VIM stimulation for two weeks, and finally VIM+PSA stimulation for two weeks.

Device: VIM Stimulation; Device: PSA Stimulation; Device: VIM+PSA Stimulation

Interventions

VIM Stimulation DEVICE

Subjects will receive stimulation at VIM site only based on best settings ascertained during monopolar review.

Group 1; Group 2; Group 3

PSA Stimulation DEVICE

Subjects will receive stimulation at PSA site only based on best settings ascertained during monopolar review.

Group 1; Group 2; Group 3

VIM+PSA Stimulation DEVICE

Subjects will receive stimulation at VIM+PSA based on best settings ascertained during monopolar review.

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• St. Joseph's Hospital and Medical Center, Phoenix: lead

Study Sites (1)

Barrow Neurological Institite

Phoenix, Arizona, 85013, United States

Location

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Sana Aslam, DO

  St Josephs Hospital and Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: October 27, 2021
• Study Start: November 30, 2021
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)