RECRUITING

3-D Tractography FUS Ablation for Essential Tremor

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The investigators propose to advance Vim-FUSA (Ventral Intermediate Nucleus - Focused Ultrasound Ablation) with the support of 3-D tractography, a neuroimaging technique to visually represent nerve tracts within the brain. The investigators hypothesize that 3-D tractography Vim-FUSA will improve the Vim ablation compared to standard Vim-FUSA and prove safe and feasible in the clinical setting. The investigators also hypothesize that intraoperative magnetic resonance (i-MR) monitoring will differentiate ablated tissue from immediate perilesional edema and accurately predict the Vim-FUSA clinical outcomes.

Official Title

3-D Tractography Focused Ultrasound Ablation for Essential Tremor

Quick Facts

Study Start:2024-02-28

Study Completion:2028-02-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06331052

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Diagnosis of moderate to severe ET agreed upon by at least two movement disorder trained physicians * Symptoms refractory to at least two medications * Stable medication regimen for at least 4 weeks prior to screening * Willing and able to participate in all follow-up visits * Willing and able to undergo MR imaging.	* Uncontrolled hypertension * Medically unstable coronary artery disease * Coagulopathy, anticoagulant therapy, or inability to temporarily stop any antithrombotic medication * Tremor disorders other than ET * Unwilling or unable to undergo tremor surgery while awake * Significant and non-correctible motion artifact in imaging * Pregnant at the time of enrollment or preoperative evaluation * Dementia * History of psychosis * History of drug or alcohol abuse * Prior brain surgery such as Vim-FUSA, deep brain stimulation, and gamma knife thalamotomy * Botulinum toxin injection in the tremor-impacted areas three months prior to the baseline assessment and until 3-months after Vim-FUSA * Skull density ratio lower than 0.4 * Does not qualify for FDA-approved clinical use based on current FDA labeling * Any significant issue raised by the neurologist or neurosurgeon that may compromise participant safety or potentially interfere with study interpretation.

Inclusion Criteria

Exclusion Criteria

* Diagnosis of moderate to severe ET agreed upon by at least two movement disorder trained physicians
* Symptoms refractory to at least two medications
* Stable medication regimen for at least 4 weeks prior to screening
* Willing and able to participate in all follow-up visits
* Willing and able to undergo MR imaging.

* Uncontrolled hypertension
* Medically unstable coronary artery disease
* Coagulopathy, anticoagulant therapy, or inability to temporarily stop any antithrombotic medication
* Tremor disorders other than ET
* Unwilling or unable to undergo tremor surgery while awake
* Significant and non-correctible motion artifact in imaging
* Pregnant at the time of enrollment or preoperative evaluation
* Dementia
* History of psychosis
* History of drug or alcohol abuse
* Prior brain surgery such as Vim-FUSA, deep brain stimulation, and gamma knife thalamotomy
* Botulinum toxin injection in the tremor-impacted areas three months prior to the baseline assessment and until 3-months after Vim-FUSA
* Skull density ratio lower than 0.4
* Does not qualify for FDA-approved clinical use based on current FDA labeling
* Any significant issue raised by the neurologist or neurosurgeon that may compromise participant safety or potentially interfere with study interpretation.

Contacts and Locations

Study Contact

Heather L Ward, BS

CONTACT

+1 (919)-966-0720

heather_ward@med.unc.edu

Vibhor Krishna

CONTACT

+1(919)-445-2410

vibhor_krishna@med.unc.edu

Principal Investigator

Vibhor Krishna, MD

PRINCIPAL_INVESTIGATOR

University of North Carolina at Chapel Hll

Study Locations (Sites)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27999

United States

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

Vibhor Krishna, MD, PRINCIPAL_INVESTIGATOR, University of North Carolina at Chapel Hll

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-28

Study Completion Date2028-02-28

Study Record Updates

Study Start Date2024-02-28

Study Completion Date2028-02-28

Terms related to this study

Additional Relevant MeSH Terms

Essential Tremor