3-D Tractography FUS Ablation for Essential Tremor

NCT06331052 | Recruiting DMC FDA Device

• 2 other identifiers: 23-24311R01NS125386-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Essential Tremor

Outcome Measures

Primary Outcomes (3)

• Number of Participants without Side Effects

  Feasibility is defined as the ability to complete the procedure without side effects.

  during the surgical procedure

• Absolute Change in Tremor

  The absolute change from baseline to Month 3 follow-up in upper extremity Tremor-Motor scores for the treated side is a sub-scale of Clinical Rating Scale for Tremor (CRST) Part A and Part B sum used to measure treated-side upper extremity tremor changes over time. Tremor-motor scores range from 0-32 points. Individual subject's scores at Baseline and 3 Months used to calculate absolute change from baseline and averaged across subjects. High absolute change from baseline is better (shows improvement).

  Baseline, Month 3

• Relative Change in Tremor

  The relative change from baseline to Month 3 follow-up in upper extremity Tremor-Motor scores for the treated side is a sub-scale of Clinical Rating Scale for Tremor (CRST) Part A and Part B sum used to measure treated-side upper extremity tremor changes over time. Tremor-motor scores range from 0-32 points. Individual subject's scores at Baseline and 3 Months used to calculate relative change from baseline and averaged across subjects. High relative change from baseline is better (shows improvement).

  Baseline, Month 3

Secondary Outcomes (3)

• Number of Participants with Procedure-Related Side Effects

  3 months after the surgical procedure

• Relative Change in Tremor-Related Quality of Life

  3 months after the surgical procedure

• Number of Participants Who Are Satisfied with Treatment

  3 months after the surgical procedure

Other Outcomes (2)

• Change in Tremor Based on Video Assessment

  Baseline, during the surgical procedure

• Change in Gait Based on Video Assessment

  Baseline, during the surgical procedure

Study Arms (1)

3-D Tractography Vim FUSA

EXPERIMENTAL

Twenty-four consecutive essential tremor (ET) participants undergoing Vim FUSA using 3-D tractography will be assessed at baseline and Month 3.

Device: MR-guided Focused Ultrasound Ablation

Interventions

MR-guided Focused Ultrasound Ablation DEVICE

3-D tractography Vim-FUSA -D tractography Vim-FUSA will be carried out as follows: (a) head shaving and placement of the stereotactic frame (Integra radionics frame, Integra Lifesciences, NJ, USA) secured to the skull with transcutaneous screws; (b) positioning on the procedure table and placement of the ultrasound transducer; (c) acquisition of conventional magnetic resonance (MR) imaging and co-registration with the CT head and 3-D tractography imaging acquired pre-surgically; (d) exploration of the target area with subtherapeutic sonications; (e) intraoperative monitoring with clinical testing of tremor and side effects with a standardized protocol. (f) Therapeutic sonications in the target area to deliver definitive ablation followed by clinical testing of tremor and side effects with a standardized protocol as described in section (e).

Also known as: 3-D Tractography

3-D Tractography Vim FUSA

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Texas Tech University Health Sciences Center, El Paso: collaborator
• University of Pittsburgh: collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Vibhor Krishna, MD

  University of North Carolina at Chapel Hll

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vibhor Krishna, MD

CONTACT

+1(919)-445-2410; vibhor_krishna@med.unc.edu

Victoria Scott

CONTACT

919-966-0864; Victoria_Scott@med.unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: March 26, 2024
• Study Start: February 28, 2024
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): February 28, 2028
• Last Updated: January 20, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 and continuing for 36 months following publication
• Access Criteria: Investigator has approved IRB, IEC REB and an executed data use/sharing agreement with UNC.

Locations

US (1)