Recruiting

FUS Ablation

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT06331052

Conditions

Essential Tremor

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

MR-guided Focused Ultrasound Ablation

Study Details

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

Study ID

NCT06331052

Start date

Feb 28, 2024

Status verified date

Aug, 2026

Completion date

Feb 28, 2028

Anticipated

Primary completion date

Feb 28, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Inclusion 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 essential tremor 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.

Exclusion Criteria:

  • Uncontrolled hypertension
  • Medically unstable coronary artery disease
  • Coagulopathy with inability to temporarily stop any antithrombotic medication
  • Tremor disorders other than ET (e.g., Parkinson disease, traumatic tremor, alcohol or drug dependent tremor that remains after at least 2 weeks of abstinence etc.)
  • 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
  • Prior brain surgery that could influence the focused ultrasound procedure outcomes, including deep brain stimulation
  • Botulinum toxin injection in the tremor-impacted areas three months prior to the baseline assessment and until 3-months after Vim-FUSA
  • does not qualify for FDA-approved clinical use based on current FDA labeling except that skull density ratio ≤ 0.4 will be allowed for this study
  • Any significant issue raised by the neurologist or neurosurgeon that may compromise participant safety or potentially interfere with study interpretation.
  • non-English speaking

Study Design

Enrollment

24 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 3-D Tractography Vim FUSA

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

Interventions

MR-guided Focused Ultrasound Ablation

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).

Primary outcome measure

  • Number of Participants without Side Effects [ Time Frame: during the surgical procedure ]
  • Absolute Change in Tremor [ Time Frame: Baseline, Month 3 ]
  • Relative Change in Tremor [ Time Frame: Baseline, Month 3 ]

Central Contacts and Locations

Central contacts

Vibhor Krishna, MD

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

Victoria Scott

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

Locations

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Victoria Scott

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

Vibhor Krishna, MD, SM

919-445-2410vibhor_krishna@med.unc.edu

Principal Investigator:

Vibhor Krishna, MD, SM

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Sep 8, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2026-09-08.