3-D Tractography FUS Ablation for Essential Tremor

ConditionEssential Tremor

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age22+

SponsorUniversity of North Carolina, Chapel Hill

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.)

Trial design

Design model

Single group

Treatments tested in this trial

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).

Treatment groups

24 Participants

are divided into 1 treatment group

Group A: 3-D Tractography Vim FUSAExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Number of Participants without Side Effects

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

Time frame

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).

Time frame

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).

Time frame

Baseline, Month 3

Secondary outcomes

Number of Participants with Procedure-Related Side Effects

Prevalence and severity of procedure-related side effects measured by the following: ataxia (SARA), speech disturbance (VHI), sensory loss (SWME), muscle weakness (MRC)

Time frame

3 months after the surgical procedure

Relative Change in Tremor-Related Quality of Life

The Quality of Life Essential Tremor Questionnaire (QUEST) will be used to assess tremor-related quality of life. QUEST has scores ranging from 0 to 100 with higher scores indicating worse disability.

Time frame

3 months after the surgical procedure

Number of Participants Who Are Satisfied with Treatment

Measured using a single question asking about patient satisfaction ranging from 1 to 5 with higher scores indicating higher satisfaction.

Time frame

3 months after the surgical procedure

Other outcomes

Change in Tremor Based on Video Assessment

Upper extremity tremors will be measured by video recording using i-Phone set-up.

Time frame

Baseline, during the surgical procedure

Change in Gait Based on Video Assessment

Gait will be measured by video recording using i-Phone set-up.

Time frame

Baseline, during the surgical procedure

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of North Carolina, Chapel Hill

Lead sponsor

University of Pittsburgh

Collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

University of Missouri-Columbia

Collaborator

Source ClinicalTrials.gov

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