3-D Tractography FUS Ablation for Essential Tremor
A legfontosabb adatok
- Hol
- Chapel Hill (Egyesült Államok)A helyszín megnézése
Helyszínek itt: Egyesült Államok
- University of North Carolina at Chapel HillChapel Hill, Egyesült ÁllamokContact: Victoria ScottRésztvevőt keres
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- University of North Carolina, Chapel Hill
- Azonosító
- NCT06331052
- A regiszteradat frissítve
- 2026. szeptember 8.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
3-D Tractography Focused Ultrasound Ablation for Essential Tremor
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.
Bevonási feltételek: 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.
Kizáró feltételek: Coagulopathy with inability to temporarily stop any antithrombotic medication; Unwilling or unable to undergo tremor surgery while awake; 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; Uncontrolled hypertension; Medically unstable coronary artery disease; 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.); Dementia; History of psychosis; Significant and non-correctible motion artifact in imaging; Pregnant at the time of enrollment or preoperative evaluation; 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.