NCT07168850View on ClinicalTrials.gov

Focused Ultrasound Unilateral Pallidotomy for Medication-Refractory Limb Dystonia

NARecruitingINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

January 27, 2025

Primary Completion Date

February 28, 2027

Study Completion Date

February 28, 2027

Conditions
Limb DystoniaIdiopathic DystoniaMedication-refractory DystoniaDystonia, Focal
Interventions
DEVICE

Exablate MR-guided Focused Ultrasound Pallidotomy

Active Pallidotomy

DEVICE

Sham Sham Exablate MRgFUS Pallidotomy

Sham procedure. Identical setup without thermal lesioning. Participants cross over to Active Pallidotomy after 3 months.

Trial Locations (4)

20133

RECRUITING

Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan

30174

RECRUITING

Azienda ULSS3 Serenissima, Mestre

90146

RECRUITING

Azienda Ospedaliera Ospedali Riuniti Villa Sofia, Palermo

98124

RECRUITING

"IRCCS Centro Neurolesi Bonino-Pulejo", Messina

All Listed Sponsors
collaborator

Azienda ULSS 3 Serenissima

OTHER

collaborator

IRCCS Centro Neurolesi Bonino Pulejo

OTHER

collaborator

Azienda Ospedaliera Villa Sofia

UNKNOWN

lead

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

OTHER