Comparing Conventional Targeting Versus Tractographic Planning with DRTx Tracking in Unilateral High-Intensity Focused Ultrasound (HiFUS) Thalamotomy for Essential Tremor: A Randomized Controlled Trial with retrospective Analysis of AI-supported Rubral Wing Visualization

Comparing Conventional Targeting Versus Tractographic Planning with DRTx Tracking in Unilateral High-Intensity Focused Ultrasound (HiFUS) Thalamotomy for Essential Tremor: A Randomized Controlled Trial with retrospective Analysis of AI-supported Rubral Wing Visualization - TARGET

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00037838

Enrollment

Registered

2026-05-18

Start date

2026-10-01

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G25.0

Interventions

Group 1: Tractographic HiFUS treatment Planning with DRTx Tracking Group 2: Traditional landmark-based HiFUS treatment Targeting

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Patients with essential tremor refractory to at least two tremor medications - either by efficacy or side effects. 2. Suitable for unilateral HiFUS based on standard MR safety guidelines. 3. Eligibility for HiFUS according to guideline-based decision of interdisciplinary Movement Disorder Conference 4. Age 18-85 years 5. Adequate skull bone density (SDR =0.4) 6. Informed consent for study participation after education by study physician

Exclusion criteria

Exclusion criteria: 1. Contraindications for HiFUS treatment 2. Contraindications for MRI without sedation (metal implants, pacemaker, claustrophobia) 3. Prior thalamic intervention (surgical or ablative). 4. Secondary or atypical tremor 5. Other neurological diseases with tremor (Parkinson's syndrome, dystonia) 6. Cognitive impairment (MoCA < 24) 7. Progressive neurodegenerative diseases 8. Severe psychiatric diseases 9. Coagulation disorders or non-pausable anticoagulant therapy 10. Pregnancy or breastfeeding

Design outcomes

Primary

Measure	Time frame
To compare efficacy and side effects of tractographic planning with DRTx tracking versus traditional landmark-based targeting in unilateral HiFUS thalamotomy for tremor reduction in patients with essential tremor.	—

Secondary

Measure	Time frame
- To compare treatment time and number of sonications between groups - To assess patient-reported quality of life improvements - Identification of predictive factors for response to treatment and occurrence of side effects - To characterize lesion topography and size as well as longitudinal microstructural changes - To retrospectively analyze AI-segmented rubral wing (and other anatomical landmarks) characteristics and their correlation with targeting precision and clinical outcomes - To evaluate the potential of AI-segmented rubral wing for future targeting improvements considering inter-rater variability in manual segmentation	—

Measure

Time frame

- To compare treatment time and number of sonications between groups - To assess patient-reported quality of life improvements - Identification of predictive factors for response to treatment and occurrence of side effects - To characterize lesion topography and size as well as longitudinal microstructural changes - To retrospectively analyze AI-segmented rubral wing (and other anatomical landmarks) characteristics and their correlation with targeting precision and clinical outcomes - To evaluate the potential of AI-segmented rubral wing for future targeting improvements considering inter-rater variability in manual segmentation

—

Countries

Germany

Contacts

Public ContactBastian Sajonz

Universitätsklinikum Freiburg - Abteilung für Stereotaktische und Funktionelle Neurochirurgie

bastian.sajonz@uniklinik-freiburg.de+49 761 270-93030

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026