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Application of multimodal magnetic resonance-guided bilateral staged focused ultrasound in movement disorders

Application of multimodal magnetic resonance-guided bilateral staged focused ultrasound in movement disorders

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081205
Enrollment
Unknown
Registered
2024-02-26
Start date
2024-03-01
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

Essential Tremor, Parkinson's Disease, Segmental Dystonia

Interventions

Essential Tremor:Staged bilateral Ventral intermediate nucleus Magnetic Resonance-Guided Focused Ultrasound
Parkinson’s Disease:Staged bilateral pallidothalamic tract Magnetic Resonance-Guided Focused Ultrasound
Segmental Dystonia:Staged bilateral pallidothalamic tract Magnetic Resonance-Guided Focused Ultrasound

Sponsors

Xuanwu Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 100 Years

Inclusion criteria

Inclusion criteria: a. Diagnosed with essential tremor (refer to the 2018 MDS Tremor Consensus), essential Parkinson's disease (refer to the 2015 MDS UPDRS Diagnostic Criteria), segmental dystonia (refer to the 2020 Chinese Expert Consensus of the Chinese Medical Association), the course of the disease is = 5 years, drug refractory; b. Complete the assessment and follow-up at the outpatient clinics of the two centers; c. Meet the definition of drug refractory; d. Able to cooperate with multi-modal magnetic resonance and head CT scanning; e. Unable or refusing craniotomy due to physical or psychological factors; f. Able to complete follow-up assessment within 1 year of first side treatment and receive second side treatment.

Exclusion criteria

Exclusion criteria: a. Those who have dysarthria, swallowing disorder, balance gait disorder, and cognitive impairment before the first treatment; b. Those who have metal implants or cannot cooperate with the completion of magnetic resonance scanning due to physiological and psychological reasons; c. Skull density ratio (SDR) less than 0.40, calculated based on screening head CT; d. Those with coagulation dysfunction or surgical contraindications such as anticoagulant or antiplatelet therapy within 1 week before treatment; e. Participation in other clinical trials within the past three months and during the study enrollment period; f. Suffering from other serious chronic diseases that may confound the efficacy of the treatment or the interpretation of the data; g. Moderate to severe neurological impairment, such as dysarthria, swallowing disorder, gait balance disorder, cognitive dysfunction, etc., during the 1-year follow-up period after the first side treatment; h. Women who are pregnant or breast feeding.

Design outcomes

Secondary

MeasureTime frame
Quality of Life of Essential Tremor, QUEST;Parkinson's Disease Questionnaire - 39, PDQ-39;Toronto Western Spasmodic Torticollis Rating Scale, TWSTRS;

Primary

MeasureTime frame
Clinical Rating Scale for Tremor, CRST;Unified-Parkinson Disease Rating Scale, UPDRS;Craniocervical dystonia questionnaire, CDQ-24;

Countries

China

Contacts

Public ContactJianyu Li

Xuanwu Hospital, Capital Medical University

lijianyu@vip.sohu.com+86 10 8319 9238

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026