MRgFUS treatment for tremor disorders

A Feasibility Study of MRgFUS in the Treatment of Therapy-Resistant Tremor-Related Patients With Low SDR Value

This study is testing a new ultrasound treatment for people with essential tremor or Parkinson's disease who haven't found relief from medication to see if it helps reduce their symptoms.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 22 Years to 99 Years
• Sex: All
• Sponsor: Chinese PLA General Hospital (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT05624385 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of Magnetic Resonance-guided Focused Ultrasound (MRgFUS) thalamotomy in patients with essential tremor and Parkinson's disease who have not responded to medication. Participants will undergo a series of imaging evaluations and clinical assessments to monitor treatment outcomes and any adverse effects. The study specifically targets individuals with a low skull density ratio, which is crucial for the success of the MRgFUS procedure. Follow-up evaluations will occur at multiple time points to assess the long-term effects of the treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 22 and older with medication-refractory essential tremor or Parkinson's disease and a skull density ratio of at least 0.28.

Not a fit: Patients with contraindications for MRI or those who cannot tolerate the MRgFUS procedure will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide significant relief from tremors for patients who have not benefited from traditional medications.

How similar studies have performed: Previous studies have shown that MRgFUS thalamotomy can be effective for treating tremor disorders, indicating a promising approach.

Eligibility criteria

Inclusion Criteria:

1. Men and women age 22 years or older;
2. Subjects are able and willing to agree to participate in the study and can accept all research visits;
3. A diagnosis of ET and PD as confirmed from clinical history and examination by a neurologist or neurosurgeon specialized in movement disorder and intolerance to side effects of medication or poor response to medication, severe and disabling tremor;
4. Able to adapt to MRI system;
5. To tolerate operation with or without some form of sedative (e.g., awake sedation);
6. Able to communicate with the doctor during the operation;
7. Able to use the "Stop ultrasonic processing" button;
8. Skull density ratio (SDR) ≥ 0.28.

Exclusion Criteria:

1. Subjects with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, known intolerance or allergies to the MRI contrast agent (e.g.Gadolinium or Magnevist) including advanced kidney disease, etc;
2. Pregnant woman;
3. Subjects with severely impaired renal function;
4. Subjects with unstable cardiac status or severe hypertension (diastolic BP \> 100 on medication);
5. Subjects show behaviors consistent with alcohol or drug abuse;
6. History of abnormal bleeding and/or coagulopathy/ or intracranial hemorrhage;
7. Patients who received anticoagulant therapy or medications known to increase the risk of bleeding within the month prior to receiving focused ultrasound treatment;
8. Cerebrovascular disease (multiple CVA or CVA within 3 months);
9. Subjects with brain tumors.
10. Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (can be up to 2 hrs of total time).

Where this trial is running

Beijing

• Chinese PLA General Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Yongqin Xiong, MD

Conditions Movement Disorders; Essential tremor; Parkinson disease; MRgFUS