A Feasibility Study on the Safety and Preliminary Efficacy of Bilateral Subthalamotomy Using MRgFUS for Treatment of PD

Parkinson Disease Clinical Trial

Official title:

A Feasibility Study on the Safety and Preliminary Efficacy of Bilateral Subthalamotomy Using the ExAblate Transcranial System to Treat the Cardinal Motor Features of Parkinson's Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03964272
• Other study ID #: PD010B
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 18, 2019
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2022
• Source: InSightec
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to test the safety and preliminary efficacy of staged bilateral subthalamotomy performed using the ExAblate Transcranial System for the treatment of Parkinson's disease (PD) motor features

Description:

The objective of this study is to evaluate the incidence and severity of adverse events (AE/AEs) associated with ExAblate Transcranial Magnetic Resonance Guided Focused Ultrasound (MRgFUS) bilateral staged subthalamotomy for the treatment of PD motor features. To determine the effectiveness of the ExAblate Transcranial staged bilateral subthalamotomy to treat cardinal motor features of subjects with PD.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3
• Est. completion date: June 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Male or Female age 30 years or older

2. Able and willing to give consent and able to attend all study visits

3. A confirmed diagnosis of Parkinsons Disease

4. Subjects that have received unilateral subthalamotomy at least 6 month before the inclusion in bilateral subthalamotomy and present parkinsonian symptoms

5. Able to localize subthalamic nucleus on MRI for treatment

6. Able to communicate sensations during the ExAblate MRgFUS procedure

Exclusion Criteria:

1. Hoehn and Yahr stage in the ON medication state of 2.5 or greater

2. Presence of severe dyskinesia as noted by MDS-UPDRS scores

3. Presence of other central neurodegenerative disease

4. Parkinsonian symptoms are a side effect from neuroleptic medications

5. Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse

6. History of a bleeding disorder or receiving anticoagulant

7. Subjects with advanced kidney disease or on dialysis

8. Subjects with known intolerance or allergies to the MRI contrast agents.

9. Presence of unknown or MRI unsafe devices anywhere in the body.

10. History of multiple strokes, or a stroke within past 6 months

11. Subjects with a history of seizures within the past year

12. Subjects with malignant brain tumors

13. Women who are pregnant or nursing

Related Conditions & MeSH terms

• Neurologic Manifestations
• Parkinson Disease

Intervention

Device:
• Exablate Bilateral Subthalamotomy
Exablate bilateral treatment for Parkinson's Disease Motor Features

Locations

Country	Name	City	State
Spain	Hospital Universitario HM Puerta Del Sur. CINAC	Móstoles	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
InSightec

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Adverse Events	To evaluate the incidence and severity of adverse events (AE/AEs) associated with ExAblate subthalamotomy for the treatment of PD motor features.	Treatment through 6 month
Primary	Primary Efficacy: Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Off Medication Status	Effectiveness of the ExAblate Transcranial staged bilateral subthalamotomy by analyzing mean change (reduction from baseline to 6 months) in the motor MDS-UPDRS score in the treated group as compared with baseline in the off-medication condition	Treatment through 6 month
Secondary	Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) On Medication Status	- Mean change (reduction) in the motor MDS-UPDRS score in the on-medication condition (when applicable)	Treatment through 6 month
Secondary	MDS-UPDRS	- Mean change (reduction) in specific PD motor features (i.e., tremor, rigidity and akinesia according to MDS-UPDRS III subscores)	Treatment through 12 month
Secondary	MDS-UPDRS (Part I, II and IV)	MDS UPDRS I, II and IV	Treatment through 6 month
Secondary	Quality of life assessment	Improved Quality of life assessment with the PDQ39	Treatment through 6 month