Subthalamotomy by ExAblate Transcranial System to Treat Motor Features of Parkinson's Disease
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|ClinicalTrials.gov Identifier: NCT02912871|
Recruitment Status : Completed
First Posted : September 23, 2016
Last Update Posted : January 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Other: MRIgHIFU unilateral subthalamotomy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Clinical Trial of the Feasibility, Safety and Efficacy of Subthalamotomy Using the ExAblate Transcranial System to Treat the Cardinal Motor Features of Parkinson's Disease|
|Study Start Date :||April 2016|
|Actual Primary Completion Date :||January 2017|
|Actual Study Completion Date :||January 2017|
Experimental: MRIgHIFU unilateral subthalamotomy
Unilateral Subthalamotomy performed by MRI guided High intensity focused ultrasound in a single session.
Other: MRIgHIFU unilateral subthalamotomy
High Intensity focused ultrasound unilateral subthalamotomy: Unilateral thermolesion in the Subthalamic nucleus performed by High Intensity Focused ultrasound
- All causes of morbidity [ Time Frame: within the first 6 months (plus minus 1 month) after treatment ]Number of treatment-related adverse events as assessed by CTCAE v4.0
- Efficacy [ Time Frame: 6 months ]Improvement in the score of the Movement Disorders Unified Parkinson's Disease Rating Scale III (MDS-UPDRS III) that evaluates motor features of PD. The scale will be assessed pretreatment and after intervention and the reduction after treatment in the total MDS-UPDRS III score and the score in the treated hemibody will be measured. MDS-UPDRS III is a scale that assesses all the motor features of PD (akinesia, tremor, rigidity, gait disturbance). Score range between 0 (no presence of motor features) and 132 (maximum score for all items).
- MDS-UPDRS I [ Time Frame: 6 months ]MDS-UPDRS I evaluates non-motor symptoms of PD. Scores of the scales will be measured pretreatment and after procedure and compared.
- MDS-UPDRS II [ Time Frame: 6 months ]MDS-UPDRS II evaluates dependence in daily life activities. Scores of the scales will be measured pretreatment and after procedure and compared.
- MDS-UPDRS IV [ Time Frame: 6 months ]
MDS-UPDRS IV evaluates presence and impact of motor complications (i.e. motor fluctuations and dyskinesia).
Scores of the scales will be measured pretreatment and after procedure and compared.
- Dyskinesia severity as assessed through the Dyskinesia rating scale [ Time Frame: 6 months ]Dyskinesia rating scale assesses the presence of involuntary movements
- Levodopa equivalent medication usage (milligrams) when applicable [ Time Frame: 6 months ]
- Patient and Clinician Global Impression of Change [ Time Frame: 6 months ]
- Quality of life assessment with PDQ-39 [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02912871
|Principal Investigator:||Jose Obeso, MD, PhD||CINAC, HM Puerta del Sur. Avda. Carlos V nº 70. CP 28938. Móstoles MADRID (SPAIN) Tel: +34 91 2673201; Email: firstname.lastname@example.org|