Parkinson Disease
Conditions
Keywords
Parkinson's Disease, ExAblate, MRgFUS, Sub-Thalamotomy
Brief summary
The objective of this study is to test the efficacy and safety of unilateral subthalamotomy performed using the ExAblate System for the treatment of Parkinson's disease (PD) motor features.
Detailed description
A Prospective, Randomized, Sham Controlled Study to Evaluate the Safety and Efficacy of ExAblate Subthalomotomy for the treatment of Parkinson's disease motor features. The objective of this prospective, randomized, double-blind (to subjects, examining neurologists and external video-based examination by Movement Disorders neurologist), two-arm study (ExAblate treated arm Vs ExAblate Sham treated control arm) is to confirm the efficacy of ExAblate Model 4000 Type 1 System for the treatment of Parkinson's disease (PD) motor features and to further demonstrate safety.
Interventions
DEVICEExablate Subthalamotomy
ExAblate Subthalomotomy for the Treatment of Parkinson's Disease Motor Features
DEVICESham Exablate Subthalamotomy
Sham ExAblate Subthalomotomy for the Treatment of Parkinson's Disease Motor Features
Sponsors
InSightec
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Men and women age 30 years or older 2. Subjects who are able and willing to give consent and able to attend all study visits. 3. Subjects with a diagnosis of PD by UK Brain Bank Criteria as confirmed by a movement disorder neurologist at the site. 4. Predominant motor features/disability from one side of the body (i.e asymmetry index \> 1.5) as determined by a movement disorders neurologist. 5. Motor clinical features non-optimally controlled by an adequate medical treatment prescription. An adequate medication prescription is defined as a therapeutic dose of each medication or the development of side effects as the medication dose is titrated. 6. No major changes in pharmacological regime for PD should be done for the 30 days prior to procedure. 7. Topographic coordinates of the subthalamic nucleus are localizable on MRI so that it can be targeted by the ExAblate device. 8. Able to communicate sensations during the ExAblate MRgFUS treatment Inclusion and
Exclusion criteria
have been agreed upon by two members of the medical team
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy - MDS-UPDRS | Baseline to 4 months post treatment | between-group differences in the mean change (from baseline to 4 months) in the motor MDS-UPDRS score for the side contralateral to subthalamotomy (in the treated group) as compared with mean change in the MDS-UPDRS score for the side contralateral to the alleged subthalamotomy (in the sham-procedure group) in the off-medication condition |
| Safety - Adverse Events | Baseline to 4 Months post treatment | To evaluate the incidence and severity of adverse events (AE/AEs) associated with ExAblate subthalamotomy for the treatment of PD motor features. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MDS-UPDRS III ON-medication | Baseline to Month 4 post treatment | MDS-UPDRS III score in the contralateral body side ON-medication condition as measured by the BLINDED assessor |
| MDS-UPDRS III OFF-medication | Baseline to Month 4 post treatment | MDS-UPDRS III score in the contralateral body side OFF-medication condition as measured by the UNBLINDED assessor |
| MDS-UPDRS III- Contralateral ON-medication | Baseline to Month 4 post treatment | MDS-UPDRS III score in the contralateral body side ON-medication condition as measured by the UNBLINDED assessor |
| MDS-UPDRS III | Baseline to Month 4 post treatment | Specific PD motor features sub-scores (rigidity, bradykinesia, tremor) of MDS- UPDRS III in the contralateral body side by visit for the following: OFF and ON-medication condition as measured by the BLINDED assessor |
| MDS-UPDRS II | Baseline to Month 4 post treatment | Total score of MDS-UPDRS II |
| MDS-UPDRS III Blinded assessor | Baseline to Month 4 post treatment | Total score of MDS-UPDRS III as measured by the BLINDED assessor OFF- and ON-medication |
| MDS-UPDRS IV | Baseline to Month 4 post treatment | Total score of MDS-UPDRS IV and separated by each type of motor complication |
| PDG39 | Baseline to Month 12 post treatment | Quality of life assessment with the PDQ39. |
| GIC | Baseline to Month 4 post treatment | Patient global impression of change from Baseline to Month 4 FU. |
| Levodopa | Baseline to Month 12 post treatment | Levodopa equivalent medication change usage (mg). |
| MDS-UPDRS | Baseline to Month 12 post treatment | Durability of the reduction in the contralateral motor MDS-UPDRS at 12 months in the treated group (measured only by the UNBLINDED assessor) |
Countries
Spain
Outcome results
None listed