Levodopa Induced Dyskinesia in Patients With Parkinson's Disease
Conditions
Keywords
Parkinson's disease, ultrasound, dyskinesia, magnetic resonance
Brief summary
The proposed study is to evaluate the safety and initial effectiveness of the ExAblate Transcranial MRI-guided focused ultrasound (MRgFUS) treatment of patients with dyskinesia of Parkinson's Disease (PD) * Safety: To evaluate the incidence and severity of adverse events (AE/AEs) associated with ExAblate Transcranial MRgFUS treatment of dyskinesia of PD * Effectiveness: To determine the level of effectiveness of the ExAblate Transcranial MRgFUS treatment of dyskinesia of PD.Efficacy will be determined utilizing the UPDRS-IV for dyskinesia in PD from examinations at baseline and every 3-Months post-ExAblate treatment. This study is designed as a prospective, single-site, single arm, nonrandomized study. Assessments will be made before and three months after MRgFUS for clinical symptom relief, quality of life (QoL) improvements, and safety of MRgFUS in the treatment of LID. Relative Safety will be evaluated using a common description of Significant Clinical Complications for patients treated in this study. This study will be performed on the 3T MR scanners.
Interventions
DEVICEtranscranial magnetic resonance guided focused ultrasound pallidotomy
Focused ultrasound is an attractive method for non-invasive thermal ablation of soft tissue, including functional brain targets. Treatment begins by acquiring a series of MR images of the target organ. The physician then identifies a target volume in the MR images, and delineates the treatment contours on the images. Therapy planning software calculates the parameters required to effectively treat the defined target volume. During the treatment, an ultrasound transducer generates a point of focused ultrasound energy, called a sonication. The sonication raises the tissue temperature within a well-defined region, enabling neurophysiological assessment in the low range, and thermal coagulation at higher ranges. MR images acquired during sonication provide a quantitative, real-time temperature map of the target area to confirm the location of the sonication and the size of the affected region.
Sponsors
Yonsei University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Men and women, between 20 and 80 years, inclusive * Willing to give consent and able to attend all study visits * Diagnosis of PD as confirmed from clinical history and examination by a movement disorder neurologist * Show unequivocal response to dopaminergic agents, specified as at least 33% improvement in United Parkinson Disease Rating Scale motor subscore (UPDRS-III) and diagnosed as idiopathic PD for more than 5 years. * GPi nucleus of pallidum can be targeted by the ExAblate device. The GPi region of the pallidum must be apparent on MRI such that targeting can be performed with either direct visualization or by measurement from a line connecting the anterior and posterior commissures of the brain. * Able to communicate sensations during the ExAblate MRgFUS treatment * One of dyskinesia rating scores greater than or equal to 2 in UPDRS-IV A-32, 33, & 33. * Stable doses of all medications for 30 days prior to study entry and for the duration of the study. * Inclusion and
Exclusion criteria
have been agreed upon by two members of the medical team.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the unified dyskinesia rating scale (UdysRS) and UPDRS part IV | 3 months after treatment | Dyskinesia will be assessed for each treated PD patient using the UDysRS and UPDRS part IV at baseline before treatment and at post-treatment intervals: 1 week, 1 month, and 3 months, 6 months and 12 months. The validated rating assessment of dyskinesia will be administered by a movement disorder neurologist or physical therapy specialist in an outpatient clinic setting. The primary measure utilized in this protocol will be a reduction in the contralateral upper extremity. Additionally, a total/overall dyskinesia score will be obtained for each patient at each time interval by summing the appendicular and axial scores. |
Countries
South Korea
Outcome results
None listed