This study is a randomized clinical trial evaluating a focused ultrasound treatment for people with advanced Parkinson's disease (PD) who have disabling motor complications and symptoms.
The study uses the Exablate Neuro System, which delivers MR-guided Focused Ultrasound (MRgFUS). This technology focuses ultrasound energy on a specific brain target and generates heat to create a small lesion (ablation) without making a surgical incision.
The target in this study is the Pallidothalamic Tract (PTT), a pathway involved in the abnormal brain circuits that contribute to Parkinson's symptoms and complications.
This study is evaluating whether treating one side of the brain or treating both sides (in separate procedures) provides better outcomes for people with advanced Parkinson's disease who have motor complications and symptoms.
The main outcome measure is the change in the MDS-UPDRS Part III Upper/Lower Extremity (ULE) score at 3 months after first and second side treatment, compared with the respective control groups.
MDS-UPDRS Part III is a standard clinical scale used to assess Parkinson's motor symptoms. ULE score focuses on motor function in the arms and legs. Assessments are performed in the OFF-medication state, meaning Parkinson's medications are temporarily withheld so that the treatment effect can be measured more accurately.
In addition improvement in motor complications will be assessed with MDS-UPDRS Part IV and Patient diaries.
Men or women, age 30 years and older
Subject is able and willing to give informed consent and able to attend all study visits
Subject with a diagnosis of idiopathic PD by UK Brain Bank Criteria as confirmed by a movement disorder neurologist at the site.
Subject is interested in receiving bilateral treatment if they qualify.
3 or 4 on question 2.1 (speech) OR
3 or 4 on question 2.3 (chewing and swallowing) OR
4 on question 2.2 (saliva and drooling).
Subject where there is suspicion that Parkinsonian symptoms are a side effect from neuroleptic medications.
Sequential
Unilateral Exablate MRgFUS Pallidothalamic Tractotomy
Device1st side Exablate MRgFUS Pallidothalamic Tractotomy for Parkinson's Disease
Staged Bilateral Exablate Pallidothalamic Tractotomy
Device2nd side staged Exablate MRgFUS Pallidothalamic Tractotomy for Parkinson's Disease
Best Medical Treatment (BMT)
DrugSubjects will be managed according to conventional therapeutic guidelines (i.e., best medical treatment) for Parkinson's Disease
MDS-UPRDS Part III ULE score in the OFF-medication (unilateral treatment)
Between-group difference (Active Group 1 vs. Control Group 1) in the treatment effect (point change) in the MDS-UPRDS Part III ULE score in the OFF-medication state from Baseline to 3 month. This assessment will be performed by a Movement Disorders neurologist blinded to patient study group allocation.
MDS-UPRDS Part III ULE score in the OFF-medication (bilateral treatment)
Between-group difference (Active Group 2 vs. Control Group 2) in the treatment effect (point change) in the MDS-UPRDS Part III ULE score in the OFF-medication state from Baseline to 3 month. This assessment will be performed by a Movement Disorders neurologist blinded to patient study group allocation.
MDS-UPDRS III Total score in the OFF-medication state
Between-group comparison (Active Group 1 vs Control Group 1) of the treatment effect at Month 3 following Treatment 1 (unilateral) and within-group comparison (Active Group 1) of the treatment effect at all study visits (Month 1, 3 and 6) following Treatment 1 compared to baseline. Between-group comparison (Active Group 2 vs Control Group 2) of the treatment effect at Month 3 following Treatment 2 (staged bilateral) and within-group comparison (Active Group 2) of the treatment effect at all study visits (Month 1, 3, 6 and 12) following Treatment 2 compared to baseline.
MDS-UPDRS Part III OFF ULE score
Between-group comparison (Active Group 1 vs Control Group 1) of the treatment effect at Month 3 following Treatment 1 (unilateral) and within-group comparison (Active Group 1) of the treatment effect at all study visits (Month 1, 3 and 6) following Treatment 1 compared to baseline. Between-group comparison (Active Group 2 vs Control Group 2) of the treatment effect at Month 3 following Treatment 2 (staged bilateral) and within-group comparison (Active Group 2) of the treatment effect at all study visits (Month 1, 3, 6 and 12) following Treatment 2 compared to baseline.
MDS-UPDRS Part III ON Total score
Between-group comparison (Active Group 1 vs Control Group 1) of the treatment effect at Month 3 following Treatment 1 (unilateral) and within-group comparison (Active Group 1) of the treatment effect at all study visits (Month 1, 3 and 6) following Treatment 1 compared to baseline. Between-group comparison (Active Group 2 vs Control Group 2) of the treatment effect at Month 3 following Treatment 2 (staged bilateral) and within-group comparison (Active Group 2) of the treatment effect at all study visits (Month 1, 3, 6 and 12) following Treatment 2 compared to baseline.
MDS-UPDRS Part IV Total score
Between-group comparison (Active Group 1 vs Control Group 1) of the treatment effect at Month 3 following Treatment 1 (unilateral) and within-group comparison (Active Group 1) of the treatment effect at all study visits (Month 1, 3 and 6) following Treatment 1 compared to baseline. Between-group comparison (Active Group 2 vs Control Group 2) of the treatment effect at Month 3 following Treatment 2 (staged bilateral) and within-group comparison (Active Group 2) of the treatment effect at all study visits (Month 1, 3, 6 and 12) following Treatment 2 compared to baseline.
This trial is not recruiting at the moment. You can still explore other options:
