Unilateral and Staged Bilateral Pallidothalamic Tractotomy Using Exablate MRgFUS in Advanced Parkinson's Disease.

Sponsor
InSightec
Study ID
NCT07764874
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Unilateral Exablate MRgFUS Pallidothalamic Tractotomy — DEVICE
    1st side Exablate MRgFUS Pallidothalamic Tractotomy for Parkinson's Disease
  • Staged Bilateral Exablate Pallidothalamic Tractotomy — DEVICE
    2nd side staged Exablate MRgFUS Pallidothalamic Tractotomy for Parkinson's Disease
  • Best Medical Treatment (BMT) — DRUG
    Subjects will be managed according to conventional therapeutic guidelines (i.e., best medical treatment) for Parkinson's Disease

Study Details

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.

Key Dates

First listed
Aug 14, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2029
Completion
Jun 30, 2031

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Active Group 1_Unilateral Exablate Pallidothalamic Tractotomy
    Subjects will undergo the 1st side Exablate procedure (\< 30 days after randomization) and will be followed for 6 months. At their Month 6 visit, subjects will have their re-baseline assessment and undergo staged randomization for the 2nd side treatment.
  • Active Comparator: Control Group 1_Best Medical Treatment (BMT)
    Subjects will have their standard of care (SOC) treatment adjusted to best effect (BMT), and will be followed for 3 months. After their Month 3 visit, subjects will cross over to receive the 1st side treatment and be followed for 6 months. At their Month 6 visit, subjects will have their Treatment 2 re-baseline assessment and undergo staged randomization for the 2nd side treatment.
  • Experimental: Active Group 2_Staged Bilateral Exablate Pallidothalamic Tractotomy
    Subjects will undergo the 2nd side Exablate procedure (\< 30 days after re-baseline assessment, and will be followed for 12 months.
  • Active Comparator: Control Group 2_BMT after Unilateral Exablate Pallidothalamic Tractotomy
    Subjects will continue with their SOC BMT and will be followed for 3 months. After their Month 3 visit, subjects will cross over to receive the 2nd side treatment and be followed for 12 months.
  • Active Comparator: Reference Group_BMT with low SDR
    Subjects will be offered the option to receive best medical treatment and will be followed to capture natural disease progression at approximately the same time schedule as patients in the randomized groups (\~ every 3 - 6 months for up to 24 months).

Primary Outcome Measure

MDS-UPRDS Part III ULE score in the OFF-medication (unilateral treatment) [ Time Frame: 3 Months ]

Central Contacts

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