A Study to Evaluate the Safety and Efficacy of ExAblate Subthalomotomy for the Treatment of Parkinson's Disease Motor Features

NCT03454425 | Completed DMC

• 1 other identifier: PD010
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Parkinson's Disease; ExAblate; MRgFUS; Sub-Thalamotomy

Outcome Measures

Primary Outcomes (2)

• Efficacy - MDS-UPDRS

  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

  Baseline to 4 months post treatment

• Safety - Adverse Events

  To evaluate the incidence and severity of adverse events (AE/AEs) associated with ExAblate subthalamotomy for the treatment of PD motor features.

  Baseline to 4 Months post treatment

Secondary Outcomes (12)

• MDS-UPDRS III ON-medication

  Baseline to Month 4 post treatment

• MDS-UPDRS III OFF-medication

  Baseline to Month 4 post treatment

• MDS-UPDRS III- Contralateral ON-medication

  Baseline to Month 4 post treatment

• MDS-UPDRS III

  Baseline to Month 4 post treatment

• MDS-UPDRS II

  Baseline to Month 4 post treatment

Study Arms (2)

Exablate Subthalamotomy

EXPERIMENTAL

Exablate treatment for Parkinson's Disease Motor Features

Device: Exablate Subthalamotomy

Sham ExAblate Subthalamotomy

SHAM COMPARATOR

Device: Sham Exablate Subthalamotomy

Interventions

Exablate Subthalamotomy DEVICE

ExAblate Subthalomotomy for the Treatment of Parkinson's Disease Motor Features

Also known as: MRgFUS, Subthalamotomy

Exablate Subthalamotomy

Sham Exablate Subthalamotomy DEVICE

Sham ExAblate Subthalomotomy for the Treatment of Parkinson's Disease Motor Features

Sham ExAblate Subthalamotomy

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women age 30 years or older
• Subjects who are able and willing to give consent and able to attend all study visits.
• Subjects with a diagnosis of PD by UK Brain Bank Criteria as confirmed by a movement disorder neurologist at the site.
• Predominant motor features/disability from one side of the body (i.e asymmetry index \> 1.5) as determined by a movement disorders neurologist.
• 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.
• No major changes in pharmacological regime for PD should be done for the 30 days prior to procedure.
• Topographic coordinates of the subthalamic nucleus are localizable on MRI so that it can be targeted by the ExAblate device.

You may not qualify if:

• Hoehn and Yahr stage in the ON medication state of 2.5 or greater
• Presence of severe dyskinesia as noted by a score of 3 or 4 on questions 4.1 and 4.2 of the MDS-UPDRS.
• Presence of other central neurodegenerative disease suspected on neurological examination. These include: multisystem atrophy, progressive supranuclear palsy, corticobasal syndrome, dementia with Lewy bodies, and Alzheimer's disease.
• Any suspicion that Parkinsonian symptoms are a side effect from neuroleptic medications.
• Subjects who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia
• Presence of significant cognitive impairment defined as score ≤ 21 on the Montreal Cognitive Assessment (MoCA) or Mattis Dementia Rating Scale of 120 or lower.
• Unstable psychiatric disease, defined as active uncontrolled depressive symptoms, psychosis, delusions, hallucinations, or suicidal ideation. Subjects with stable, chronic anxiety or depressive disorders may be included provided their medications have been stable for at least 60 days prior to study entry and if deemed appropriately managed by the site neuropsychologist
• Subjects with significant depression as determined following a comprehensive assessment by a neuropsychologist. Significant depression is being defined quantitatively as a score of greater than 14 on the Beck Depression Inventory.
• Legal incapacity or limited legal capacity as determined by the neuropsychologist
• Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse as defined by the criteria outlined in the DSM-IV as manifested by one
• Subjects with unstable cardiac status including
• Severe hypertension (diastolic BP \> 100 on medication).
• History of or current medical condition resulting in abnormal bleeding and/or coagulopathy.
• Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage (e.g. Avastin) within one month of focused ultrasound procedure
• Subjects with risk factors for intraoperative or postoperative bleeding as indicated by: platelet count less than 100,000 per cubic millimeter, a documented clinical coagulopathy, or INR coagulation studies exceeding the institution's laboratory standard

Sponsors & Collaborators

• InSightec: lead

Study Sites (1)

Hospital Universitario HM Puerta Del Sur. CINAC

Móstoles, Madrid, 28938, Spain

Location

Related Publications (3)

• Martinez-Fernandez R, Natera-Villalba E, Manez Miro JU, Rodriguez-Rojas R, Marta Del Alamo M, Pineda-Pardo JA, Ammann C, Obeso I, Mata-Marin D, Hernandez-Fernandez F, Gasca-Salas C, Matarazzo M, Alonso-Frech F, Obeso JA. Prospective Long-term Follow-up of Focused Ultrasound Unilateral Subthalamotomy for Parkinson Disease. Neurology. 2023 Mar 28;100(13):e1395-e1405. doi: 10.1212/WNL.0000000000206771. Epub 2023 Jan 11.

  PMID: 36631272 DERIVED

• Rodriguez-Rojas R, Pineda-Pardo JA, Manez-Miro J, Sanchez-Turel A, Martinez-Fernandez R, Del Alamo M, DeLong M, Obeso JA. Functional Topography of the Human Subthalamic Nucleus: Relevance for Subthalamotomy in Parkinson's Disease. Mov Disord. 2022 Feb;37(2):279-290. doi: 10.1002/mds.28862. Epub 2021 Dec 3.

  PMID: 34859498 DERIVED

• Martinez-Fernandez R, Manez-Miro JU, Rodriguez-Rojas R, Del Alamo M, Shah BB, Hernandez-Fernandez F, Pineda-Pardo JA, Monje MHG, Fernandez-Rodriguez B, Sperling SA, Mata-Marin D, Guida P, Alonso-Frech F, Obeso I, Gasca-Salas C, Vela-Desojo L, Elias WJ, Obeso JA. Randomized Trial of Focused Ultrasound Subthalamotomy for Parkinson's Disease. N Engl J Med. 2020 Dec 24;383(26):2501-2513. doi: 10.1056/NEJMoa2016311.

  PMID: 33369354 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 5, 2018
• Study Start: February 27, 2018
• Primary Completion: June 15, 2020
• Study Completion: June 15, 2020
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

ES (1)