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Evaluation of the Safety and Effectiveness of Bilateral Exablate Ablation of the Pallidothalamic Tract (PTT) for the Treatment of the Motor Complications of Parkinson's Disease (PD)

A plain-language introduction is being prepared for this study. Open it to read the original description, who can join and how to contact the team.

Testing a treatment or activity · Study reference: NCT04728295

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This registry record was last updated over six months ago, or its update date is missing. Recruitment may have changed. Confirm with the team before making plans.

Open the official registry record ↗

Follow this study

Following participants

Start (reported actual date)
2021-05-14
Main measurements finished (reported actual date)
2024-03-28
Study finished (planned)
2028-12-01

Planned dates can move. A study finishing does not tell us when a paper will be published.

No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.

Changes we have recorded
  • 2026-10-11 — active not recruiting

These are dates we observed a change, not necessarily the dates it happened.

Papers connected to this study

Safety and efficacy of staged, bilateral magnetic resonance-guided focused ultrasound pallidothalamic tractotomy for motor complications of Parkinson's disease: a prospective, multicentre, single-arm trial.
Listed by the registry as research derived from the study · 2026

Participation rules recorded for this study

Age 30 years and over · Does not accept healthy volunteers

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: all

Inclusion Criteria: * Men and women, age 30 years and older, desiring bilateral treatment option with second side staged at 6 months. * 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. * Motor complications of PD on optimum medical treatment * Subject is on a stable dose of all PD medications for 30 days prior to screening visit * Subject is able to communicate sensations during the Exablate procedure. Exclusion Criteria: * Subject where there is suspicion that Parkinsonian symptoms are a side effect from neuroleptic medications. * Subject with significant cognitive impairment as determined by the neuropsychologist. * Subject has 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. * Subject with unstable psychiatric disease, defined as active uncontrolled depressive symptoms, psychosis, delusions, hallucinations, or suicidal ideation * Women of childbearing potential who are pregnant or lactating * Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse * Subject with unstable cardiac status or severe hypertension including: * Documented myocardial infarction within six months of enrollment * Unstable angina on medication * Unstable or worsening congestive heart failure * Left ventricular ejection fraction below the lower limit of normal * History of a hemodynamically unstable cardiac arrhythmia * Cardiac pacemaker * Diastolic BP \> 100 on medication * Subject with history of abnormal bleeding, hemorrhage, or coagulopathy including: * Subject 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. * History of intracranial hemorrhage, multiple strokes, or a stroke within past 6 months * Subjects with intracranial aneurysms requiring treatment or arterial venous malformations (AVMs) requiring treatment * Subject is 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. * Subject with severely impaired renal function with estimated glomerular filtration rate \<30 mL/min/1.73m2 (or per local standards should that be more restrictive) and/or who is on dialysis. * Subjects with a history of seizures within the past year. * Subject with an intracranial brain tumor * Subjects with life-threatening systemic disease that include and not limited to the following will be excluded from the study participation: HIV, liver failure, blood dyscrasias, etc. * Any illness that in the investigator's opinion preclude participation in this study. * Subject with standard contraindications for MR imaging such as implanted metallic devices * Subject who had prior deep brain stimulation of the basal ganglia or thalamus. * Subjects who are unable to tolerate the required prolonged stationary supine position during treatment. * Subject who is participating in another clinical investigation with an active treatment arm in the last 30 days. * Subject who is unable to communicate with the investigator and staff.
Full study name & original research details

Official study title

Evaluation of the Safety and Effectiveness of Bilateral Exablate Ablation of the Pallidothalamic Tract (PTT) for the Treatment of the Motor Complications of Parkinson's Disease (PD)

Original description

Evaluate the Safety and Effectiveness of Staged Bilateral Exablate Ablation of the Pallidothalamic Tract (PTT) for the Treatment of the Motor Complications of Parkinson's Disease (PD).

Further description from the registry

This study is a prospective, open label, single-arm, multi-center clinical trial to establish the safety and effectiveness of bilateral PTTractotomy for the treatment of motor complications in patients with bilateral idiopathic Parkinson's Disease. A maximum of 50 subjects will be treated at up to 10 sites. Subjects will undergo an Exablate index procedure targeting the PTT and will be seen at 1-week,1-, 3-, and 6- months post treatment. At the 6-month visit, subjects will be evaluated for an Exablate procedure on the other side.

Conditions reported: Parkinson Disease

Registry records for this study

Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.

Study type
Interventional
Interventions
Exablate 4000
Phases
NA
Sponsor
InSightec
Start date reported by registry
2021-05-14 (actual)

Registry updated: 2025-02-17 · Status last verified by the registry submitter: 2025-02

Registry records retrieved 2026-10-11 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

No central contact is listed. Check the location contacts or the official registry record.

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

Stanford

Palo Alto, California, United States

Status not reported

Delray Medical Center

Delray Beach, Florida, United States

Status not reported

Rush University Medical Center

Chicago, Illinois, United States

Status not reported

University of Maryland, Baltimore

Baltimore, Maryland, United States

Status not reported

New York University Langone

New York, New York, United States

Status not reported

Weill Cornell Medicine

New York, New York, United States

Status not reported

Neurology, Hospital Universitario HM Puerta del Sur (HM CINAC)

Madrid, Spain

Status not reported

Clínica Universidad de Navarra

Pamplona, Spain

Status not reported

Chang Bing Show Chwan Memorial Hospital

Lugang, Changhua County, Taiwan

Status not reported

Facility not reported

United States

Status not reported

Facility not reported

Spain

Status not reported

Facility not reported

Taiwan

Status not reported

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.