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NCT04991831 · ClinicalTrials.gov registry record

A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Thalamotomy for the Treatment of Medication-Refractory Tremor Dominant Idiopathic Parkinson's Disease

A clinical trial of Tremor Associated With Tremor Dominant Parkinson's Disease, sponsored by InSightec.

Recruiting
Registry status
50
Enrollment target
8
Study locations

NCT04991831: Recruiting study of Tremor Associated With Tremor Dominant Parkinson's Disease, sponsored by InSightec.

NCT04991831 is a study of Tremor Associated With Tremor Dominant Parkinson's Disease that is actively recruiting participants, run by InSightec. The registered enrollment target is 50 participants. The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04991831, a study of Tremor Associated With Tremor Dominant Parkinson's Disease, is actively recruiting participants, sponsored by InSightec.

RECRUITING
Registry status
50 participants
Enrollment target
8
Study locations

Study Summary

The objectives of this study are to collect the long-term safety and effectiveness data of performing thalamotomy for tremor dominant Parkinson's Disease (TDPD) using the Exablate Neuro system.

Primary Outcome

This registry will collect the long-term safety data after performing thalamotomy for TDPD using the Exablate Neuro system.

Interventions

  • DEVICE Unilateral thalamotomy

Study Locations (8)

Ohio

  • Cleveland Clinic Foundation - Cleveland
  • Miami Valley Hospital - Fairborn

Florida

  • Miami Neuroscience Institute Baptist Health - Miami

Illinois

  • Rush University - Chicago

Massachusetts

  • Brigham and Women's Hospital - Boston

New York

  • Weill Cornell Medicine - New York

North Carolina

  • Novant Health Brain & Spine Surgery - Huntsville

Scotland

  • University of Dundee - Dundee

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2022-04-28
Est. Completion 2027-12
InSightec

38 total trials

What NCT04991831 shows while recruiting

NCT04991831 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target.

The record links to 1 condition, with Tremor Associated With Tremor Dominant Parkinson's Disease appearing as the primary indexed condition, and to 1 intervention - of which Unilateral thalamotomy is the first listed.

NCT04991831 lists 8 locations in 7 states (Ohio, Florida, Illinois).

Frequently Asked Questions

What is clinical trial NCT04991831 about?

NCT04991831 is a clinical study titled "A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Thalamotomy for the Treatment of Medication-Refractory Tremor Dominant Idiopathic Parkinson's Disease". The objectives of this study are to collect the long-term safety and effectiveness data of performing thalamotomy for tremor dominant Parkinson's Disease (TDPD) using the Exablate Neuro system.

What is the current status of trial NCT04991831?

This trial is currently recruiting. The enrollment target is 50 participants. The study started on 2022-04-28. Estimated completion is 2027-12.

What conditions does trial NCT04991831 study?

This clinical trial studies the following conditions: Tremor Associated With Tremor Dominant Parkinson's Disease.

What interventions are being tested in trial NCT04991831?

The interventions under investigation include: Unilateral thalamotomy (DEVICE).

Who is sponsoring clinical trial NCT04991831?

This trial is sponsored by InSightec, which has 38 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04991831 being conducted?

This trial has 8 study locations across Florida, Illinois, Massachusetts, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT04991831, the US trial registry maintained by the National Library of Medicine. NCT04991831 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.