Using Low Intensity Focused Ultrasound to Modulate Deep Brain Areas for Tremor Control in Parkinson's Disease Patients.

February 13, 2024 updated by: Martin McKeown, University of British Columbia

Effectiveness of Targeting the Zona Incerta (ZI) for Tremor Control in Parkinson's Disease Patients

Researchers have found that a treatment called Magnetic Resonance guided Focused Ultrasound (MRgFUS) can effectively reduce tremors in patients with essential tremor (ET) and Parkinson's disease (PD). They noticed that ET patients initially responded better to the treatment than PD patients, but by the end of the treatment, both groups showed similar improvement. The study also suggested that targeting a specific area of the brain called the Zona Incerta (ZI) may be more beneficial for PD patients. Based on these findings, the investigators plan to use low-intensity focused ultrasound to directly modulate the ZI area and investigate the mechanisms of reduced tremors in PD patients. The investigators will also compare the effectiveness of this approach with the current target, the ventral intermediate nucleus (Vim) of the thalamus. The investigators will use a simulation model to determine the best ultrasound parameters for this new approach and will also examine the impact of the treatment on the brain's network activity using functional Magnetic Resonance Imaging. Success of this project may lay the foundation for finding a more effective target for MRgFUS treatment of PD tremor.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 1Z3
        • University of British Columbia, DMCBH
        • Contact:
        • Principal Investigator:
          • Martin J McKeown, MD, FRCPC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Confirmed diagnosis of Parkinson's disease
  • Resting tremor score (MDS-UPDRS III 3.17 Rest Tremore Amplitude (RUE or LUE)) ≥ 2
  • Between the ages of 40-80 years
  • Hoehn and Yahr stage between 1-3 (mild to moderate PD) in the "ON" state
  • Patients who are willing to have a partial (~8 cm diameter circular area above the ear) hair shaving.

Exclusion Criteria:

  • Atypical Parkinsonism
  • History of essential tremor
  • Dementia preventing informed consent
  • Change in Parkinson's medication with the last 2 weeks
  • Neurological disease other than PD, including Alzheimer's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, a brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma
  • Unstable medical conditions or serious disease/conditions (e.g., cancer undergoing active treatment, poorly controlled diabetes)
  • Concurrent treatment for PD with Duodopa
  • Concurrent treatment for PD with deep brain stimulation (DBS)
  • Thickness of the temporal bone < 7 mm
  • Individuals should also not participate if they have any of the following contraindications for undergoing fMRI scanning:
  • Cardiac pacemaker, wires, or defibrillator
  • Metal in eye or orbit, including the history of any eye injury involving metal fragments and increased risk due to (history of) working as a metal worker (grinding, machining, or welding)
  • Ferromagnetic aneurysm clip
  • Possibility of pregnancy
  • Artificial heart valve
  • Ear or eye implant, including cochlear implant
  • Brain aneurysm clip
  • Implanted drug infusion pump
  • Electrical stimulator to nerves or bones
  • Coil, catheter, or filter in any blood vessel
  • Orthopedic hardware (artificial joint, plate, screw, rod)
  • Other metallic prostheses
  • Shrapnel, bullets, or other metal fragments
  • Surgery, piercings or tattoos (including tattooed eyeliner) in the last six weeks
  • Medication releasing skin patches (i.e. nicotine, birth control, nitroglycerine)
  • History of claustrophobia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vim first
Participants assigned to this arm get LIFU stimulation in the Vim before the ZI.
Device: Low intensity focused ultrasound
Sonication with low intensity focused ultrasound in two deep brain structures (ZI and Vim).
Experimental: ZI first
Participants assigned to this arm get LIFU stimulation in the Vim before the ZI.
Device: Low intensity focused ultrasound
Sonication with low intensity focused ultrasound in two deep brain structures (ZI and Vim).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tremor
Time Frame: At 50Hz for 40 minutes 30 minutes after intervention
Finger displacement (angle [deg]).
At 50Hz for 40 minutes 30 minutes after intervention
Tremor
Time Frame: At 50Hz for 40 minutes 30 minutes after intervention
Finger acceleration (mm/s^2)
At 50Hz for 40 minutes 30 minutes after intervention
Functional connectivity
Time Frame: Once before and once immediately after intervention
fMRI
Once before and once immediately after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

Focused Ultrasound Foundation

Investigators

  • Principal Investigator: Hongchae Baek, PhD, Food and Drugs Administration
  • Principal Investigator: Soojin Lee, PhD, University of British Columbia
  • Principal Investigator: Martin J. McKeown, MD, FRCPC, University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

January 26, 2024

First Submitted That Met QC Criteria

February 13, 2024

First Posted (Actual)

February 14, 2024

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H23-00480

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson Disease

Clinical Trials on Low intensity focused ultrasound

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe