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

NCT06259708 | Completed

• 1 other identifier: H23-00480
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease

Keywords

Low intensity focused ultrasound; Parkinsons disease; Tremor; Zona incerta

Outcome Measures

Primary Outcomes (3)

• Tremor

  Finger displacement (angle \[deg\]).

  At 50Hz for 40 minutes 30 minutes after intervention

• Tremor

  Finger acceleration (mm/s\^2)

  At 50Hz for 40 minutes 30 minutes after intervention

• Functional connectivity

  fMRI

  Once before and once immediately after intervention

Study Arms (2)

Vim first

EXPERIMENTAL

Participants assigned to this arm get LIFU stimulation in the Vim before the ZI.

Device: Low intensity focused ultrasound

ZI first

EXPERIMENTAL

Participants assigned to this arm get LIFU stimulation in the Vim before the ZI.

Device: Low intensity focused ultrasound

Interventions

Low intensity focused ultrasound DEVICE

Sonication with low intensity focused ultrasound in two deep brain structures (ZI and Vim).

Vim first; ZI first

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• Focused Ultrasound Foundation: collaborator

Study Sites (1)

University of British Columbia, DMCBH

Vancouver, British Columbia, V6T 1Z3, Canada

Location

MeSH Terms

Conditions

Parkinson Disease; Tremor

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The investigators will use a crossover design for this study as it requires fewer participants and removes variance between participants in the outcomes that are irrelevant to the stimulation type in comparison to other designs where each participant only receives one stimulation. All participants receive all the stimulation types (Vim-LIFU and ZI-LIFU), but the order in which they get the stimulation types is randomized.

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: February 14, 2024
• Study Start: March 1, 2024
• Primary Completion: June 17, 2025
• Study Completion: June 17, 2025
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

CA (1)