Clinical Trail of Transcranial MR-guided Focused Ultrasound in the Treatment of Motor Symptoms in Patients with Parkinson' Disease

NCT06639945 | Not Yet Recruiting

• 1 other identifier: XHEC-C-2024-125-2-1
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Randomized, double-blind, self-cross-over control (After the first visit, patients are divided into two groups, randomly receiving real stimulation/placebo stimulation. 10 days later, during the second visit, a cross-over occurs: patients who received real stimulation in the first visit will receive placebo stimulation in the second visit, and vice versa. The grouping situation remains blinded for the patients, TMS analysts, and video analysts.)

Conditions

Parkinson Disease, Idiopathic

Outcome Measures

Primary Outcomes (1)

• UPDRS-III

  Change in Unified Parkinson's Disease Rating Scale (MDS-UPDRS) total score of part III from Day 1 to 1 year. The part III of the MDS-UPDRS assess motor function in best on phase. The score range is 0-132, where a higher score means more severe motor impairment.

  2 weeks and 4 weeks

Secondary Outcomes (2)

• TMS parameters

  2 weeks and 4 weeks

• cortical activation detected by fNIRS

  2 weeks and 4 weeks

Study Arms (2)

Verum stimulation followed by Sham stimulation

EXPERIMENTAL

Device: transcranial MR-guided focused ultrasound

Sham stimulation followed by Verum stimulation

EXPERIMENTAL

Device: transcranial MR-guided focused ultrasound

Interventions

transcranial MR-guided focused ultrasound DEVICE

MRI-guided transcranial focused ultrasound (MRgFUS) combines magnetic resonance imaging (MRI) with focused ultrasound to target specific areas in the brain non-invasively. MRgFUS allows for treatment without surgical incisions, leading to fewer risks and a quicker recovery. MRI provides real-time imaging that helps precisely locate and treat affected brain regions, such as the thalamus or globus pallidus.The procedure allows for continuous monitoring of the treatment effects, enabling adjustments as needed.

Sham stimulation followed by Verum stimulation; Verum stimulation followed by Sham stimulation

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets the clinical probable Parkinson's disease diagnostic criteria proposed by MDS-UPDRS;
• Disease duration of 4 years or less;
• Unmedicated or has been off medication for more than 12 hours, with H\&Y stage ≤ 2.

You may not qualify if:

• History of stroke or seizures, dementia; previous surgical interventions for Parkinson's disease; contraindications for TMS (such as cardiac pacemakers, transcranial implants, and metal implants); severe mental disorders such as depression or psychosis; inability to understand the study procedures; use of antipsychotic medications; pregnancy.

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

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

Central Study Contacts

Lu SONG

CONTACT

13636571889; lu_song@163.com

Zhenguo LIU, Professor

CONTACT

02125077501; liuzhenguo@xinhuamed.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Neurology

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 15, 2024
• Study Start: October 28, 2024
• Primary Completion: July 1, 2025
• Study Completion: October 1, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10