Efficacy of Deep-coil Based Repetitive Transcranial Magnetic Stimulation in the Treatment of Parkinson's Disease With Freezing of Gait and Its Neural Regulation Mechanism Study of Resting-state Cerebral Blood Flow

NCT06888778 | Completed

• 1 other identifier: KY2022PJ280
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The protocol for repetitive transcranial magnetic stimulation (rTMS) in treating Parkinson's disease (PD) with freezing of gait (FOG) has not yet established an internationally unified standard, and the heterogeneity of treatment parameters is often the main factor leading to significant differences in efficacy. Based on descriptive analyses and existing data from studies with relatively small sample sizes, the current research primarily focuses on unilateral stimulation targets, without exploring the effectiveness of stimulating the bilateral primary motor centers for lower limbs (M1-LL). Moreover, most studies use figure-of-eight coils or circular coils, while deep-coil stimulation may be more effective for M1-LL. There is still a lack of research employing arterial spin labeling (ASL) imaging to explore the neural mechanisms of resting-state cerebral blood flow (CBF) regulation associated with rTMS treatment for FOG. Therefore, this research project will focus on improving the above - mentioned issues. The high - frequency stimulation of bilateral M1 - LL using a deep - coil (double - cone coil) will be selected. The sample size will be further expanded to evaluate the efficacy of rTMS in treating freezing of gait (FOG). Combined with the three - dimensional arterial spin labeling (3D - ASL) imaging technique, the changes in resting - state cerebral blood flow (CBF) before and after treatment will be analyzed to explore the possible neural mechanisms of rTMS in treating FOG.

Conditions

Parkinson Disease; Freezing of Gait

Keywords

Parkinson disease; Freezing of Gait; Repetitive Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (1)

• Unified Parkinson's Disease Rating Scale

  In this study, Unified Parkinson's Disease Rating Scale(UPDRS) score was used as an assessment tool for PD patients. Four subscales, UPDRS II (0-52 scores), UPDRS III (0-56 scores), UPDRS V (0-5 grades), and UPDRS VI (0-11 grades), were used to assess the condition. The higher the score or grade, the sicker the patient.

  Within 24 hours before treatment, within 24 hours after treatment, and 1 month after treatment

Study Arms (2)

stimulation group

EXPERIMENTAL

participants receive repetitive transcranial magnetic stimulation (rTMS)

Other: repetitive transcranial magnetic stimulation (rTMS)

Non-stimulation group

PLACEBO COMPARATOR

participants receive Non-stimulation:The side of the double cone coil is placed against the scalp, and the target of the coil is stimulated in the direction of air.

Other: Non-stimulation

Interventions

repetitive transcranial magnetic stimulation (rTMS) OTHER

rTMS is a non-invasive brain stimulation technique that stimulates specific brain areas through repeated magnetic pulses to treat depression, anxiety and other mental illnesses, and to study brain function.

stimulation group

Non-stimulation OTHER

participants receive Non-stimulation:The side of the double cone coil is placed against the scalp, and the target of the coil is stimulated in the direction of air.

Non-stimulation group

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meeting the clinical diagnostic criteria for Parkinson's disease established by the Movement Disorder Society (MDS) in 2015.
• Aged between 45 and 70 years old, regardless of gender.
• Regularly taking anti - Parkinson's disease medications for a long time (≥3 years), accompanied by freezing of gait, and with poor efficacy of medications;
• A score of ≥24 on the Mini - Mental State Examination (MMSE).
• Signing the informed consent form and being willing to actively cooperate with the treatment.

You may not qualify if:

• Freezing of gait caused by parkinsonism and parkinson plus syndromes.
• Having a history of central nervous system diseases such as cerebral infarction, cerebral hemorrhage, leukoencephalopathy, and migraine.
• Having been diagnosed with epilepsy or having had epileptic seizures.
• Having undergone craniocerebral surgery, having cerebral aneurysms or arteriovenous malformations, having metal implants in the skull, or having had a cardiac pacemaker implanted.
• Having a history of other mental illnesses or a family history of mental illnesses, such as schizophrenia, bipolar disorder, autism, mental retardation, depression, etc.
• Having received rTMS treatment.
• Severe PD (H\&Y grade ≥ 4).
• Severe organ dysfunction or severe physical diseases.

Sponsors & Collaborators

• Ningbo Medical Center Lihuili Hospital: lead

Study Sites (1)

Ningbo Medical Center Li Huili Hospital, Ningbo, China

Ningbo, Zhejiang, 315100, China

Location

Related Publications (1)

• Rascol O, Brooks DJ, Korczyn AD, De Deyn PP, Clarke CE, Lang AE. A five-year study of the incidence of dyskinesia in patients with early Parkinson's disease who were treated with ropinirole or levodopa. N Engl J Med. 2000 May 18;342(20):1484-91. doi: 10.1056/NEJM200005183422004.

  PMID: 10816186 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director of Neurology

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: March 21, 2025
• Study Start: February 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)