NCT05192759

Brief Summary

To investigate the treatment effect of Theta-burst Transcranial Magnetic Stimulation (TBS) on patients with freezing of gait (FOG) and the underlying neural mechanism.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
33mo left

Started Nov 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Nov 2021Dec 2028

Study Start

First participant enrolled

November 22, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 3, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 14, 2022

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2028

Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

7.1 years

First QC Date

January 3, 2022

Last Update Submit

November 17, 2025

Conditions

Transcranial Magnetic StimulationFreezing of Gait

Keywords

Transcranial Magnetic StimulationFreezing of gait

Outcome Measures

Primary Outcomes (1)

  • The Standing-Start 180° Turn Test (SS-180)

    The participants walk for a distance of five meters from a sitting position and come back to the chair after turning 180° around a traffic cone in a 0.7 m × 0.7 m target box.The time and number of steps during the 180° turn (SS180) are measured.

    changes from baseline to 1-week post-treatment

Secondary Outcomes (7)

  • The timed up and go test (TUG)

    changes from baseline to 1-week post-treatment

  • The Freezing of Gait Questionnaire (FOGQ)

    changes from baseline to 1-week post-treatment

  • Unified Parkinson's Disease Rating Scale III (UPDRSIII)

    changes from baseline to 1-week post-treatment

  • Non-motor symptoms questionnaire

    changes from baseline to 1-week post-treatment

  • HAMD (Hamilton Depression Scale)

    changes from baseline to 1-week post-treatment

  • +2 more secondary outcomes

Study Arms (1)

TBS Group

EXPERIMENTAL

Participants will receive active transcranial magnetic stimulation (TMS) daily for 1 week

Device: Transcranial Magnetic Stimulation

Interventions

Transcranial Magnetic StimulationDEVICE

The stimulations were performed by MagStim Rapid2.

TBS Group

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of FOG with expertise in movement disorders.
  • the score of item 3 of the FOG questionnaire ≥1.
  • ongoing treatment with a stable dose of any medication for 2 months.
  • years of age or older.

You may not qualify if:

  • a history of addiction, psychiatric disorders, or neurological diseases other than PD.
  • focal brain lesions on T1-/T2-weighted fluid-attenuated inversion recovery images.
  • anti-PD medication adjustments during rTMS treatment.
  • history of substance abuse within the past 6 months.
  • nonremovable metal objects in or around the head.
  • previously received rTMS treatment.
  • prior history of seizure or history in first-degree relatives.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cognitive Neuropsychology Lab Anhui Medical University

Hefei, Anhui, 230032, China

RECRUITING

Related Publications (1)

  • Yu L, Han J, Chen X, Hu L, Wang M, Zhu M, Cheng J, Liu P, Fang L, Li Y, Wu J, Zhao X, Sun J, Ji GJ, Wang K, Ye R, Hu P. Regional-specific structural and functional changes of posterior cerebellar vermis across different stages of Parkinson's disease with gait dysfunction. NPJ Parkinsons Dis. 2025 Jul 12;11(1):208. doi: 10.1038/s41531-025-01065-1.

    PMID: 40651960DERIVED

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Central Study Contacts

Gong-Jun JI, Ph.D.

CONTACT

+8655162923704jigongjun@163.com

Jinmei Sun, M.S.

CONTACT

+8615856381782sunjinmei0628@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Dept of Neurology & Medical Psychology, Director, Cognitive Neuropsychology Lab, PRC

Study Record Dates

First Submitted

January 3, 2022

First Posted

January 14, 2022

Study Start

November 22, 2021

Primary Completion (Estimated)

December 30, 2028

Study Completion (Estimated)

December 30, 2028

Last Updated

November 19, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)