Effect of Theta-Burst Transcranial Magnetic Stimulation (TBS) for Freezing of Gait
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcranial Magnetic Stimulation.
- Who it may be relevant to
- Registry conditions: Transcranial Magnetic Stimulation, Freezing of Gait. Basic parameters: 40 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
To investigate the treatment effect of Theta-burst Transcranial Magnetic Stimulation (TBS) on patients with freezing of gait (FOG) and the underlying neural mechanism.
Detailed description
This was a open-label clinical trial to assess the efficacy and underlying neural mechanism of TBS among patients with FOG. Forty patients with FOG were treated with TBS for 1 week.
Before the TBS treatment, the Freezing of Gait Questionnaire, the Timed up and go test, the Standing Start 180° Turning Test, the Unified Parkinson's Disease Rating Scale, and the Non-motor Symptom Scale, the Pittsburgh sleep quality index were obtained by a trained investigator to assess baseline severity. The patients had receiving a battery measure of neuropsychological tests(mini-mental state examination, Montreal cognitive assessment, digital span test, verbal fluency test, Hamilton depression/anxiety scale) and magnetic resonance imaging (MRI) scan in multimodalities, electroencephalography (EEG) record and fNIRS.
In the second day after the last treatment, all the tests, MRI 、EEG and fNIRS were reassessed. Patients were instructed to focus their answers on the past 1 week.
The clinical symptom and cognition of participants were followed in one month and two month after the last treatment.
Interventions
- Device Transcranial Magnetic Stimulation
The stimulations were performed by MagStim Rapid2.
Primary outcome measures
- The Standing-Start 180° Turn Test (SS-180) [Time frame: changes from baseline to 1-week post-treatment]
Secondary outcome measures (7)
- The timed up and go test (TUG) [Time frame: changes from baseline to 1-week post-treatment]
- The Freezing of Gait Questionnaire (FOGQ) [Time frame: changes from baseline to 1-week post-treatment]
- Unified Parkinson's Disease Rating Scale III (UPDRSIII) [Time frame: changes from baseline to 1-week post-treatment]
- Non-motor symptoms questionnaire [Time frame: changes from baseline to 1-week post-treatment]
- HAMD (Hamilton Depression Scale) [Time frame: changes from baseline to 1-week post-treatment]
- HAMA (Hamilton Anxiety Scale) [Time frame: changes from baseline to 1-week post-treatment]
- Pittsburgh sleep quality index (PSQI) [Time frame: changes from baseline to 1-week post-treatment]
Eligibility criteria
Inclusion criteria
- 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.
- 40 years of age or older.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Cognitive Neuropsychology Lab Anhui Medical University — Hefei
Publications
- 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 40651960
Identifiers
NCT: NCT05192759 · AHMU-TMS-FOG