Effect of Theta-Burst Transcranial Magnetic Stimulation (TBS) for Freezing of Gait

Обзор

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

Подробное описание

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.

Вмешательства

• Устройство Transcranial Magnetic Stimulation
  The stimulations were performed by MagStim Rapid2.

Первичные конечные точки

• The Standing-Start 180° Turn Test (SS-180) [Срок оценки: changes from baseline to 1-week post-treatment]

Вторичные конечные точки (7)

• The timed up and go test (TUG) [Срок оценки: changes from baseline to 1-week post-treatment]
• The Freezing of Gait Questionnaire (FOGQ) [Срок оценки: changes from baseline to 1-week post-treatment]
• Unified Parkinson's Disease Rating Scale III (UPDRSIII) [Срок оценки: changes from baseline to 1-week post-treatment]
• Non-motor symptoms questionnaire [Срок оценки: changes from baseline to 1-week post-treatment]
• HAMD (Hamilton Depression Scale) [Срок оценки: changes from baseline to 1-week post-treatment]
• HAMA (Hamilton Anxiety Scale) [Срок оценки: changes from baseline to 1-week post-treatment]
• Pittsburgh sleep quality index (PSQI) [Срок оценки: changes from baseline to 1-week post-treatment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Cognitive Neuropsychology Lab Anhui Medical University — Хэфэй

Публикации

• 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

Идентификаторы

NCT: NCT05192759 · AHMU-TMS-FOG

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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