Transcranial Magnetic Stimulation Clinical Trial
Official title:
Effect of Theta-Burst Transcranial Magnetic Stimulation (TBS) for Freezing of Gait
To investigate the treatment effect of Theta-burst Transcranial Magnetic Stimulation (TBS) on patients with freezing of gait (FOG) and the underlying neural mechanism.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | December 30, 2023 |
Est. primary completion date | December 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 85 Years |
Eligibility | Inclusion Criteria: 1. diagnosis of FOG with expertise in movement disorders. 2. the score of item 3 of the FOG questionnaire =1. 3. ongoing treatment with a stable dose of any medication for 2 months. 4. 40 years of age or older. Exclusion Criteria: 1. a history of addiction, psychiatric disorders, or neurological diseases other than PD. 2. focal brain lesions on T1-/T2-weighted fluid-attenuated inversion recovery images. 3. anti-PD medication adjustments during rTMS treatment. 4. history of substance abuse within the past 6 months. 5. nonremovable metal objects in or around the head. 6. previously received rTMS treatment. 7. prior history of seizure or history in first-degree relatives. |
Country | Name | City | State |
---|---|---|---|
China | Cognitive Neuropsychology Lab Anhui Medical University | Hefei | Anhui |
Lead Sponsor | Collaborator |
---|---|
Anhui Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | The timed up and go test (TUG) | 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 whole course are measured. | changes from baseline to 1-week post-treatment | |
Secondary | The Freezing of Gait Questionnaire (FOGQ) | This is an very common clinical motor estimating scale for evaluating FOG symptoms with 6 items and 24' in total. Higher scores indicate worse symptoms. | changes from baseline to 1-week post-treatment | |
Secondary | Unified Parkinson's Disease Rating Scale III (UPDRSIII) | This is an very common clinical motor estimating scale, 14 items and 108' in total. Higher scores indicate worse symptoms. | changes from baseline to 1-week post-treatment | |
Secondary | Non-motor symptoms questionnaire | This is a very common clinical scale with nine domains (30 items). Each item was scored on "severity" range from 1 to 3 and "frequency" range from 1 to 4. Higher scores indicate worse symptoms. | changes from baseline to 1-week post-treatment | |
Secondary | HAMD (Hamilton Depression Scale) | This scale was compiled by Hamilton in 1960, is the most common clinical to assess Depression Scale. In this study, 17 versions were selected, and there were 17 questions. The subjects were assessed for their depression in the past week. Each question scored between 0 and 4 points.Higher scores indicate more depressive symptoms. | changes from baseline to 1-week post-treatment | |
Secondary | HAMA (Hamilton Anxiety Scale) | This scale was compiled by Hamilton in 1959.It was one of the most commonly used scales in psychiatric clinic, including 14 items. It is often used in clinical diagnosis and degree classification of anxiety disorder. The subjects were assessed for their anxiety in the past week. Each question scored between 0 and 4 points. The higher the score, the more symptoms of anxiety. | changes from baseline to 1-week post-treatment | |
Secondary | Pittsburgh sleep quality index (PSQI) | This scale was developed by Dr. Buysse et al., a psychiatrist at the University of Pittsburgh in 1989. The scale is suitable for the evaluation of sleep quality in patients with sleep disorders and mental disorders, as well as for the evaluation of sleep quality in general.Each question scored between 0 and 3 points.The higher the score, the worse sleep quality. | changes from baseline to 1-week post-treatment |
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