Effect of Theta-Burst Transcranial Magnetic Stimulation (TBS) for Freezing of Gait
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-85
SponsorAnhui Medical University
About this trial
To investigate the treatment effect of Theta-burst Transcranial Magnetic Stimulation (TBS) on patients with freezing of gait (FOG) and the underlying neural mechanism.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Transcranial Magnetic Stimulation
DeviceThe stimulations were performed by MagStim Rapid2.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: TBS GroupExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
changes from baseline to 1-week post-treatmentSecondary outcomes
1
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.
Time frame
changes from baseline to 1-week post-treatment2
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.
Time frame
changes from baseline to 1-week post-treatment3
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.
Time frame
changes from baseline to 1-week post-treatment4
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.
Time frame
changes from baseline to 1-week post-treatmentSponsors and contacts
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Source ClinicalTrials.gov