Clinical trial NCT05192759: Effect of Theta-Burst Transcranial Magnetic Stimulation (TBS) for Freezing of Gait
Official title: Effect of Theta-Burst Transcranial Magnetic Stimulation (TBS) for Freezing of Gait
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Transcranial Magnetic Stimulation
Freezing of Gait
Keywords: Transcranial Magnetic Stimulation
Freezing of gait
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
First posted: 2022-01-14
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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, and electroencephalography (EEG) record.

In the second day after the last treatment, all the tests, MRI and EEG 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Standing-Start 180° Turn Test (SS-180)
timeFrame: changes from baseline to 1-week post-treatment
Secondary outcomes:
measure: The timed up and go test (TUG)
timeFrame: changes from baseline to 1-week post-treatment
measure: The Freezing of Gait Questionnaire (FOGQ)
timeFrame: changes from baseline to 1-week post-treatment
measure: Unified Parkinson's Disease Rating Scale III (UPDRSIII)
timeFrame: changes from baseline to 1-week post-treatment
measure: Non-motor symptoms questionnaire
timeFrame: changes from baseline to 1-week post-treatment
measure: HAMD (Hamilton Depression Scale)
timeFrame: changes from baseline to 1-week post-treatment
measure: HAMA (Hamilton Anxiety Scale)
timeFrame: changes from baseline to 1-week post-treatment
measure: Pittsburgh sleep quality index (PSQI)
timeFrame: changes from baseline to 1-week post-treatment
Other outcomes:
Locations:
city: Hefei
country: China
facility: Cognitive Neuropsychology Lab Anhui Medical University
state: Anhui
Study officials:
References: