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This study is a double-blinded randomized study examining the efficacy of the double-site (M1+SMA) repetitive transcranial magnetic stimulation on Freezing of Gait (FOG) in patients with Parkinson's disease. The investigators hypothesize that treatment using magnetic stimulation on double site (including M1-LL and SMA) will improve FOG and gait symptoms in patients with Parkinson's disease.
Patients in the double-site group underwent ten sessions of double-site high frequency rTMS over the bilateral primary motor cortex of the lower leg and supplementary motor area, whereas patients in the single-site group underwent ten sessions of single-site active magnetic stimulation with high frequency rTMS over the bilateral primary motor cortex of the lower leg. In addition, patients in the sham group underwent 10 sessions of sham rTMS on bilateral primary motor cortex of the lower leg. Assessments of FOG severity, gait, motor symptoms, excitability of cortex motor (using transcranial magnetic stimulation), plasma indicators and multimodal magnetic resonance were performed three times: at baseline, one day post intervention, one month post intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| double-site high frequency rTMS over the bilateral M1 of the lower leg and SMA | Experimental | Patients in the Experimental group underwent ten sessions of double-site high frequency rTMS over the bilateral M1 of the lower leg and SMA. |
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| single-site high frequency rTMS over the bilateral M1 of the lower leg | Active Comparator | Patients in the Active Comparator group underwent ten sessions of single-site active magnetic stimulation with high frequency rTMS over the bilateral M1 of the lower leg. |
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| sham magnetic stimulation on the bilateral M1 of the lower leg | Sham Comparator | Patients in the Sham Comparator group underwent ten sessions of double sham rTMS on the bilateral M1 of the lower leg. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SMA+M1 Transcranial Magnetic Stimulation | Device | The M1 stimulation session consisted 40 trains of 10-Hz rTMS with the protocol of 5s train session and 25s intertrain intervals. There were 4000 pulses per day for M1-LL (unilateral stimulation 2000 pulses). For SMA stimulation, a 5s burst of 10Hz rTMS was repeated 20 times (1000 pulse, 20 minutes' duration). Patients in the Experimental group underwent ten sessions of double-site high frequency rTMS over the bilateral primary motor cortex (M1) of the lower leg and supplementary motor area (SMA). |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of Freezing of Gait severity | The Freezing of Gait questionnaire will be used to quantify the frequency and severity of FOG. The score will be compared to the baseline. The minimum and maximum values of the FOGQ are 0 and 24. A higher score means a worse outcome. The differences in FOGQ scores before and after treatment can be used to evaluate the effect of TMS treatment. | Assessed at baseline, one day post intervention, one month post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Freezing of Gait severity assessment | The New Freezing of Gait questionnaire will be used to quantify the frequency and severity of FOG. The score will be compared to the baseline. The minimum and maximum values of the NFOGQ are 0 and 28. A higher score means a worse outcome. The differences in NFOGQ scores before and after treatment can be used to evaluate the effect of TMS treatment. | Assessed at baseline, one day post intervention, one month post intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kezhong Zhang | The First Affiliated Hospital with Nanjing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | 210029 | China |
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| M1 Transcranial Magnetic Stimulation | Device | The M1 stimulation session consisted 40 trains of 10-Hz rTMS with the protocol of 5s train session and 25s intertrain intervals. There were 4000 pulses per day for M1-LL (unilateral stimulation 2000 pulses). Patients in the Active Comparator group underwent ten sessions of single-site active magnetic stimulation with high frequency rTMS over the bilateral M1 of the lower leg. |
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| Sham Transcranial Magnetic Stimulation | Device | Patients in the Sham Comparator group underwent 10 sessions of double sham rTMS on M1 of the lower leg. |
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| Changes of Movement Disorder Society Unified Parkinson's disease rating scale part III (MDS-UPDRS-III) | The measure mainly reflects the overall severity of Parkinson's disease motor symptoms and non-motor symptoms. The minimum value is 0 and the maximum value is 132. A higher score means a worse outcome. The score will be compared to the baseline. The differences in MDS-UPDRS III part scores before and after treatment can be used to evaluate the effect of TMS treatment. | Assessed at baseline, one day post intervention, one month post intervention |
| Changes of Gait speed | Gait speed (m/s) was evaluated at baseline, one day post intervention, one month post intervention using a portable Inertial Measurement Unit system during a 5-m timed Up-and-Go (TUG) test. The differences in gait speed before and after treatment can be used to evaluate the effect of TMS treatment. | Assessed at baseline, one day post intervention, one month post intervention |
| Changes of Stride length | Stride length (cm) was evaluated at baseline, one day post intervention, one month post intervention using a portable Inertial Measurement Unit system during a 5-m timed Up-and-Go (TUG) test. The differences in stride length before and after treatment can be used to evaluate the effect of TMS treatment. | Assessed at baseline, one day post intervention, one month post intervention |
| Changes in Short-interval intracortical inhibition (SICI), intracortical facilitation (ICF) and short-interval intracortical facilitation (SICF) | Short-interval intracortical inhibition (SICI), intracortical facilitation (ICF) and short-interval intracortical facilitation (SICF) are conducted by TMS devices to assess the cortical excitation and inhibition. SICI was assessed with a subthreshold conditioning stimulus (80% RMT) and a supra-threshold test stimulus (1 mV MEP) with 2ms, 3ms, 4ms interstimulus interval between conditioning and test stimuli. ICF was assessed with a subthreshold conditioning stimulus (80% RMT) and a supra-threshold test stimulus (1 mV MEP) with 10, 12, 15 ms interstimulus interval between conditioning and test stimuli. For SICF, a subthreshold first stimulus (S1) intensity was set at 1 mV and a subsequent suprathreshold second stimulus (S2) intensity was set at RMT. Interstimulus intervals were 1.0 to 5.0 milliseconds with increments of 0.5 millisecond.The differences in SICI, ICF and SICF before and after treatment can be used to evaluate the effect of TMS treatment. | Assessed at baseline, one day post intervention |
| Changes in functional connectivity in the brain cortex | The functional connectivity in the brain cortex will be recorded by functional MRI. The differences in brain regions' functional connectivity before and after treatment can be used to evaluate the effect of TMS treatment. | Assessed at baseline, one day post intervention |
| Changes in brain structure | Studying the brain structure among groups. The differences in brain microstructure before and after treatment can be used to evaluate the effect of TMS treatment. | Assessed at baseline, one day post intervention |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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