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This study is a double blind comparative study examining the effectiveness of the transcutaneous auricular vagus nerve stimulation treatment on Parkinson's disease patients . We hypothesize that treatment using transcutaneous auricular vagus nerve stimulation will improve gait impairments and cortical activity in Parkinson's disease patients.
Patients in the Experimental group underwent seven consecutive daily sessions of transcutaneous auricular vagus nerve stimulation (taVNS, twice daily, 30 minutes each time) , whereas patients in the sham stimulation group underwent seven consecutive daily sessions of sham taVNS. Assessments of gait function, motor symptoms and cortical activity (using Functional near-infrared spectroscopy) were performed two times: at baseline, one day post intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active transcutaneous auricular vagus nerve stimulation | Experimental | For Experimental Arm, active transcutaneous auricular vagus nerve stimulation, Patients underwent seven consecutive daily sessions of taVNS. |
|
| sham transcutaneous auricular vagus nerve stimulation | Sham Comparator | For sham transcutaneous auricular vagus nerve stimulation arm, Sham Comparator, patients underwent seven consecutive daily sessions of sham-taVNS (the electrodes were fixed at the same position without releasing current). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous auricular vagus nerve stimulation | Device | Transcutaneous auricular vagus nerve stimulation was conducted by transcutaneous electrical stimulation therapy instrument to the cymba conchae of left ear in the vicinity of the auricular branch vagus nerve. Stimulation parameters: frequency = 20 Hz; pulse width = 500 μs, twice a day, 30 minutes each time. In the sham stimulation group, the electrodes were fixed at the same position without releasing current. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Velocity at one day post intervention | The velocity will be recorded in cm/s. | Assessed at baseline, one day post intervention |
| Change from Baseline Step length at one day post intervention | The step length will be recorded in meters. | Assessed at baseline, one day post intervention. |
| Change from Baseline arm ROM maximum at one day post intervention | The arm ROM maximum will be recorded in degree. | Assessed at baseline, one day post intervention. |
| Change from Baseline turning average duration velocity at one day post intervention | The turning average duration velocity will be recorded in cm/s. | Assessed at baseline, one day post intervention. |
| Change from Baseline gait cycle at one day post intervention | The gait cycle will be recorded in s. | Assessed at baseline, one day post intervention. |
| Change from Baseline Unified Parkinson's Disease Rating Scale-III at one day post intervention | The measure mainly reflects the overall severity of Parkinson's disease motor symptoms. | Assessed at baseline, one day post intervention. |
| Changes in Tinetti Gait scores at one day post intervention | This indicator mainly reflects the stability of posture . |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in ΔHbO2 concentration in the brain cortex | The ΔHbO2 concentration in the brain cortex will be recorded in oxyhemoglobin. | Assessed at baseline, one day post intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhang Kezhong | Contact | 13770840575 | kezhong_zhang1969@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhang Kezhong | 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 | Recruiting | Nanjing | Jiangsu | 210029 | China |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Double (Participant, Outcomes Assessor)
|
| Assessed at baseline, one day post intervention. |
| Changes in Tinetti Balance scores at one day post intervention | This indicator mainly reflects the stability of gait. | Assessed at baseline, one day post intervention. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |