Parkinson Disease
Conditions
Keywords
gait, Therapeutics
Brief summary
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.
Detailed description
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.
Interventions
DEVICETranscutaneous auricular vagus nerve stimulation
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.
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Double (Participant, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. Idiopathic Parkinson's disease (PD), as diagnosed by a neurologist. 2. Hoehn and Yahr stage ≤ 2 during ON medication state. 3. Age between 40 and 80 years old. 4. Mini-Mental State Examination score \>24. 5. Ability to walk at least 60s independently. 6. Stable medication
Exclusion criteria
1. Patients with significant visual impairment or coexisting local or systemic diseases (e.g. osteoarthritis or other neurological conditions) likely to affect gait were excluded from our study. 2. Patients who underwent deep brain stimulation surgery or those with an implanted cardiac pacemaker were also excluded 3. Patients with known or suspected cardiovas-cular disease, uncontrolled hypertension or recent myocardial infarction were also excluded from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Tinetti Balance scores at one day post intervention | Assessed at baseline, one day post intervention. | This indicator mainly reflects the stability of gait. |
| Change from Baseline Velocity at one day post intervention | Assessed at baseline, one day post intervention | The velocity will be recorded in cm/s. |
| Change from Baseline Step length at one day post intervention | Assessed at baseline, one day post intervention. | The step length will be recorded in meters. |
| Change from Baseline arm ROM maximum at one day post intervention | Assessed at baseline, one day post intervention. | The arm ROM maximum will be recorded in degree. |
| Change from Baseline turning average duration velocity at one day post intervention | Assessed at baseline, one day post intervention. | The turning average duration velocity will be recorded in cm/s. |
| Change from Baseline gait cycle at one day post intervention | Assessed at baseline, one day post intervention. | The gait cycle will be recorded in s. |
| Change from Baseline Unified Parkinson's Disease Rating Scale-III at one day post intervention | Assessed at baseline, one day post intervention. | The measure mainly reflects the overall severity of Parkinson's disease motor symptoms. |
| Changes in Tinetti Gait scores at one day post intervention | Assessed at baseline, one day post intervention. | This indicator mainly reflects the stability of posture . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in ΔHbO2 concentration in the brain cortex | Assessed at baseline, one day post intervention. | The ΔHbO2 concentration in the brain cortex will be recorded in oxyhemoglobin. |
Countries
China
Contacts
Primary ContactZhang Kezhong
Outcome results
None listed