Parkinson Disease Clinical Trial
Official title:
Effect of Transcutaneous Auricular Vagus Nerve Stimulation at 25Hz and 100Hz on Levodopa Responsive and Non-responsive Gait Characteristics in Parkinson's Disease- a Motion Sensor Study
Verified date | October 2023 |
Source | University Medical Centre Ljubljana |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this randomised placebo-controlled trial, the investigators will include 30 PD (Parkinson's disease) patients with HY (Hoehn Yahr stage) >2 and L-dopa unresponsive gait characteristics. Each participant will receive taVNS at 25Hz, taVNS at 100Hz and sham VNS (sVNS). During each stimulation, different gait characteristics will be measured with wearable insertion motion sensors.
Status | Completed |
Enrollment | 30 |
Est. completion date | February 15, 2023 |
Est. primary completion date | February 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - HYstage >2 - L-dopa unresponsive gait characteristics present, preferably with history of freezings Exclusion Criteria: - unable to walk for 50m - unable to follow simple commands due to hearing loss/cognitive impairment |
Country | Name | City | State |
---|---|---|---|
Slovenia | Neurology Department, UMC Ljubljana | Ljubljana |
Lead Sponsor | Collaborator |
---|---|
University Medical Centre Ljubljana |
Slovenia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Arm Swing Velocity | The average velocity of upper extremities in degrees per second as produced by the Mobility Lab software. | This will be measured acutely, e. i. during taVNS/sVNS and compared to baseline measurements. | |
Primary | Arm Range of Motion | The average wrist range of motion in degrees as produced by the Mobility Lab software. | This will be measured acutely, e. i. during taVNS/sVNS and compared to baseline measurements. | |
Primary | Stride Length | The average stride length in m as produced by the Mobility Lab software. | This will be measured acutely, e. i. during taVNS/sVNS and compared to baseline measurements. | |
Primary | Gait Speed | The average speed of gait in m/s as produced by the Mobility Lab software. | This will be measured acutely, e. i. during taVNS/sVNS and compared to baseline measurements. | |
Primary | Arm Range of Motion Asymmetry | The average difference between left and right arm range of motion in degrees as produced by the Mobility Lab software. | This will be measured acutely, e. i. during taVNS/sVNS and compared to baseline measurements. | |
Primary | Anticipatory Postural Adjustment (APA) duration | The average duration of anticipatory postural adjustments in seconds as produced by the Mobility Lab software. | This will be measured acutely, e. i. during taVNS/sVNS and compared to baseline measurements. | |
Primary | APA First step Duration | The average duration of the first detected step in seconds as produced by the Mobility Lab software. | This will be measured acutely, e. i. during taVNS/sVNS and compared to baseline measurements. | |
Primary | APA First Step range of motion | The average range of motion of the first detected step as produced by the Mobility Lab software. | This will be measured acutely, e. i. during taVNS/sVNS and compared to baseline measurements. |
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