Ignite Creation Date:
2024-07-17 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06476912
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-05-03
Brief Title:
Balance Exercise and Vagus Nerve Stimulation on Weight-shifting Control and Ambulation in Parkinson Disease and Anxiety
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Investigating the Effects of Combined Balance Exercise and Vagus Nerve Stimulation on Weight-shifting Control and Ambulation in Patients With Parkinson Disease and Anxiety Under Time and Space Constraints
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Postural balance and anxiety are the two critical factors for reducing independence and quality of life in patients with Parkinsons disease PD Anxiety would deteriorate balance and gait dysfunction Especially relative to non-constraint condition PD patients with anxiety had greater increases in anxiety level and balancegait impairment in time-constraint or space-constraint condition than PD patients without anxiety Presently the appropriate managements for reducing anxiety in patients with PD had not been comprehensively investigated Vagus nerve stimulation VNS is one kind intervention of neuromodulation Previous studies showed that VNS could reduce anxiety level for patients with anxiety syndrome In addition motor training with VNS could reinforce training benefits due to facilitation of brain plasticity However there is no study investigating the effect of VNS on anxiety in PD Also the effect of combined exercise training and VNS on balance and gait in PD has not been studied With the use of behavior performance skin conductance response and electroencephalogram EEG measurement the purpose of the 3-year research project is to investigate the effects of VNS on anxiety and balancegait control in patients with PD In the first year we will investigate the immediate effect of VNS on anxiety and weight-shifting performance in conditions with time constraint and space constraint In the second and third years we will the investigate long-term effects of combined exercise training and VNS on anxiety level weight-shifting and walking performance in time constraint condition and space constraint condition respectively The present project is expected to have significant contributions not only to gain a better insight to neural correlates of anxiety and balance control with VNS but to optimize rehabilitation strategy for PD patients with anxiety
Detailed Description:
Anxiety is one of the most prevalent psychiatric comorbidities in patients with Parkinson disease PD and would deteriorate patients motor symptom and quality of life In particular under space constraint condition the increased anxiety level would impair balance control and ambulation in PD Current pharmacological management and non-pharmacological management for reducing anxiety lack of significant efficacy Vagus nerve stimulation VNS is a neurostimulation intervention for anxiety and transcutaneous vagus nerve stimulation tVNS can be undergone with a transcutaneous electrical nerve stimulator which is an accessible tool in clinic However there is no study investigating tVNS effects on anxiety reduction in PD Therefore the purpose of this study is to investigate the effect of combined balance training and tVNS on reducing anxiety and improving balance and gait in patients with PD especially under space constraint condition
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None