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NCT Number: NCT06476912

Balance Exercise and Vagus Nerve Stimulation on Weight-shifting Control and Ambulation in Parkinson Disease and Anxiety

Postural balance and anxiety are the two critical factors for reducing independence and quality of life in patients with Parkinson's 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 balance/gait 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 balance/gait 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.

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Key information

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School and graduate institute of physical therapy

Taipei, Taiwan

Location status: Recruiting

Location contact

Cheng-Ya Huang, PhD

CONTACT

886-2-33668131

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • idiopathic Parkinson's disease
  • Parkinson Anxiety Scale < 13 scores: non-anxiety group or PAS >14 scores: anxiety group
  • subject can walk for 20 meters without assistance
  • no other neurological disease

Exclusion criteria

  • Mini-Mental State Examination, MMSE < 26 scores
  • depression
  • brain surgery such as deep brain stimulation
  • people with visual impairments

Treatment and study plan

weight-shifting exercise

Other

lateral weight-shifting balance training and VNS

Other names: vagus nerve stimulation

Primary outcomes

  1. EEG relative power

    Time frame: 10 minutes

    brain excitability

Secondary outcomes

  1. Weight-shifting tracking error

    Time frame: 10 minutes

    behavior performance

  2. Skin conductance level

    Time frame: 10 minutes

    sweat gland activation

Study contacts

Contact information is provided by the study sponsor or research team.

Cheng-Ya Huang, PhD

CONTACT

[email protected]

886-2-3366-8131

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Jun 27, 2024
Registry last updated
Jun 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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