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

NCT06476912 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2024-06-27

No results posted yet for this study

Summary

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.

Conditions

  • Parkinson Disease

Interventions

OTHER

weight-shifting exercise

lateral weight-shifting balance training and VNS

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Cheng-Ya Huang, PhD · National Taiwan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-13
Primary Completion
2024-07-31
Completion
2026-07-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06476912 on ClinicalTrials.gov