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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: weight-shifting exercise

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 Type: Interventional
• Enrollment (Estimated): 94
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cheng-Ya Huang, PhD; Phone Number: 886-2-3366-8131; Email: rcyhuang@ntu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • School and Graduate Institute of Physical Therapy
    • Contact: Cheng-Ya Huang, PhD; Phone Number: 886-2-33668131

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Mini-Mental State Examination, MMSE < 26 scores
2. depression
3. brain surgery such as deep brain stimulation
4. people with visual impairments

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: active VNS; active vagus nerve stimulation	Other: weight-shifting exercise; lateral weight-shifting balance training and VNS; Other Names: vagus nerve stimulation
Sham Comparator: sham VNS; sham vagus nerve stimulation	Other: weight-shifting exercise; lateral weight-shifting balance training and VNS; Other Names: vagus nerve stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EEG relative power	brain excitability	10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight-shifting tracking error	behavior performance	10 minutes
Skin conductance level	sweat gland activation	10 minutes

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Study Director: Cheng-Ya Huang, PhD, National Taiwan University

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2023
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: May 3, 2024
• First Submitted That Met QC Criteria: June 23, 2024
• First Posted (Actual): June 27, 2024

Study Record Updates

• Last Update Posted (Actual): June 27, 2024
• Last Update Submitted That Met QC Criteria: June 23, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Parkinson disease
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 202301082RIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared due to concerns about participant privacy and confidentiality. Although the data will be de-identified, we prioritize the protection of our participants' personal information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No