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

NCT ID: NCT06476912

Last Updated: 2024-06-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-13
• Study Completion Date: 2026-07-31

Brief 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.

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

active VNS

active vagus nerve stimulation

Group Type: EXPERIMENTAL

weight-shifting exercise

Intervention Type: OTHER

lateral weight-shifting balance training and VNS

sham VNS

sham vagus nerve stimulation

Group Type: SHAM_COMPARATOR

weight-shifting exercise

Intervention Type: OTHER

lateral weight-shifting balance training and VNS

Interventions

weight-shifting exercise

lateral weight-shifting balance training and VNS

Intervention Type: OTHER

Other Intervention Names

vagus nerve stimulation

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cheng-Ya Huang, PhD

Role: STUDY_DIRECTOR

National Taiwan University

Locations

School and graduate institute of physical therapy

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Cheng-Ya Huang, PhD

Role: CONTACT

rcyhuang@ntu.edu.tw

886-2-3366-8131

Facility Contacts

Cheng-Ya Huang, PhD

Role: primary

886-2-33668131

Other Identifiers

202301082RIND

Identifier Type: -

Identifier Source: org_study_id