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

NCT06476912 | Recruiting

• 1 other identifier: 202301082RIND
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Parkinson disease

Outcome Measures

Primary Outcomes (1)

• EEG relative power

  brain excitability

  10 minutes

Secondary Outcomes (2)

• Weight-shifting tracking error

  10 minutes

• Skin conductance level

  10 minutes

Study Arms (2)

active VNS

EXPERIMENTAL

active vagus nerve stimulation

Other: weight-shifting exercise

sham VNS

SHAM COMPARATOR

sham vagus nerve stimulation

Other: weight-shifting exercise

Interventions

weight-shifting exercise OTHER

lateral weight-shifting balance training and VNS

Also known as: vagus nerve stimulation

active VNS; sham VNS

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

School and graduate institute of physical therapy

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Vagus Nerve Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics

Study Officials

• Cheng-Ya Huang, PhD

  National Taiwan University

  STUDY DIRECTOR

Central Study Contacts

Cheng-Ya Huang, PhD

CONTACT

886-2-3366-8131; rcyhuang@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: June 27, 2024
• Study Start: September 13, 2023
• Primary Completion: July 31, 2024
• Study Completion (Estimated): July 31, 2026
• Last Updated: June 27, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)