NCT06562569

Brief Summary

More than 110,000 US Veterans living with Parkinson's disease (PD) currently receive PD-related care and services from the VA. Fall prevention is a priority for Veterans living PD. Gait disturbances are a major cause for functional dependence and the largest risk factor for falls, institutionalization, and death in PD. This SPiRE addresses the need to advance nonpharmacological rehabilitative health care of Veterans and maximizing functional outcomes by developing a non-invasive, neuromodulatory transcutaneous cervical Vagal Nerve Stimulation as an at-home intervention to improve gait and balance. This pilot clinical trial will assist with future efforts and priorities of the VA to prolong independent living and quality of life by minimizing gait and balance dysfunction experienced by Veterans living with PD.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
11mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Mar 2026Apr 2027

First Submitted

Initial submission to the registry

August 16, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 20, 2024

Completed
1.5 years until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

August 16, 2024

Last Update Submit

April 20, 2026

Conditions

Parkinson's Disease

Keywords

vagal nerve stimulationgaitneuromodulationFreezing of gaitVeteran

Outcome Measures

Primary Outcomes (1)

  • Stride Length

    Quantitative gait analysis will be performed during a 15-meter instrumented 2-min walk test (2MWT) using the APDM Mobility Lab

    baseline and 4 weeks

Study Arms (3)

Group 1

EXPERIMENTAL

Vagal nerve stimulation at an intensity under 10 units. Participants will self-administered at this intensity for 2 minutes each day over 4 weeks.

Device: non-invasive cervical vagal nerve stimulation ncVNS

Group 2

EXPERIMENTAL

Vagal nerve stimulation at the highest intensity tolerated by the participant. Participants will self-administered at this intensity for 12 minutes each day over 4 weeks.

Device: non-invasive cervical vagal nerve stimulation ncVNS

Group 3

NO INTERVENTION

This group will not receive any stimulation. Participants will receive their treatment as usual.

Interventions

non-invasive cervical vagal nerve stimulation ncVNSDEVICE

The ncVNS device is a rechargable, handheld device that generate a proprietary frequency-modulated electrical stimulus at low voltage (max 24V) with a max current output of 60mA. The signal consists of 1ms bursts of 5kHz sine waves repeated at 25Hz. Two stainless steel contact surfaces coated with conductive gel deliver the stimulus to the neck in the vicinity of the vagus nerve.

Also known as: VNS
Group 1Group 2

Eligibility Criteria

Age50 Years - 88 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parkinson's disease, as diagnosis by a VA neurologist
  • HY stages 2-3
  • Self-report Freezing of Gait
  • Able to ambulate for 2-min without an assistive device
  • Parkinson's disease medications are stable for 4-weeks and expected to be on stable medications for duration of the study

You may not qualify if:

  • Lack of decision-making capacity
  • Prescribed centrally acting anticholinergics (e.g., amitriptyline) or cholinesterase inhibitors
  • Musculoskeletal or additional neurological conditions that negatively impact gait and balance
  • Spine or LE surgery within the past year
  • Known or suspected:
  • severe atherosclerotic cardiovascular disease
  • severe carotid artery disease
  • congestive heart failure
  • known severe coronary artery disease or prior myocardial infarction
  • Abnormal baseline electrocardiogram within last year
  • Previous vagotomy
  • Implanted metal cervical spine hardware, other metallic implants or implantable medical devices such as DBS
  • History of syncope or seizures (within the last 2 years)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, 60141-3030, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Sandra L. Kletzel, PhD BA

    Edward Hines Jr. VA Hospital, Hines, IL

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandra L Kletzel, PhD BA

CONTACT

(708) 202-5735Sandra.Kletzel@va.gov

Alexandria N Umbarger, BS

CONTACT

(708) 998-8213alexandria.umbarger@va.gov

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Veterans will be randomized to one of two groups that will receive vagal nerve stimulation
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2024

First Posted

August 20, 2024

Study Start

March 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)