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Neuromodulation

Non-Invasive Vagal Nerve Stimulation for Parkinson's Disease

N/A

Waitlist Available

Led By Sandra L. Kletzel, PhD BA

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Self-report Freezing of Gait

Parkinson's disease diagnosed by a VA neurologist

Must not have

Lack of decision-making capacity

Spine or LE surgery within the past year

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 4 weeks

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to improve gait and balance in Veterans with Parkinson's disease using a non-invasive neck stimulation technique. Gait disturbances are a major issue for these individuals and can lead to falls and

Who is the study for?

This trial is for US Veterans with Parkinson's Disease who experience gait disturbances, which can lead to falls and decreased independence. The goal is to help them improve their walking and balance through a non-drug treatment that they can use at home.

What is being tested?

The intervention being tested is a non-invasive cervical vagal nerve stimulation (ncVNS) device. This pilot clinical trial aims to see if using this device at home can help improve gait and balance in veterans with Parkinson's Disease.

What are the potential side effects?

Potential side effects of ncVNS are not detailed here, but similar treatments may cause mild discomfort or skin irritation where the device is used. More specific side effects will be monitored during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I experience sudden stops when I walk.

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I have been diagnosed with Parkinson's disease by a VA neurologist.

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I can walk for 2 minutes without help from devices.

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My Parkinson's disease is at a moderate stage.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to make my own health care decisions.

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I have not had spine or leg surgery in the last year.

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I have severe carotid artery disease.

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I am taking medication for nerve-related symptoms or memory issues.

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I have a condition affecting my walking and balance.

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I have severe heart disease related to artery blockage.

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I have been diagnosed with congestive heart failure.

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I have severe heart artery disease or had a heart attack before.

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I have not had fainting spells or seizures in the last 2 years.

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I have had surgery to cut the vagus nerve in my stomach.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Stride Length

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Group 2Experimental Treatment1 Intervention

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.

Group II: Group 1Experimental Treatment1 Intervention

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

Group III: Group 3Active Control1 Intervention

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

0 / 14Eligibility criteria met