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Can a breathing and Nerve-Zapping combo help clear the Parkinson's brain?

NCT ID NCT07814534

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers are testing whether a week-long program of guided breathing, brief exposure to a low-concentration carbon dioxide gas mixture, and noninvasive vagus nerve stimulation can be done safely and comfortably in adults with early-stage Parkinson's disease and healthy older adults. The pilot study enrolls 20 participants who complete two intervention visits, one with active nerve stimulation and one with sham stimulation, while researchers monitor breathing, heart function, brain activity, and fluid movement around the brain. The goal is to see whether the procedures are feasible and how they affect physiological signals, not to treat or prevent Parkinson's disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
noninvasive vagus nerve stimulation using the gammaCore device, paired with guided breathing and brief exposure to a 5% carbon dioxide gas mixture
What this could lead to
If the approach proves safe and tolerable, it could guide larger studies into whether these combined procedures influence brain fluid flow and autonomic function in Parkinson's disease.
What could go wrong
This is a small, early-stage pilot with 20 participants. It is not designed to treat or prevent Parkinson's disease, and any physiological changes may be temporary or unrelated to the disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria Parkinson's Disease Group Adults aged 60-80 years at the time of enrollment. Clinical diagnosis of early-stage Parkinson's disease and not currently receiving levodopa or other dopaminergic medication. Hoehn and Yahr stage I. English-speaking and able to provide informed consent and complete study procedures and questionnaires administered in English. Cognitively able to participate in study procedures, as determined by investigator assessment and/or optional cognitive screening measures, when administered. Willing and able to comply with all study visits and procedures. Able to tolerate wearing the Applied Cognition GF Monitor, physiological monitoring equipment, face mask, and noninvasive vagus nerve stimulation (nVNS) device for the duration of study procedures. Age-Matched Healthy Control Group Adults aged 60-80 years at the time of enrollment. No known diagnosis of Parkinson's disease or other major neurodegenerative disorder. English-speaking and able to provide informed consent and complete study procedures and questionnaires administered in English. Cognitively able to participate in study procedures, as determined by investigator assessment and/or optional cognitive screening measures, when administered. Willing and able to comply with all study visits and procedures. Able to tolerate wearing the Applied Cognition GF Monitor, physiological monitoring equipment, face mask, and noninvasive vagus nerve stimulation (nVNS) device for the duration of study procedures. Exclusion Criteria Diagnosis of moderate-to-severe neurocognitive impairment or dementia. Significant pulmonary disease, including chronic obstructive pulmonary disease (COPD), severe asthma requiring daily rescue therapy, restrictive lung disease, or resting oxygen saturation \<92%. Untreated or poorly controlled hypertension, defined as systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mmHg at screening. Symptomatic hypotension, orthostatic hypotension associated with syncope, or clinically significant autonomic dysfunction. Peripheral vascular disease, significant upper-extremity injury, or other conditions that may interfere with peripheral perfusion or physiological monitoring measurements. Uncontrolled diabetes mellitus or diabetes-associated complications that may significantly affect autonomic or vascular physiology. History of significant cardiac disease, including clinically significant arrhythmia, congestive heart failure, unstable angina, myocardial infarction within the prior 12 months, or other conditions judged unsafe for intermittent hypercapnia exposure. Active implanted electrical or neurostimulation devices, including cardiac pacemakers, implantable cardioverter-defibrillators (ICDs), deep brain stimulators, cochlear implants, or implanted vagus nerve stimulators. Active carotid artery disease, carotid bruits, history of carotid endarterectomy, or other clinically significant cervical vascular abnormalities that may increase risk during cervical nVNS application. History of moderate or severe traumatic brain injury, defined as loss of consciousness \>30 minutes or post-traumatic amnesia \>24 hours. Active psychiatric condition requiring hospitalization within the prior 12 months. Current use of medications known to substantially alter cerebrovascular reactivity or carbon dioxide sensitivity, such as acetazolamide or other carbonic anhydrase inhibitors. Claustrophobia or inability to tolerate mask-based breathing procedures. Pregnancy, suspected pregnancy, or lactation in participants of childbearing potential. Body mass index (BMI) \>40 kg/m² due to potential effects on respiratory physiology, mask fit, and CO₂ tolerance. Known allergy or sensitivity to latex, adhesives, electrode gels, medical tapes, or study device materials that may interfere with safe participation. Current acute respiratory infection or other acute illness at the time of study participation. Any other medical, neurological, psychiatric, or safety-related condition that, in the opinion of the Principal Investigator, would compromise participant safety, interfere with study procedures, or affect data integrity.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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