Could zapping the ear unlock Gut-Brain secrets in Parkinson's?
NCT ID NCT07673146
First seen Jun 29, 2026 · Last updated Jul 02, 2026 · Updated 2 times
Summary
This study investigates how stimulating the vagus nerve through the ear affects stomach function and brain activity in people with Parkinson's disease. Participants receive non-invasive electrical stimulation via a device placed on the ear, and researchers measure stomach responses with MRI and brain activity with fMRI. The goal is to better understand gut-brain communication in Parkinson's, which may lead to new insights into the disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- UROstim (non-invasive ear stimulation device)
- What this could lead to
- If successful, this could reveal how gut-brain signals influence Parkinson's symptoms, potentially pointing toward new non-drug therapies.
- What could go wrong
- This is an early exploratory study with only 45 participants, so results may not apply broadly. The stimulation is temporary and not intended as a treatment.
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
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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
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About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2031
An estimate. End dates often move.
- Lead sponsor
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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
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21 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide 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: * Aged ≥21 years old and ≤80 years old * Clinical diagnosis of PD as defined by Movement Disorder Society (MDS) PD Criteria * Adequate visual, hearing, cognitive, and physical ability Exclusion Criteria: * Diagnosis of secondary or atypical parkinsonism * Laboratory Values: a: Hemoglobin (Hgb) \<10; b: Platelets \<70,000; c: Alanine Transaminase (ALT) or Aspartate Aminotransferase (AST) \> 2 1/2 times upper limit of normal (ULN); d: Moderate or severe renal disease with an estimated glomerular filtration rate (eGFR) \<60 mL/min/BSA \[body surface area\] calculated using the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) equation, or moderate or severe hepatic impairment (alkaline phosphatase \[ALP\] \>2.0 times the ULN and/or total bilirubin \>2.0 times the ULN); e: Significantly above the normal range for PT/INR/PTT. * Clinically significant cognitive impairment with a Montreal Cognitive Assessment (MOCA) score 35 kg/m2 or body weight * Clinical or laboratory findings consistent with another primary neurodegenerative disease or cognitive disorder other than PD, including but not limited to, frontotemporal lobar disease, Huntington's disease, progressive supranuclear palsy, multisystem atrophy, Creutzfeld-Jakob- Disease, Down's syndrome, cortico-basal degeneration, dementia with Lewy Bodies, Alzheimer's disease, amyotrophic lateral sclerosis, seizure disorder, stroke, or other infectious, metabolic, or systemic disease affecting the central nervous system including, but not limited to, syphilis, present hypothyroidism, present or unaddressed/treated vitamin B12 deficiency, or other screening laboratory abnormalities * Suicidality, defined as active suicidal thoughts or ideation within 6 months before Screening or at Baseline, defined as answering yes to items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS), or history of suicide attempt in previous 2 years, or, in the Investigator's opinion, at serious risk of suicide * Has cancer or has had a malignant tumor within the past 5 years. (Participants with stable untreated prostate cancer or treated cutaneous squamous or basal cell carcinomas are not excluded.) * Any medical condition or systemic disease that, in the Investigator's opinion, may either put the participant at risk because of participation in the study, influence the results or proposed analyses, or impair the participant's ability to fully participate in the study * Body weight \> 400lbs (limit of the MRI table) * Participant is currently pregnant, breastfeeding, and/or lactating * History of alcohol or substance abuse or dependence within the past 2 years (DSM IV criteria) * History of Covid-19 (SARS-CoV-2) infection within 6 weeks prior to screening. * Participants with unresolved symptoms of Covid-19 infection or ongoing cognitive or other deficits attributable to post-Covid-19 that may affect participant safety or interfere with cognitive assessments based on the Investigator's clinical judgment * Either ongoing or current participation in another clinical trial with an investigational agent and have taken at least one dose of study medication, unless unblinded on placebo, within 4 weeks prior to the start of screening, or five half-lives of the investigational drug, whichever is greater. The end of a previous investigational trial is the date the last dose of an investigational agent was taken. Participation in other research studies (e.g., observational studies) may be acceptable throughout this study. * History of GI surgery. (However, patients with appendicectomy, hemorrhoid surgery, and cholecystectomy will be eligible to participate). * Use of medications that impact the microbiota including antibiotics during the 4 weeks prior to enrollment * Regular use of medication that impacts the intestinal barrier (e.g., NSAID more than 3 times weekly) * Endorses any contraindications to MRI (see risks section of protocol for full list of MRI exclusions) * Allergic to pineapple
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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