Parkinson Disease (PD)NCT07673146
Probing Gut-Brain Communication in Parkinson's Disease
A study testing taVNS in people with Parkinson Disease (PD), run by Spaulding Rehabilitation Hospital.
Trial summary
Administering transcutaneous vagus nerve stimulation in patients with Parkinson's disease to see how it affects stomach and brain activity. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Parkinson Disease (PD)
- What is being tested?
- taVNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 1 Jul 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.)
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Administering transcutaneous vagus nerve stimulation in patients with Parkinson's disease to see how it affects stomach and brain activity.
- Conditions
- Parkinson Disease (PD)
- Being tested
- taVNS, Sham taVNS
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taVNSDevice
Active taVNS delivered to the external ear at a moderate, non-painful level.
Sham taVNSDevice
Sham taVNS delivered to the external ear using zero-current.
| Study group | Role | What they receive |
|---|---|---|
| taVNS | Experimental | Active taVNS Receives: Device: taVNS |
| Sham taVNS | Sham comparator | Sham taVNS Receives: Device: Sham taVNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric outcomes (accommodation and emptying) during UROstim administration as measured by gastric MRI
The study team will be measuring and comparing how the stomach responds to food (how much it expands and how quickly it empties) when the participant has stimulation delivered right after eating vs. having sham delivered right after eating.
Measured: From enrollment until the completion of their final visit, which will not exceed a duration of 4 weeks.
Brain activity during UROstim administration as measured by fMRI
The study team will be investigating how brain activity and connectivity differs when the subject experiences vagus nerve stimulation vs. sham stimulation.
Measured: From enrollment to the end of their study participation, typically 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jul 2031 (estimated)
- Study completion1 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease (PD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberta Sclocco, Spaulding Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07673146
- Sponsor's protocol ID
- 2026P001274
- Other IDs
- U01DK140933
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probing Gut-Brain Communication in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07673146
- Acronym / sponsor ID
- 2026P001274
- Conditions
- Parkinson Disease (PD)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jul 2031 (estimated)
- Study completion
- 1 Jul 2031 (estimated)
- First posted
- 29 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Administering transcutaneous vagus nerve stimulation in patients with Parkinson's disease to see how it affects stomach and brain activity.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| taVNS | Experimental | Device: taVNSActive taVNS |
| Sham taVNS | Sham comparator | Device: Sham taVNSSham taVNS |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| taVNSActive taVNS delivered to the external ear at a moderate, non-painful level. | Device | taVNS |
| Sham taVNSSham taVNS delivered to the external ear using zero-current. | Device | Sham taVNS |
Primary outcome
Gastric outcomes (accommodation and emptying) during UROstim administration as measured by gastric MRI
Time frame: From enrollment until the completion of their final visit, which will not exceed a duration of 4 weeks.
The study team will be measuring and comparing how the stomach responds to food (how much it expands and how quickly it empties) when the participant has stimulation delivered right after eating vs. having sham delivered right after eating.
Brain activity during UROstim administration as measured by fMRI
Time frame: From enrollment to the end of their study participation, typically 4 weeks.
The study team will be investigating how brain activity and connectivity differs when the subject experiences vagus nerve stimulation vs. sham stimulation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing taVNS in people with Parkinson Disease (PD), run by Spaulding Rehabilitation Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noah Naddaff-Slocum, BA (617-724-6086, nnaddaff-slocum@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric outcomes (accommodation and emptying) during UROstim administration as measured by gastric MRI (time frame: From enrollment until the completion of their final visit, which will not exceed a duration of 4 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.