Parkinson Disease (PD)
Conditions
Brief summary
Administering transcutaneous vagus nerve stimulation in patients with Parkinson's disease to see how it affects stomach and brain activity.
Interventions
DEVICEtaVNS
Active taVNS delivered to the external ear at a moderate, non-painful level.
DEVICESham taVNS
Sham taVNS delivered to the external ear using zero-current.
Sponsors
Spaulding Rehabilitation Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastric outcomes (accommodation and emptying) during UROstim administration as measured by gastric MRI | 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 | 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. |
Contacts
CONTACTNoah Naddaff-Slocum, BA
Outcome results
None listed