About this trial
Administering transcutaneous vagus nerve stimulation in patients with Parkinson's disease to see how it affects stomach and brain activity.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Crossover
Treatments tested in this trial
taVNS
DeviceActive taVNS delivered to the external ear at a moderate, non-painful level.
Sham taVNS
DeviceSham taVNS delivered to the external ear using zero-current.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Spaulding Rehabilitation Hospital
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
This trial is not recruiting at the moment. You can still explore other options: