Probing Gut-Brain Communication in Parkinson's Disease

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-80
SponsorSpaulding Rehabilitation Hospital

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

Qualifiers

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

Treatments tested in this trial

  • taVNS
  • Sham taVNS

Treatment groups

45 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Spaulding Rehabilitation Hospital

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator