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

This trial does not accept healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • taVNS

    Device

    Active taVNS delivered to the external ear at a moderate, non-painful level.

  • Sham taVNS

    Device

    Sham taVNS delivered to the external ear using zero-current.

Treatment groups

45 Participants
are divided into 2 treatment groups
Group A: taVNSExperimental treatment 1 intervention
Group B: Sham taVNSSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment until the completion of their final visit, which will not exceed a duration of 4 weeks.
2

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.

Time frame
From enrollment to the end of their study participation, typically 4 weeks.

Secondary outcomes

Other outcomes

Locations

This trial has no 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: