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Superior Parietal iTBS for PD-MCI

Accelerated Intermittent Theta Burst Stimulation for Mild Cognitive Impairment in Parkinson's Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a short-term, high-dose brain stimulation treatment called iTBS that does not require surgery. It aims to learn if the treatment is safe and promising for people with Parkinson’s disease who have mild problems with memory or thinking.

The goal of this study is to determine the whether a short-term, high-dose form of non-invasive brain stimulation (intermittent theta burst stimulation; iTBS) is a promising and safe treatment for mild cognitive impairment in Parkinson's disease (PD-MCI).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 50 to 85 years old.
  • You have Parkinson’s disease diagnosed using the study’s required standards.
  • A specialist has confirmed mild memory or thinking problems using the study’s required standards and tests.
  • Your Parkinson’s medicines have been stable for 30 days and are not expected to change during treatment.
  • You have a caregiver who is willing and able to reliably fill out a form about your daily activities.

Who can't join

  • You fear tight spaces or cannot lie on your back in a scanner for a long time.
  • Something prevents the brain stimulation coil from touching your skin, such as braids that cannot be removed.
  • You have a safety risk for MRI scans or magnetic brain stimulation, such as an implanted medical device, metal in your body, hair clips or piercings that cannot be removed, or medicines that raise seizure risk.
  • You have bipolar disorder, schizophrenia, or a current substance abuse disorder.
  • You have a history of a serious or unstable illness, or treatment, that study doctors think may affect your thinking. Examples include heart failure, infections, poorly controlled diabetes, cancer, developmental disorders, or other brain or nerve diseases.
  • You have a history of a seizure disorder.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 50-85 years of age * Diagnosis of Parkinson's disease based on UK Brain Bank diagnostic criteria * Parkinson's disease with mild cognitive impairment (PD-MCI) diagnosis per Movement Disorders Society Task Force Level II Diagnostic Criteria4 (i.e., scores ≥1.5 standard deviations below appropriate norms on 2 neuropsychological tests) as determined by a clinical neuropsychologist * Stable on Parkinson's disease medications for 30 days (not expected to change through the course of the treatment) * Has a caregiver willing and able to reliably complete a questionnaire focused on the participant's daily functioning Exclusion Criteria: * Claustrophobia or inability to lie supine in the scanner for an extended period of time * Barriers to making contact between the TMS coil and the skin (e.g. braids that cannot be removed) * Contraindications to MRI/TMS safety screening: This includes but is not limited to implanted medical devices (e.g., pacemakers), metallic objects or fragments, non-removable hair clips or piercings, and medications that reduce seizure threshold. * Individuals with a diagnosis of bipolar disorder, schizophrenia, and/or active substance abuse disorder. * History of significant or unstable condition/s or treatments for these condition/s that may impact cognition (as determined by the study investigators) such as significant cardiac (e.g. heart failure), infectious (e.g. HIV, urinary tract infection), or metabolic disease (e.g. labile diabetes), cancer (e.g. brain cancer, chemotherapy-induced cognitive impairment), developmental disorder (e.g. autism spectrum disorder, intellectual disability), or other neurologic disease (e.g. multiple sclerosis, moderate to severe brain injury, seizures). * History of a seizure disorder.

Study sites (1)

SC