No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
50 – 85
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
Medical University of South Carolina · Other
Who this trial is looking for
This trial is looking for people aged 50 to 85 who have mild cognitive impairment due to Parkinson's disease. Participants will receive a type of brain stimulation treatment to see if it helps their condition.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 50 and 85 years old.
I have been diagnosed with Parkinson's disease.
I have mild cognitive impairment related to my Parkinson's disease.
I have been stable on my Parkinson's disease medications for the last 30 days.
I have a caregiver who can help keep track of my daily functioning.
You may not be able to join if
I have claustrophobia or cannot lie flat for a long time.
I have things in my body that could interfere with the treatment, like a pacemaker.
I have a history of conditions like bipolar disorder or schizophrenia.
I have a history of significant health issues that could affect my thinking.
I have a history of seizures.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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).
Trial Locations
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Status
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 deviatio…
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.
Contacts
No contact information available.
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