Mid-frontal Delta/Theta and Cognitive Control
Launched by NANDAKUMAR NARAYANAN · May 19, 2025
Trial Information
Current as of July 28, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
Up to 80% of patients with Parkinson's disease (PD) will suffer from cognitive symptoms, including impaired attention, planning, reasoning, and working memory as well as hallucinations, visuospatial dysfunction, and delusions. These impairments lead to mild cognitive impairment (PD-MCI) and dementia (PDD) in PD. Cognitive symptoms of PD are associated with enormous costs to society. There are no clear biomarkers and few effective treatments for PD-MCI/PDD. Because risk for PD increases dramatically with age, this problem will surge as the population grows older. The mechanisms contributing ...
Gender
ALL
Eligibility criteria
- • We will study individuals with idiopathic mild-moderate Parkinson's Disease. Diagnosis will be confirmed by Dr. Narayanan - a neurologist.
- Inclusion criteria:
- • GROUP 1: Parkinson's disease without cognitive impairment
- • 1. Parkinson's disease, with MOCA \> 26
- • 2. under stable PD medication
- • 3. able to walk independently, make their own decisions
- • 4. age range = 18 - 89 years old
- • GROUP 2: Parkinson's disease with mild cognitive impairment
- • 1. Parkinson's disease, with MOCA 23-26
- • 2. under stable PD medication
- • 3. able to walk independently, make their own decisions
- • 4. age range = 18 - 89 years old
- • GROUP 3: Parkinson's disease with dementia
- • 1. Parkinson's disease, with MOCA \< 23
- • 2. under stable PD medication
- • 3. Make their own decisions
- • 4. age range = 18 - 89 years old
- • GROUP 4: Parkinson's disease with STN-DBS 1) Parkinson's disease with functioning bilateral STN-DBS electrodes 2) under stable PD medication 3) able to walk independently, make their own decisions 4) age range = 18 - 89 years old 5) THIS GROUP WILL NOT UNDERGO TMS
- • GROUP 5: Parkinson's disease without DBS and with no seizure history for EEG-TMS study
- • 1. Parkinson's disease with MOCA 23-30
- • 2. under stable PD medication
- • 3. able to walk independently, make their own decisions
- • 4. age range = 18 - 89 years old
- • GROUP 6: Essential tremor with VIM-DBS
- • 1) Essential tremor with functioning bilateral VIM-DBS electrodes 2) able to walk independently, make their own decisions 3) age range = 18 - 89 years old 4) THIS GROUP WILL NOT UNDERGO TMS
- • GROUP 7: Parkinson's disease without DBS and with no seizure history for EEG-HD-tACS study 1) Parkinson's disease with MOCA 23-30 2) under stable PD medication 3) able to walk independently, make their own decisions 4) age range = 18 - 89 years old
- Exclusion criteria:
- • Patients with dementia with Lewy Bodies and Alzheimer's disease, drug-induced parkinsonism, Parkinson's-plus, on investigational drugs, with hearing loss will be excluded, or with color-blindness will be excluded. Subjects with a history of neuropsychiatric disorders, like Schizophrenia or Depression will be also be excluded.
- • For the TMS sub-study, PD patients with DBS leads will be excluded and any subject with a seizure disorder will also be excluded. For the HD-tACS sub-study, PD patients with DBS leads will be excluded and any subject with a seizure disorder will also be excluded.
- • Control Group: patients with Alzheimer's Disease (AD) and dementia with Lewy Bodies (DLB) A group of patients with AD and DLB will be recruited for the cognitive tasks to compare data with PD. Since AD is non-dopamine deficiency disease so they can serve as another control group for the study.
- Inclusion criteria:
- • 1) age range = 18 - 89 years old (will have to match with the age of subjects with Parkinson's Disease)
- Exclusion criteria:
- • 1) with any neurological disorders, including epilepsy
- • Control Group: patients with mTBI A group of patients with mTBI will be recruited for the cognitive tasks to compare data with PD.
- Inclusion criteria:
- • 1) age range = 18 - 89 years old (will have to match with the age of subjects with Parkinson's Disease)
- Exclusion criteria:
- • Control Group: patients with 16pDel Autism A group of patients with 16pDel Autism will be recruited for the cognitive tasks to compare data with PD.
- Inclusion criteria:
- • 1) age range = 18 - 89 years old (will have to match with the age of subjects with Parkinson's Disease)
- Exclusion criteria:
- • Control Group: patients with Brain Lesions A group of patients with Brain Lesions will be recruited for the cognitive tasks to compare data with PD.
- Inclusion criteria:
- • 1) age range = 18 - 89 years old (will have to match with the age of subjects with Parkinson's Disease)
- Exclusion criteria:
- • Control Group: Older Normal Subjects A group of older healthy individuals will be matched with subjects with Parkinson's disease in terms of age, sex, and years of education. We will also recruit a small group of older healthy individuals specifically to pilot new behavioral tasks.
- Inclusion criteria:
- • 1) age range = 35 - 99 years old (most of this group will have to match with the age of subjects with Parkinson's Disease. One subset from this group (N = 40) will be independent from the demographics of the subjects with Parkinson's Disease, so they can have a wider age range).
- Exclusion criteria:
- • 1) with any neurological disorders, including epilepsy
- • Control Group: Older Subjects with Mood Disorders A group of older individuals with Mood Disorders will be recruited to perform cognitive tasks to compare data with both PD with Mood Disorders and PD without Mood Disorders.
- Inclusion criteria:
- • 1) age range = 18 - 89 years old (will have to match with the age of subjects with Parkinson's Disease)
- Exclusion criteria:
- • 1) with any neurological disorders, including epilepsy
- • Control group: Healthy young and middle-aged adults
- • A group of healthy young and middle-aged adults without Parkinson's disease or other neurological issues.
- • 1) age range = 18-60 years old
- • Exclusion criteria: 1) any neurological disorders, including epilepsy
- • Control subjects' mothers
- • - The group of mothers of the healthy young adult control subjects.
About Nandakumar Narayanan
Nandakumar Narayanan is a dedicated clinical trial sponsor with extensive expertise in advancing innovative medical research and development. With a focus on enhancing patient outcomes, he leads initiatives that aim to evaluate new therapies and interventions across various therapeutic areas. Nandakumar is committed to adhering to the highest standards of ethical conduct and regulatory compliance, ensuring the integrity and reliability of clinical data. His collaborative approach fosters strong partnerships with research institutions and healthcare professionals, driving the successful execution of clinical trials that contribute to the advancement of medical science.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Iowa City, Iowa, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported