Status:
ENROLLING_BY_INVITATION
Mid-frontal Delta/Theta and Cognitive Control
Lead Sponsor:
Nandakumar Narayanan
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Parkinson&Amp;Amp;#39;s Disease (PD)
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
Abstract Cognitive symptoms of Parkinson's disease (PD) include deficits in attention, working memory, and reasoning. These deficits affect up to 80% of PD patients and lead to mild cognitive impairme...
Detailed Description
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 d...
Eligibility Criteria
Inclusion
- 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
- Parkinson's disease, with MOCA \> 26
- under stable PD medication
- able to walk independently, make their own decisions
- age range = 18 - 89 years old
- GROUP 2: Parkinson's disease with mild cognitive impairment
- Parkinson's disease, with MOCA 23-26
- under stable PD medication
- able to walk independently, make their own decisions
- age range = 18 - 89 years old
- GROUP 3: Parkinson's disease with dementia
- Parkinson's disease, with MOCA \< 23
- under stable PD medication
- Make their own decisions
- 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
- Parkinson's disease with MOCA 23-30
- under stable PD medication
- able to walk independently, make their own decisions
- 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.
Exclusion
Key Trial Info
Start Date :
September 25 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
635 Patients enrolled
Trial Details
Trial ID
NCT06984757
Start Date
September 25 2017
End Date
December 31 2029
Last Update
May 22 2025
Active Locations (1)
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1
University of Iowa
Iowa City, Iowa, United States, 52242