Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-24 @ 7:09 PM
NCT ID:
NCT06984757
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT06984757
Study Brief:
Protocol Section:
NCT06984757