NCT06573762 · Jacob E. Simmering
Home-Based Monitoring in Parkinson's Disease
What this study is about
The goal of this observational study is to learn about the usefulness of automated analysis of speech, physical activity measures tracked using wearable devices at home, and tremor detection measured using computer-vision analysis of smartphone video to detect impairments related to Parkinson's disease and improve prediction of one-year progression.
View original scientific description
The goal of this observational study is to learn about the usefulness of automated analysis of speech, physical activity measures tracked using wearable devices at home, and tremor detection measured using computer-vision analysis of smartphone video to detect impairments related to Parkinson's disease and improve prediction of one-year progression. Participants will attend a short research visit at the University of Iowa. During this visit, they will make a video recording using a smartphone of them performing a fine motor task and audio recordings of pre-written text. They will be provided with an activity tracker and asked to wear it at home for four weeks. After four weeks, a video visit will be conducted and the speech and video tasks will be repeated.
Primary outcome measures
Number of Patients with a Diagnosis of Parkinson's Disease
Time frame: Baseline
Among Group 1 (those newly referred to the clinic for possible Parkinson's disease), a primary outcome will be whether the diagnosis made by the provider in the clinic was Parkinson's disease versus any other diagnosis. This is not an outcome for Group 2 (those with a recent diagnosis of Parkinson's disease) as everyone in that group will have that diagnosis.
Change in Fine Motor Function
Time frame: Baseline, One Year
Motor function will be evaluated using the UPDRS rating system.
Change in Total Cognition Composite Function
Time frame: Baseline, One Year
Total Cognition Composite will be calculated using the NIH Toolbox Cognition Battery. This score has a range from 0 to 200 with healthy adults having a mean score of 100 with a standard deviation of 15. Higher scores are associated with better cognitive performance.
Change in Total Crystallized Cognition Function
Time frame: Baseline, One Year
Crystallized Cognition Composite will be calculated using the NIH Toolbox Cognition Battery. This score has a range from 0 to 200 with healthy adults having a mean score of 100 with a standard deviation of 15. Higher scores are associated with better cognitive performance.
Change in Total Fluid Cognition Function
Time frame: Baseline, One Year
Fluid Cognition Composite will be calculated using the NIH Toolbox Cognition Battery. This score has a range from 0 to 200 with healthy adults having a mean score of 100 with a standard deviation of 15. Higher scores are associated with better cognitive performance.
Change in Montreal Cognitive Assessment Scores
Time frame: Baseline, One Year
The Montreal Cognitive Assessment (MoCA) has a range of 0-30. Higher scores are associated with better cognitive function. Scores of 26 or higher are considered cognitively normal. Scores less than 26 are suggestive of cognitive impairment, with dementia scores being below 20 but without a universally-accepted cutoff.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 1\. Newly referred to UIHC Movement Disorders Clinic
Exclusion criteria
- Prior diagnosis of Parkinson's disease
- Confined to wheelchair or bed
- Non-English speaking
- Prisoner status
- Inability to provide own informed consent
- Phone unable to support the Fitbit app Group 2: People with a recent diagnosis of Parkinson's disease Inclusion Criteria
- Patient of UIHC Movement Disorders Clinic
- Diagnosed with Parkinson's disease Exclusion Criteria
- First diagnosed \> 6 months ago
- Confined to wheelchair or bed
- Non-English speaking
- Prisoner status
- Inability to provide own informed consent
- Phone unable to support the Fitbit app
Where
- Iowa City, Iowa
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 10, 2025 · Source of record for eligibility and locations