Recruiting

Observational Study

Sponsor:

Jacob E. Simmering

Code:

NCT06573762

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Parkinson Disease

Study ID

NCT06573762

Start date

Apr 7, 2025

Status verified date

Apr, 2025

Completion date

Jan 1, 2028

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Group 1: People newly referred with possible Parkinson's disease

Inclusion Criteria

1. Newly referred to UIHC Movement Disorders Clinic

Exclusion Criteria

1. Prior diagnosis of Parkinson's disease
2. Confined to wheelchair or bed
3. Non-English speaking
4. Prisoner status
5. Inability to provide own informed consent
6. Phone unable to support the Fitbit app

Group 2: People with a recent diagnosis of Parkinson's disease

Inclusion Criteria

1. Patient of UIHC Movement Disorders Clinic
2. Diagnosed with Parkinson's disease

Exclusion Criteria

1. First diagnosed > 6 months ago
2. Confined to wheelchair or bed
3. Non-English speaking
4. Prisoner status
5. Inability to provide own informed consent
6. Phone unable to support the Fitbit app

Study Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

Recently Referred for Possible Parkinson's Disease

Patients referred to the University of Iowa Hospitals and Clinics (UIHC) Movement Disorders Clinic for possible Parkinson's disease.

Recently Diagnosed with Parkinson's Disease

Patients of the UIHC Movement Disorders Clinic with a recent (less than 6 months) diagnosis of Parkinson's disease.

Primary outcome measure

  • Number of Patients with a Diagnosis of Parkinson's Disease [ Time Frame: Baseline ]
  • Change in Fine Motor Function [ Time Frame: Baseline, One Year ]
  • Change in Total Cognition Composite Function [ Time Frame: Baseline, One Year ]
  • Change in Total Crystallized Cognition Function [ Time Frame: Baseline, One Year ]
  • Change in Total Fluid Cognition Function [ Time Frame: Baseline, One Year ]
  • Change in Montreal Cognitive Assessment Scores [ Time Frame: Baseline, One Year ]

Central Contacts and Locations

Central contacts

Jacob Simmering, MS, PHD, BA

3196788037jacob-simmering@uiowa.edu

Shelby Francis, PhD

shelby-francis@uiowa.edu

Locations

University of Iowa Hospitals and Clinics

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Jacob Simmering, PhD

3196788037jacob-simmering@uiowa.edu

More Information

Sponsor

Jacob E. Simmering

Last update posted

Apr 10, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Jacob E. Simmering on 2025-04-10.