Recruiting

Observational Study

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT04231487

Conditions

Essential Tremor

Parkinson Disease

Huntington Disease

Dystonia, Primary

Spinocerebellar Ataxias

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The purpose of the research is to better understand the motor behavior of individuals in health and disease. The specific purpose of this project is to identify if we can utilize a smartphone to diagnose different movement disorders and monitor their symptoms.

A. Objectives

1. Estimate symptom severity of Essential tremor (ET), Parkinson's disease (PD), Huntington's disease (HD), Primary focal dystonia (PFD), spinocerebellar ataxia (SCA), and Functional movement disorders (FMD) using a smartphone-based application
2. Differentiate individuals with the different movement disorders from healthy controls based on features from the smartphone data
3. Differentiate individuals with a specific movement disorder from people with other movement disorders based on features from the smartphone data

B. Hypotheses / Research Question(s) We hypothesize that we can estimate the severity of symptoms using a smartphone application and that, using those estimates, we can differentiate individuals with movement disorders from healthy controls and from people with other movement disorders.

Conditions

Essential Tremor

Parkinson Disease

Huntington Disease

Dystonia, Primary

Spinocerebellar Ataxias

Study ID

NCT04231487

Start date

Jun 27, 2019

Status verified date

Sep, 2022

Completion date

Dec 31, 2022

Anticipated

Primary completion date

Dec 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male and female
  • At least 18 years of age
  • Ambulatory
  • English speaking
  • Specific to group 1: a) Diagnosis of ET, b) stable dose of medication for 30 days
  • Specific to group 3: a) Diagnosis of PD, b) stable dose of medication for 30 days
  • Specific to group 4: a) Diagnosis of HD, b) stable dose of medication for 30 days
  • Specific to group 5: a) Diagnosis of PFD, b) stable dose of medication for 30 days
  • Specific to group 6: a) Diagnosis of SCA, b) stable dose of medication for 30 days
  • Specific to group 7: a) Diagnosis of FMD, b) stable dose of medication for 30 days

Exclusion Criteria:

  • Serious untreated psychiatric illness that could impact the data collection
  • Inability to understand task or protocol due to cognitive problems
  • Other neurological condition that could affect the performance of motor tasks
  • Musculoskeletal condition that could affect the performance of motor tasks
  • Uncorrected vision impairment
  • Specific to groups 1, 3, 4, 5, 6, and 7: Expected change in medication within the next 8 weeks

Study Design

Enrollment

210 participants

Anticipated

Interventions and Outcome Measures

Arms

Essential tremor

This is not an intervention study.

Specific to group: a) Diagnosis of ET, b) stable dose of medication for 30 days

Parkinson's Disease

This is not an intervention study.

Specific to group: a) Diagnosis of PD, b) stable dose of medication for 30 days

Huntington's Disease

This is not an intervention study.

Specific to group: a) Diagnosis of HD, b) stable dose of medication for 30 days

Primary Focal Dystonia

This is not an intervention study.

Specific to group: a) Diagnosis of PFD, b) stable dose of medication for 30 days

Spinocerebellar Ataxia

This is not an intervention study. Specific to group: a) Diagnosis of SCA, b) stable dose of medication for 30 days

Functional Movement Disorder

This is not an intervention study. Specific to group: a) Diagnosis of FMD, b) stable dose of medication for 30 days

Healthy Controls

This is not an intervention study.

People with Healthy Controls

Primary outcome measure

  • UPDRS-III (Unified Parkinson's Disease Rating Scale) [ Time Frame: Will occur right after the consent received from patients during the first lab visit. ]
  • TETRAS-performance (The Essential Tremor Rating Assessment Scale) [ Time Frame: Will occur right after the consent received from patients during the first lab visit. ]
  • Motor UHDRS for HD (Unified Huntington's Disease Rating Scale: Reliability and Consistency) [ Time Frame: Will occur right after the consent received from patients during the first lab visit. ]
  • (UDRS) Unified Dystonia Rating Scale [ Time Frame: Will occur right after the consent received from patients during the first lab visit. ]
  • (BARS) Brief Ataxia Rating Scale [ Time Frame: Will occur right after the consent received from patients during the first lab visit. ]
  • (s-FMDRS) Simplified Functional Movement Disorders Rating Scale [ Time Frame: Will occur right after the consent received from patients during the first lab visit. ]

Central Contacts and Locations

Central contacts

Jean-François Daneault, PHd

973-972-8482jf.daneault@rutgers.edu

Locations

Rutgers University

Recruiting

Newark, New Jersey, United States, 07107

Contacts

Jean-François Daneault, PhD

973-972-8482jf.daneault@rutgers.edu

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Sep 21, 2022

Last verified

Sep, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2022-09-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.