Clinical study of medical devices for quantifying and/or classifying motor deficits in patients with Parkinson’s disease or essential tremor - Clinical study for ANLIVA™ Dyskinesia & ANLIVA™ Eye Movement

Patients with tremor or hyperkinesia or with ocular motor deficits such as e.g. patients with Parkinson's disease or essential tremor. Measurement/ quantification of tremor or hyperkinesia using the mobile sensors of a Smartphone or of eye movements by using an advanced tracking camera device in combination with a computer No comparator Complications/adverse events and statistics of such; Correlation and accuracy of quantification of tremor or hyperkinesia or correlation and accuracy of the eye movements.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN82413223

Enrollment

Registered

2023-12-14

Start date

2023-03-15

Completion date

Unknown

Last updated

2024-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's disease and essential tremor Nervous System Diseases

Interventions

This exploratory pilot study aims to assess mathematical algorithms' performance using smartphone sensor data and eye tracking in individuals with Parkinson’s disease and essential tremor. The study i

ii) sit down in front of a computer and look at moving dot on the computer screen and an advanced camera records the eye movements

and, iii) have an assessment of their status by health care personnel. No intervention is done, i.e. no change in any medication nor anything else that changes the medical state the subject is in. The

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients already diagnosed with PD or ET or Healthy volunteers 2. Able to understand and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. No signing of the informed consent 2. Below 18 years of age 3. Involvement in the planning and conduct of the clinical investigation (applies to all Stardots management staff, investigational staff and third-party vendors as applicable).

Design outcomes

Primary

Measure	Time frame
1. Movement disorder of hands measured using sensors in a mobile smartphone when the subject moves the mobile phone in a certain pattern, for approx. 1 minute during a visit to the clinic under supervision by healthcare personnel. This is for the ANLIVA™ Dyskinesia. 2. Movement disorder of eyes measured using an advanced camera when the subject looks at a computer screen and follows how a pattern moves on a computer screen, for approx. 2 minutes during a visit to the clinic under supervision by healthcare personnel. This is for the ANLIVA™ Eye Movement.	—

Measure

Time frame

1. Movement disorder of hands measured using sensors in a mobile smartphone when the subject moves the mobile phone in a certain pattern, for approx. 1 minute during a visit to the clinic under supervision by healthcare personnel. This is for the ANLIVA™ Dyskinesia. 2. Movement disorder of eyes measured using an advanced camera when the subject looks at a computer screen and follows how a pattern moves on a computer screen, for approx. 2 minutes during a visit to the clinic under supervision by healthcare personnel. This is for the ANLIVA™ Eye Movement.

—

Secondary

Measure	Time frame
The following secondary outcome measures are measured using data recorded during the clinic visit: 1. Correlate the result of tremor and hyperkinesia detection with a neurologist assessment 2. Accuracy of classification between ET- and PD-induced tremor or hyperkinesia 3. Receiver Operating Characteristic (ROC) curve analysis 4. Accuracy of classification 5. Receiver Operating Characteristic (ROC) curve analysis	—

Measure

Time frame

The following secondary outcome measures are measured using data recorded during the clinic visit: 1. Correlate the result of tremor and hyperkinesia detection with a neurologist assessment 2. Accuracy of classification between ET- and PD-induced tremor or hyperkinesia 3. Receiver Operating Characteristic (ROC) curve analysis 4. Accuracy of classification 5. Receiver Operating Characteristic (ROC) curve analysis

—

Countries

Sweden

Contacts

Public ContactMartin Nilsson

martin.nilsson@stardots.se+46(0)707799295

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026