Recruiting

Observational Study

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT06161636

Conditions

Parkinson Disease

Healthy

Parkinsonian Syndromes

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

Study Details

Brief summary:

The working hypotheses are as follows: #1 The processing of performance signals by automated lognormal segmentation and the extraction of the parameters of interest will make it possible to distinguish groups of patients from healthy elderly subjects. #2 The three instrumental approaches will not have the same degree of reliability as a predictive biomarker of clinical diagnosis established by consensus.

Conditions

Parkinson Disease

Healthy

Parkinsonian Syndromes

Study ID

NCT06161636

Start date

Feb 19, 2020

Status verified date

Feb, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Being diagnosed with Parkinsonism including idiopathic Parkinson's disease or a related syndrome;
  • Have motor symptoms of Parkinsonism for 6 years or less;
  • Be a healthy volunteer subject in good general health with no prior neurological history;
  • Age between 50-75 years old;
  • If applicable, be able to safely leave home in the morning without having taken antiparkinsonian medication for the past 12 hours.

Exclusion Criteria:

  • Major neurocognitive disorders;
  • History of other neurological conditions, such as ischemic or hemorrhagic stroke, paralysis of a limb, traumatic brain injury, epilepsy, orofacial dystonia, essential tremor;
  • History of oromandibular or laryngeal procedures;
  • Uncorrected deafness;
  • Any contraindication to pupillary dilation.

Study Design

Enrollment

90 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients with Parkinson Disease (PD)

Participants will then have to perform three blocks of tests: the first focused on the scripted motor signature, a second on the voice signature, and a complementary block aimed at capturing the motor signature using gestures of greater amplitude.

All the tests were designed to allow the characterization of the motor signature according to different aspects of motor control, but also to reproduce the same concepts in the three fields (scripted signature, voice signature and large amplitude motor signature), while allowing an acquisition of an approximate total duration of 30 minutes.

For retinal photos, the subject's pupils will be dilated using eye drops (1% tropicamide and 2.5% phenylephrine) 15-20 minutes before taking the measurement. These drugs are considered the standard used by optometrists and ophthalmologists during pupil dilation.

Patients with atypical Parkinsonian Syndromes (PS)

Participants will then have to perform three blocks of tests: the first focused on the scripted motor signature, a second on the voice signature, and a complementary block aimed at capturing the motor signature using gestures of greater amplitude.

All the tests were designed to allow the characterization of the motor signature according to different aspects of motor control, but also to reproduce the same concepts in the three fields (scripted signature, voice signature and large amplitude motor signature), while allowing an acquisition of an approximate total duration of 30 minutes.

For retinal photos, the subject's pupils will be dilated using eye drops (1% tropicamide and 2.5% phenylephrine) 15-20 minutes before taking the measurement. These drugs are considered the standard used by optometrists and ophthalmologists during pupil dilation.

Healthy volunteers

Participants will then have to perform three blocks of tests: the first focused on the scripted motor signature, a second on the voice signature, and a complementary block aimed at capturing the motor signature using gestures of greater amplitude.

All the tests were designed to allow the characterization of the motor signature according to different aspects of motor control, but also to reproduce the same concepts in the three fields (scripted signature, voice signature and large amplitude motor signature), while allowing an acquisition of an approximate total duration of 30 minutes.

For retinal photos, the subject's pupils will be dilated using eye drops (1% tropicamide and 2.5% phenylephrine) 15-20 minutes before taking the measurement. These drugs are considered the standard used by optometrists and ophthalmologists during pupil dilation.

Primary outcome measure

  • Lognormal primitives [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Pierre Blanchet, MD

514-890-8123pierre.j.blanchet@umontreal.ca

Locations

CHUM/Université de Montréal

Recruiting

Montréal, Quebec, Canada, H2X 0A9

Contacts

Pierre Blanchet, MD

514-890-8000pierre.j.blanchet@umontreal.ca

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Feb 14, 2025

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2025-02-14.