Clinical trial NCT06885541: Detection of Internal Tremors by Oscillometry in Parkinson's Patient
Official title: Detection of Internal Tremors by Oscillometry in Parkinson's Patient : a Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson
Internal tremor
Tremor
Wearable devices
Accelerometer
Parkinson&#39;s disease
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: Fondation de l'Avenir
First posted: 2025-03-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups of participants : the first group consists of Parkinson's disease patients in the off phase, while the second group consists of healthy participants.
Primary purpose: DIAGNOSTIC

Brief summary: The goal of the present study is to objectively access the presence of an Internal Tremor in Parkinson's disease. Inertial sensors will be used to detect the presence of a rhythmic oscillation of 3-4 Hz. The study will be performed in both Parkinson's disease patients and healthy controls to ascertain the specificity of this type of tremor.

Detailed description: The interest in finding prodromal symptoms in Parkinson's disease has been growing. Internal tremor, felt subjectively by the patients, have been reported in some studies as being present on the Prodromal phases of the disease. An objective identification of this tremor has never been made. In this study we propose to objectively access the presence of Internal Tremor in Parkinson's Disease patients using accelerometers. A control population of healthy subjects will also be evaluated to confirm the specificity of tremor for a PD population.

Eligibility criteria: Inclusion Criteria:

(For the experimental group)

* Patient with idiopathic parkinson's disease
* Mini Mental State Evaluation score above or equal to 25
* Hoehn and Yahr scale score of ≤3 in the OFF phase, with postural stability allowing the patient to stand unaided for 1 minute.
* Able to walk unassisted
* No major osteoarticular issues
* Presence of another neurological condition that may affect gait
* Willing to undergo accelerometry in the OFF state

(For the control group)

* Healthy volunteer subjects matched for age (+/- 5 years) and sex
* Mini Mental State Evaluation score above or equal to 25

Exclusion Criteria:

(For the experimental group)

* Patients with an atypical parkinsonian syndrome
* Patients unable to walk or stand for more than one minute in the off state
* Parkinson's patients treated with deep brain stimulation, apomorphine pump, or duodopa intestinal infusion, and foslevodopa
* Pregnant patients

(For the control group)

* Participants with significant gait impairment (osteoarticular disorder)
* Those with a neurological disease that, in the investigator's judgment, may interfere with the study's outcome measure
* Participants with a clinical tremor that may interfere with the measurement of the primary outcome (e.g., essential tremor, thyroid disease, or tremors induced by medication)
* Pregnant participants

Primary outcomes:
measure: Difference in intensity of the peak power at 4-6 Hz
timeFrame: Baseline
Secondary outcomes:
measure: Association between subjective internal tremors and frequency peak between 4 and 6 Hz
timeFrame: Baseline
measure: Association between Objective Internal Tremor and Motor Symptom Severity in Parkinson's Disease as Assessed by the MDS-UPDRS
timeFrame: Baseline
measure: Evaluation of Objective Internal Tremor Powers Detected by Different Sensors in Parkinson's Disease
timeFrame: Baseline
measure: Evaluation of Acceptability of Motion Sensor Examination Using the Visual Analog Scale
timeFrame: Baseline
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Purpan Hospital
state: Occitanie
Study officials:
References:
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