Detection of Internal Tremors by Oscillometry in Parkinson's Patient (TREMOS-PD)

Toulouse University Hospital

Status: Not yet enrolling

Conditions: Parkinson Disease

Treatments: Diagnostic Test: Detection of objective internal tremors

Study type: Interventional

Funder types: Other

Identifiers

NCT06885541

RC31/25/0028

2025-A00133-46 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Parkinson's disease patients

Other group

Description:

Parkinson's disease patient in the off phase.

Treatment:

Diagnostic Test: Detection of objective internal tremors

Healthy participants

Other group

Description:

Healthy participants

Treatment:

Diagnostic Test: Detection of objective internal tremors