An interventional study of Detection of objective internal tremors in Parkinson Disease, sponsored by University Hospital, Toulouse. Recruiting at 1 site in France. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-17.
Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Diagnostic
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.
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.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's planned enrollment of 60 is above the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
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(For the experimental group)
(For the control group)
Exclusion Criteria:
(For the experimental group)
(For the control group)
Parkinson's disease patient in the off phase.
Diagnostic Test: Detection of objective internal tremors
Healthy participants
Diagnostic Test: Detection of objective internal tremors
head-mounted motion sensors
Difference in intensity of the peak power at 4-6 Hz
Difference in maximum signal power in the 4 to 6 Hz frequency band of the objective internal tremor, recorded from the head sensor, between the group of Parkinson's patients and a matched group of healthy volunteers.
Time frame: Baseline
Association between subjective internal tremors and frequency peak between 4 and 6 Hz
The difference between objective internal tremor and subjective internal tremor is a descriptive outcome measure and will be assessed using the correlation coefficient between the score on the Internal Tremor Questionnaire, which measures subjective internal tremor intensity, and the maximum signal power in the 4 to 6 Hz frequency band of objective internal tremor. The Internal Tremor Questionnaire measures the intensity of internal tremor perceived by subjects. It consists of 13 questions. At the end of the questionnaire, the patient receives a score out of 13, with 0 being the best score and 13 being the worst score. The objective internal tremor is measured via the sensors measure the movement associated with muscle contractions. The data is recorded as a time series, which represents the tremor amplitude at discrete time intervals.
Time frame: Baseline
Association between Objective Internal Tremor and Motor Symptom Severity in Parkinson's Disease as Assessed by the MDS-UPDRS
The association between objective internal tremor and symptom severity will be a descriptive analyses and assessed using the correlation coefficient between the score on the MDS-UPDRS (Part III - Motor Symptoms), which evaluates motor symptom severity in Parkinson's patients, and the maximum signal power in the 4 to 6 Hz frequency band of objective internal tremor. The scale is a composite, with scores ranging from 0 to 120, where higher scores indicate greater symptom severity, meaning that a lower score reflects a better clinical condition. see above for how the Objective Internal tremor is assessed.
Time frame: Baseline
Evaluation of Objective Internal Tremor Powers Detected by Different Sensors in Parkinson's Disease
The powers of the objective internal tremor detected by the other sensors will be assessed by comparing the maximum signal power in the 4 to 6 Hz frequency band of each sensor (back and thigh on the most affected side of Parkinson's disease) to the head sensor.
Time frame: Baseline
Evaluation of Acceptability of Motion Sensor Examination Using the Visual Analog Scale
Acceptability will be assessed using the scores from the Visual Analog Scale (VAS), (0 = not acceptable to 10 = completely acceptable), measuring the acceptability of the motion sensor examination in patients and controls.
Time frame: Baseline
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