Parkinson Disease
Conditions
Keywords
Parkinson, Internal tremor, Tremor, Wearable devices, Accelerometer, Parkinson's disease
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.
Interventions
DIAGNOSTIC_TESTDetection of objective internal tremors
head-mounted motion sensors
Sponsors
University Hospital, Toulouse
Fondation de l'Avenir
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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 * 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 * Major osteoarticular problems * Neurological condition that may affect gait (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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in intensity of the peak power at 4-6 Hz | Baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Association between subjective internal tremors and frequency peak between 4 and 6 Hz | Baseline | 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. |
| Association between Objective Internal Tremor and Motor Symptom Severity in Parkinson's Disease as Assessed by the MDS-UPDRS | Baseline | 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. |
| Evaluation of Objective Internal Tremor Powers Detected by Different Sensors in Parkinson's Disease | Baseline | 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. |
| Evaluation of Acceptability of Motion Sensor Examination Using the Visual Analog Scale | Baseline | 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. |
Countries
France
Contacts
CONTACTAna Raquel PINHEIRO BARBOSA
Outcome results
None listed