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NCT Number: NCT06885541

Detection of Internal Tremors by Oscillometry in Parkinson's Patient

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Dyskinesias Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies Tremor

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Purpan Hospital

Toulouse, Occitanie, 31059, France

Location status: Recruiting

Location contact

Ana Raquel PINHEIRO BARBOSA

CONTACT

[email protected]

0561779930

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Detection of objective internal tremors

Diagnostic Test

head-mounted motion sensors

Primary outcomes

  1. Difference in intensity of the peak power at 4-6 Hz

    Time frame: 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 outcomes

  1. Association between subjective internal tremors and frequency peak between 4 and 6 Hz

    Time frame: 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.

  2. Association between Objective Internal Tremor and Motor Symptom Severity in Parkinson's Disease as Assessed by the MDS-UPDRS

    Time frame: 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.

  3. Evaluation of Objective Internal Tremor Powers Detected by Different Sensors in Parkinson's Disease

    Time frame: 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.

  4. Evaluation of Acceptability of Motion Sensor Examination Using the Visual Analog Scale

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ana Raquel PINHEIRO BARBOSA

CONTACT

[email protected]

(+33) 05.61.77.99.30

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Collaborators

  • Fondation de l'Avenir

Registry information

Official study title

Detection of Internal Tremors by Oscillometry in Parkinson's Patient : a Pilot Study

Acronym: TREMOS-PD

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 20, 2025
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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