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

February 12, 2026 updated by: University Hospital, Toulouse

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Parkinson's disease patients
Parkinson's disease patient in the off phase.
Diagnostic test: Detection of objective internal tremors
head-mounted motion sensors
Other: Healthy participants
Diagnostic test: Detection of objective internal tremors
head-mounted motion sensors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
Baseline
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.
Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Collaborators

Fondation de l'Avenir

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2026

Primary Completion (Estimated)

May 10, 2027

Study Completion (Estimated)

May 10, 2027

Study Registration Dates

First Submitted

February 27, 2025

First Submitted That Met QC Criteria

March 19, 2025

First Posted (Actual)

March 20, 2025

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/25/0028
  • 2025-A00133-46 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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