Detection of Internal Tremors by Oscillometry in Parkinson's Patient

NCT06885541 | Recruiting

• 2 other identifiers: RC31/25/00282025-A00133-46
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Parkinson; Internal tremor; Tremor; Wearable devices; Accelerometer; Parkinson's disease

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline

Secondary Outcomes (4)

• Association between subjective internal tremors and frequency peak between 4 and 6 Hz

  Baseline

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

  Baseline

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

  Baseline

• Evaluation of Acceptability of Motion Sensor Examination Using the Visual Analog Scale

  Baseline

Study Arms (2)

Parkinson's disease patients

OTHER

Parkinson's disease patient in the off phase.

Diagnostic Test: Detection of objective internal tremors

Healthy participants

OTHER

Healthy participants

Diagnostic Test: Detection of objective internal tremors

Interventions

Detection of objective internal tremors DIAGNOSTIC_TEST

head-mounted motion sensors

Healthy participants; Parkinson's disease patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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

You may not qualify if:

• (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

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• Fondation de l'Avenir: collaborator

Study Sites (1)

Purpan Hospital

Toulouse, Occitanie, 31059, France

RECRUITING

Related Publications (16)

• Mendonca MD, Ferreira PC, Oliveira F, Barbosa R, Meira B, Costa DC, Oliveira-Maia AJ, da Silva JA. Relative sparing of dopaminergic terminals in the caudate nucleus is a feature of rest tremor in Parkinson's disease. NPJ Parkinsons Dis. 2024 Nov 18;10(1):209. doi: 10.1038/s41531-024-00818-8.

  PMID: 39557871 BACKGROUND

• Schrag A, Bohlken J, Dammertz L, Teipel S, Hermann W, Akmatov MK, Batzing J, Holstiege J. Widening the Spectrum of Risk Factors, Comorbidities, and Prodromal Features of Parkinson Disease. JAMA Neurol. 2023 Feb 1;80(2):161-171. doi: 10.1001/jamaneurol.2022.3902.

  PMID: 36342675 BACKGROUND

• Cochrane GD, Rizvi S, Abrantes A, Crabtree B, Cahill J, Friedman JH. Internal tremor in Parkinson's disease, multiple sclerosis, and essential tremor. Parkinsonism Relat Disord. 2015 Oct;21(10):1145-7. doi: 10.1016/j.parkreldis.2015.07.014. Epub 2015 Jul 18.

  PMID: 26307481 BACKGROUND

• Shulman LM, Singer C, Bean JA, Weiner WJ. Internal tremor in patients with Parkinson's disease. Mov Disord. 1996 Jan;11(1):3-7. doi: 10.1002/mds.870110103.

  PMID: 8771060 BACKGROUND

• Bhatia KP, Bain P, Bajaj N, Elble RJ, Hallett M, Louis ED, Raethjen J, Stamelou M, Testa CM, Deuschl G; Tremor Task Force of the International Parkinson and Movement Disorder Society. Consensus Statement on the classification of tremors. from the task force on tremor of the International Parkinson and Movement Disorder Society. Mov Disord. 2018 Jan;33(1):75-87. doi: 10.1002/mds.27121. Epub 2017 Nov 30.

  PMID: 29193359 BACKGROUND

• Abusrair AH, Elsekaily W, Bohlega S. Tremor in Parkinson's Disease: From Pathophysiology to Advanced Therapies. Tremor Other Hyperkinet Mov (N Y). 2022 Sep 13;12:29. doi: 10.5334/tohm.712. eCollection 2022.

  PMID: 36211804 BACKGROUND

• Poewe W, Seppi K, Tanner CM, Halliday GM, Brundin P, Volkmann J, Schrag AE, Lang AE. Parkinson disease. Nat Rev Dis Primers. 2017 Mar 23;3:17013. doi: 10.1038/nrdp.2017.13.

  PMID: 28332488 BACKGROUND

• Jennings D, Siderowf A, Stern M, Seibyl J, Eberly S, Oakes D, Marek K; PARS Investigators. Conversion to Parkinson Disease in the PARS Hyposmic and Dopamine Transporter-Deficit Prodromal Cohort. JAMA Neurol. 2017 Aug 1;74(8):933-940. doi: 10.1001/jamaneurol.2017.0985.

  PMID: 28595287 BACKGROUND

• Postuma RB, Iranzo A, Hu M, Hogl B, Boeve BF, Manni R, Oertel WH, Arnulf I, Ferini-Strambi L, Puligheddu M, Antelmi E, Cochen De Cock V, Arnaldi D, Mollenhauer B, Videnovic A, Sonka K, Jung KY, Kunz D, Dauvilliers Y, Provini F, Lewis SJ, Buskova J, Pavlova M, Heidbreder A, Montplaisir JY, Santamaria J, Barber TR, Stefani A, St Louis EK, Terzaghi M, Janzen A, Leu-Semenescu S, Plazzi G, Nobili F, Sixel-Doering F, Dusek P, Bes F, Cortelli P, Ehgoetz Martens K, Gagnon JF, Gaig C, Zucconi M, Trenkwalder C, Gan-Or Z, Lo C, Rolinski M, Mahlknecht P, Holzknecht E, Boeve AR, Teigen LN, Toscano G, Mayer G, Morbelli S, Dawson B, Pelletier A. Risk and predictors of dementia and parkinsonism in idiopathic REM sleep behaviour disorder: a multicentre study. Brain. 2019 Mar 1;142(3):744-759. doi: 10.1093/brain/awz030.

  PMID: 30789229 BACKGROUND

• Mahlknecht P, Seppi K, Poewe W. The Concept of Prodromal Parkinson's Disease. J Parkinsons Dis. 2015;5(4):681-97. doi: 10.3233/JPD-150685.

  PMID: 26485429 BACKGROUND

• Berg D, Postuma RB, Adler CH, Bloem BR, Chan P, Dubois B, Gasser T, Goetz CG, Halliday G, Joseph L, Lang AE, Liepelt-Scarfone I, Litvan I, Marek K, Obeso J, Oertel W, Olanow CW, Poewe W, Stern M, Deuschl G. MDS research criteria for prodromal Parkinson's disease. Mov Disord. 2015 Oct;30(12):1600-11. doi: 10.1002/mds.26431.

  PMID: 26474317 BACKGROUND

• Berg D, Borghammer P, Fereshtehnejad SM, Heinzel S, Horsager J, Schaeffer E, Postuma RB. Prodromal Parkinson disease subtypes - key to understanding heterogeneity. Nat Rev Neurol. 2021 Jun;17(6):349-361. doi: 10.1038/s41582-021-00486-9. Epub 2021 Apr 20.

  PMID: 33879872 BACKGROUND

• Heim B, Krismer F, De Marzi R, Seppi K. Magnetic resonance imaging for the diagnosis of Parkinson's disease. J Neural Transm (Vienna). 2017 Aug;124(8):915-964. doi: 10.1007/s00702-017-1717-8. Epub 2017 Apr 4.

  PMID: 28378231 BACKGROUND

• Postuma RB, Berg D, Stern M, Poewe W, Olanow CW, Oertel W, Obeso J, Marek K, Litvan I, Lang AE, Halliday G, Goetz CG, Gasser T, Dubois B, Chan P, Bloem BR, Adler CH, Deuschl G. MDS clinical diagnostic criteria for Parkinson's disease. Mov Disord. 2015 Oct;30(12):1591-601. doi: 10.1002/mds.26424.

  PMID: 26474316 BACKGROUND

• Dorsey ER, Sherer T, Okun MS, Bloem BR. The Emerging Evidence of the Parkinson Pandemic. J Parkinsons Dis. 2018;8(s1):S3-S8. doi: 10.3233/JPD-181474.

  PMID: 30584159 BACKGROUND

• Bloem BR, Okun MS, Klein C. Parkinson's disease. Lancet. 2021 Jun 12;397(10291):2284-2303. doi: 10.1016/S0140-6736(21)00218-X. Epub 2021 Apr 10.

  PMID: 33848468 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Tremor

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Ana Raquel PINHEIRO BARBOSA

CONTACT

(+33) 05.61.77.99.30; pinheirobarbosa.ar@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 20, 2025
• Study Start: February 10, 2026
• Primary Completion (Estimated): May 10, 2027
• Study Completion (Estimated): May 10, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

FR (1)