Detection of Internal Tremors by Oscillometry in Parkinson's Patient

NCT ID: NCT06885541

Last Updated: 2025-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-31

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Parkinson Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Parkinson's disease patients

Parkinson's disease patient in the off phase.

Group Type OTHER

Detection of objective internal tremors

Intervention Type DIAGNOSTIC_TEST

head-mounted motion sensors

Healthy participants

Healthy participants

Group Type OTHER

Detection of objective internal tremors

Intervention Type DIAGNOSTIC_TEST

head-mounted motion sensors

Interventions

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Detection of objective internal tremors

head-mounted motion sensors

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
* No major osteoarticular issues
* Presence of another neurological condition that may affect gait
* 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

(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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fondation de l'Avenir

OTHER

Sponsor Role collaborator

University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Purpan Hospital

Toulouse, Occitanie, France

Site Status

Countries

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France

Central Contacts

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Ana Raquel PINHEIRO BARBOSA

Role: CONTACT

(+33) 05.61.77.99.30

Facility Contacts

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Ana Raquel PINHEIRO BARBOSA

Role: primary

0561779930

References

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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.

Reference Type BACKGROUND
PMID: 26307481 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8771060 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39557871 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36342675 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29193359 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36211804 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28332488 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28595287 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30789229 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26485429 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26474317 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33879872 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28378231 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26474316 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30584159 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33848468 (View on PubMed)

Other Identifiers

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2025-A00133-46

Identifier Type: OTHER

Identifier Source: secondary_id

RC31/25/0028

Identifier Type: -

Identifier Source: org_study_id

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