Detection of Internal Tremors by Oscillometry in Parkinson's Patient

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест Detection of objective internal tremors
  head-mounted motion sensors

Первичные конечные точки

• Difference in intensity of the peak power at 4-6 Hz [Срок оценки: Baseline]

Вторичные конечные точки (4)

• Association between subjective internal tremors and frequency peak between 4 and 6 Hz [Срок оценки: Baseline]
• Association between Objective Internal Tremor and Motor Symptom Severity in Parkinson's Disease as Assessed by the MDS-UPDRS [Срок оценки: Baseline]
• Evaluation of Objective Internal Tremor Powers Detected by Different Sensors in Parkinson's Disease [Срок оценки: Baseline]
• Evaluation of Acceptability of Motion Sensor Examination Using the Visual Analog Scale [Срок оценки: Baseline]

Критерии участия

Критерии включения

(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

Критерии исключения

(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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Франция · 1 центр

• Purpan Hospital — Toulouse

Публикации

• 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
• 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
• 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
• 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
• 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 No PMID 29193359
• 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
• 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
• 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

Идентификаторы

NCT: NCT06885541 · RC31/25/0028 · 2025-A00133-46

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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