- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07570459
TREMOR IN CHARCOT-MARIE-TOOTH (CMT-TREM)
Investigation of Tremor in Patients With Charcot-Marie-Tooth Neuropathy
Tremor is a symptom that has already been described in many case reports and case series concerning patients with Charcot-Marie-Tooth (CMT) disease. However, the pathophysiology of tremor in this condition remains largely unclear. It has also not been sufficiently investigated to what extent tremor in CMT patients constitutes a relevant impairment of quality of life.
This project focuses on a more detailed characterization of tremor in CMT patients using surface electromyography and accelerometer analysis, as well as the collection of individual clinical data, particularly regarding the symptom of tremor, in order to facilitate the characterization and etiological classification of the tremor. In addition, a questionnaire-based assessment will be conducted to capture the impact of tremor on activities of daily living and the associated burden in this specific patient cohort.
The entire data collection process will be supported by a clinical examination, which will be video-recorded by experienced neurologists to ensure more reliable analysis. This serves both the characterization of tremor and the illustration of its functional limitations. Where available, the data will be correlated with genetic variants to allow conclusions about possible genetic predispositions or disease progression. As a control group, CMT patients who have not yet reported a tremor will be included.
Studieoversigt
Status
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Michael W Sereda, Prof. MD
- Telefonnummer: +49 551 3964162
- E-mail: sereda@mpinat.mpg.de
Studiesteder
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Lower Saxony
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Göttingen, Lower Saxony, Tyskland, 37075
- Rekruttering
- University Medical Centre
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Kontakt:
- Sandrin Plewe
- Telefonnummer: +49 551 3964162
- E-mail: sandrin.plewe@med.uni-goettingen.de
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Clinical CMT Diagnosis / Anamnestically Healthy Control Group
- Genetic confirmation of CMT in adult patients
- Ability to achieve the outcome measure at baseline
- Age between 18 and 65 years
- Capacity of all study participants to consent and signed informed consent, including patient or participant information and consent form
Exclusion Criteria:
- Pregnancy or breastfeeding period
- Other relevant neurological or psychiatric disorders, acute or in the past history
- Presence of a serious previous internal disease
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Kontrolelementer
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CMT -patienter
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Activities of Daily Living -Questionaire(ADL)
Tidsramme: baseline
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baseline
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Assessment of Handicap - Questionaire
Tidsramme: baseline
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baseline
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Fahn Tolosa Marin Rating Scale
Tidsramme: baseline
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baseline
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Electrophysiological characterization of tremor using surface EMG and accelerometer analysis
Tidsramme: baseline
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baseline
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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MDS-UPDRS Part III without Tremor
Tidsramme: baseline
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baseline
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SARA Score
Tidsramme: baseline
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baseline
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i nervesystemet
- Neuromuskulære sygdomme
- Genetiske sygdomme, medfødte
- Sygdomme i det perifere nervesystem
- Neurodegenerative sygdomme
- Medfødte abnormiteter
- Heredodegenerative lidelser, nervesystem
- Misdannelser i nervesystemet
- Polyneuropatier
- Arvelig sensorisk og motorisk neuropati
- Medfødte, arvelige og neonatale sygdomme og abnormiteter
- Charcot-Marie-Tooth sygdom
Andre undersøgelses-id-numre
- 17/05/2024_C3
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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