- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Michael W Sereda, Prof. MD
- Phone Number: +49 551 3964162
- Email: sereda@mpinat.mpg.de
Study Locations
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Lower Saxony
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Göttingen, Lower Saxony, Germany, 37075
- Recruiting
- University Medical Centre
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Contact:
- Sandrin Plewe
- Phone Number: +49 551 3964162
- Email: sandrin.plewe@med.uni-goettingen.de
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Controls
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CMT patients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Activities of Daily Living -Questionaire(ADL)
Time Frame: baseline
|
baseline
|
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Assessment of Handicap - Questionaire
Time Frame: baseline
|
baseline
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Fahn Tolosa Marin Rating Scale
Time Frame: baseline
|
baseline
|
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Electrophysiological characterization of tremor using surface EMG and accelerometer analysis
Time Frame: baseline
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
MDS-UPDRS Part III without Tremor
Time Frame: baseline
|
baseline
|
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SARA Score
Time Frame: baseline
|
baseline
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neuromuscular Diseases
- Genetic Diseases, Inborn
- Peripheral Nervous System Diseases
- Neurodegenerative Diseases
- Congenital Abnormalities
- Heredodegenerative Disorders, Nervous System
- Nervous System Malformations
- Polyneuropathies
- Hereditary Sensory and Motor Neuropathy
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Charcot-Marie-Tooth Disease
Other Study ID Numbers
- 17/05/2024_C3
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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