NCT07570459

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
5mo left

Started Jul 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress79%
Jul 2024Oct 2026

Study Start

First participant enrolled

July 30, 2024

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2026

Completed
27 days until next milestone

First Posted

Study publicly available on registry

May 6, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2026

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

1.9 years

First QC Date

April 9, 2026

Last Update Submit

April 29, 2026

Conditions

Keywords

Tremor in CMT

Outcome Measures

Primary Outcomes (4)

  • Activities of Daily Living -Questionaire(ADL)

    baseline

  • Assessment of Handicap - Questionaire

    baseline

  • Fahn Tolosa Marin Rating Scale

    baseline

  • Electrophysiological characterization of tremor using surface EMG and accelerometer analysis

    baseline

Secondary Outcomes (2)

  • MDS-UPDRS Part III without Tremor

    baseline

  • SARA Score

    baseline

Study Arms (2)

CMT patients

Controls

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

CMT-patients and healthy controls

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy or breastfeeding period
  • Other relevant neurological or psychiatric disorders, acute or in the past history
  • Presence of a serious previous internal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre

Göttingen, Lower Saxony, 37075, Germany

RECRUITING

MeSH Terms

Conditions

Charcot-Marie-Tooth Disease

Condition Hierarchy (Ancestors)

Hereditary Sensory and Motor NeuropathyNervous System MalformationsNervous System DiseasesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesPolyneuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, Inborn

Central Study Contacts

Michael W Sereda, Prof. MD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Michael Sereda MD

Study Record Dates

First Submitted

April 9, 2026

First Posted

May 6, 2026

Study Start

July 30, 2024

Primary Completion (Estimated)

July 5, 2026

Study Completion (Estimated)

October 30, 2026

Last Updated

May 6, 2026

Record last verified: 2026-04

Locations