NCT04154540

Brief Summary

If the classification between hereditary and acquired neuropathy is often easy, there is no completely specific marker allowing the distinction between the two etiologies. Clinical experience suggests that hereditary neuropathies have less impact on balance and gait than the acquired neuropathies at equivalent level of impairment, but this has never been clearly demonstrated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 6, 2019

Completed
1.5 years until next milestone

Study Start

First participant enrolled

May 19, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2024

Completed
Last Updated

December 11, 2025

Status Verified

December 1, 2025

Enrollment Period

2.7 years

First QC Date

August 14, 2019

Last Update Submit

December 4, 2025

Conditions

Neuropathy Demyelinating

Keywords

GaitBalancePostureCharcot-Marie-ToothChronic inflammatory demyelinating polyneuropathy

Outcome Measures

Primary Outcomes (1)

  • Posturography (Romberg's quotient)

    Time 0 ; single session

Secondary Outcomes (5)

  • The Timed Up and Go test (TUG)

    Time 0 ; single session

  • stride length (in millimeters) parameters

    Time 0 ; single session

  • stride time (in seconde) parameters

    Time 0 ; single session

  • velocity (meter/seconde) parameters

    Time 0 ; single session

  • cadence (step/min) parameters

    Time 0 ; single session

Study Arms (2)

demyelinating hereditary neuropathy

EXPERIMENTAL

adult patients with demyelinating hereditary neuropathy type CMT 1A.

Other: Motion analysis

demyelinating inflammatory neuropathy

EXPERIMENTAL

adult patients with acquired demyelinating inflammatory neuropathy.

Other: Motion analysis

Interventions

Motion analysisOTHER

Gait and posture recording

demyelinating hereditary neuropathydemyelinating inflammatory neuropathy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • CMT1A for molecular-proven Group 1 (PMP22 duplication)
  • IPDC likely or defined for Group 2
  • Able to walk 10 m unassisted

You may not qualify if:

  • Neurological history other than neuropathy: epilepsy, stroke, dementia
  • Pregnant women
  • Person under guardianship or trusteeship
  • Musculoskeletal conditions other than neuropathy impairing walking abilities
  • Major comorbidity considered a contraindication by the investigator (cancer, unstable angor, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Roger Salengro, CHU

Lille, France

Location

Related Publications (1)

  • Dupont L, Defebvre L, Davion JB, Delval A, Tard C. Postural balance and visual dependence in patients with demyelinating neuropathies differ between acquired and hereditary etiologies. Rev Neurol (Paris). 2025 Jan-Feb;181(1-2):98-105. doi: 10.1016/j.neurol.2024.10.002. Epub 2024 Oct 28.

    PMID: 39462724RESULT

MeSH Terms

Conditions

Charcot-Marie-Tooth DiseasePolyradiculoneuropathy, Chronic Inflammatory Demyelinating

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, InbornPolyradiculoneuropathyAutoimmune Diseases of the Nervous SystemDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Céline TARD, MD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2019

First Posted

November 6, 2019

Study Start

May 19, 2021

Primary Completion

January 19, 2024

Study Completion

January 19, 2024

Last Updated

December 11, 2025

Record last verified: 2025-12

Locations

FR(1)