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Harmonic Ratio in Patients With GLUT1 Deficiency Syndrome

StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 30, 2024 (before its estimated December 31, 2024 completion). Its status may not reflect the trial's current state.

Record History

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  1. Minor Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 25 to confirmed 32
    • Secondary endpoints: details revised at 4 of 10 entries
    • Site details revised at 2 of 2 sites
    v4
  2. Minor Secondary endpoints: details revised at 2 of 10 entries
    • Study description expanded, about 1 word
    v3
  3. Minor Study description shortened, about 4 wordsv2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Glucose transporter deficiency syndrome type 1 (GLUT1DS) is a rare, genetically determined, neurometabolic disorder . It is estimated that about 90% of affected patients present various pathological gait patterns. Ataxic, spastic, ataxo-spastic, or dystonic walking are the main manifestations described to date. The kinematic gait analysis with inertial sensors represents a method that is easily applicable in clinical practice, with possible application in numerous neurological syndromes of the pediatric and adult age. Through the kinematic gait analysis, it will be possible to obtain an accurate characterization of the gait of patients with GLUT1DS. This will allow, in the first place, a better knowledge of locomotor parameters in this rare cohort of patients. Given that kinematic analysis through a wearable sensor is a method that can be easily integrated into daily clinical practice, the data obtained could become prognostic biomarkers and significant outcome measures of the disease (also in relation to possible improvements deriving from treatment with a ketogenic diet or in the context of future pharmacological trials).
Trial Details
NCT Number NCT05887739
Lead Sponsor IRCCS National Neurological Institute "C. Mondino" Foundation
Collaborators: University of Roma La Sapienza
Conditions
(from sponsor)
GLUT1DS1, Dystonia, Gait Disorders, Neurologic, Gait Ataxia
Related terms Dystonia, Gait Ataxia, Gait Disorders, Neurologic
Enrollment 32 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov