Clinical Trial

Harmonic Ratio in Patients With GLUT1 Deficiency Syndrome

Active, Not Recruiting
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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.
Summary
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).
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-05-24; most recent amendment 2024-04-27.
Status change: Recruiting → Active, Not Recruiting 2024-04-27
Trial Details
NCT Number NCT05887739
Lead Sponsor IRCCS National Neurological Institute "C. Mondino" Foundation
Collaborators: University of Roma La Sapienza
Conditions GLUT1DS1, Dystonia, Gait Disorders, Neurologic, Gait Ataxia
Enrollment 32 participants
Start Date 2023-01-01
Primary Completion 2024-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-04-30