NCT05358431: STRATALS

Stratification of Presymptomatic Amyotrophic Lateral Sclerosis: the Development of Novel Imaging Biomarkers

Status unknown NA Last updated 20 February 2024

What this trial tests

NA trial testing Neuroimaging and electrophysiology in Amyotrophic Lateral Sclerosis in 120 participants. Status unknown.

Timeline

21 July 2022

Primary endpoint
21 February 2026

21 February 2026

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	120
Start date	21 July 2022
Primary completion	21 February 2026
Estimated completion	21 February 2026
Sites	1 location across France

Drugs / interventions tested

• Neuroimaging and electrophysiology

Conditions studied

• Amyotrophic Lateral Sclerosis — all drugs for Amyotrophic Lateral Sclerosis →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

18 and older, any sex, with Amyotrophic Lateral Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Amyotrophic lateral sclerosis (ALS) is a relentlessly progressive neurodegenerative disorder with no effective disease-modifying therapies at present. The disease is sporadic in 90 % of the ALS patients. Up to 40 % familial ALS cases and up to 25% of familial frontotemporal dementia (FTD) are caused by autosomal dominant GGGGCC hexanucleotide repeat expansions in the C9orf72 gene. The presymptomatic phase of the disease represents a unique opportunity to evaluate mechanisms of disease propagation, characterise patterns of anatomical spread, validate staging systems and appraise the comparative sensitivity profile of emerging imaging modalities. Very few spinal cord imaging studies currently exist in ALS despite their potential to characterise both the lower and upper motor neuron components of the disease. This prospective longitudinal study of asymptomatic and symptomatic c9orf72 hexanucleotide carriers will use a purpose-designed spinal and brain imaging protocol and comprehensive clinical, genetic, electrophysiological and neuropsychological profiling. Newly developed imaging techniques such as spinal cord NODDI, spinal fMRI, quantitative thoracic cord imaging will be implemented in addition to established spinal cord and brain imaging techniques.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Quantifying multimodal longitudinal brain changes in presymptomatic C9orf72 disease.
   Saracino D, Cipriano L, Houot M, Querin G, et al · · 2025 · cited 1× · PMID 41366786 · DOI 10.1002/alz.70902