Study of Structural and Functional Brain Connectivity Changes in ALS (CoALS-II)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05404867

Acronym

CoALS-II

Enrollment

Registered

2022-06-03

Start date

2022-06-08

Completion date

2024-01-08

Last updated

2024-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Amyotrophic Lateral Sclerosis, Functional Magnetic Resonance Imaging, Connectivity, Diffusion Tensor Imaging, Dynamometer

Brief summary

This study will try to understand the difference in brain structure between ALS patients and healthy people of similar age. ALS is a condition affecting the nervous system with disruption of the brain networks. This study aims to understand these disruptions and determine their significance in ALS.

Detailed description

Participants and healthy controls will be consented into the study. After consent, details including age, duration of disease, ALSFRS score, and grip strength will be collected. Participants will be trained to perform a grip and release task using a foam ball for 1 minute while inside an MRI scanner. Anatomical, functional and diffusion MRI sequences will be acquired during the scanning, and total scan time will be approximately 1 hour.

Interventions

OTHERfMRI

fMRI scan for 1 hour

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Based on El Escorial Criteria we will select Probable or Definite ALS. * Healthy controls age matched to ALS patients * Subjects should be able to lie down in a scanner and undergo an hour-long MRI study * Subjects should be able to understand instructions, provide consent and perform a hand task while inside the scanner

Exclusion criteria

* Unable to undergo MRI due to any reason * Age \<18 * ALS patients having high aspiration risk * Patients having cognitive limitations which prevents them from understanding the study requirements, providing consent or perform tasks inside the scanner.

Design outcomes

Primary

Measure	Time frame	Description
fMRI	1 hour	Brain network generation and analysis will be performed for anatomical and functional imaging

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026