Skip to main content
OpenTrials
Completed

NCT Number: NCT05404867

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

fMRI

Other

fMRI scan for 1 hour

Primary outcomes

  1. fMRI

    Time frame: 1 hour

    Brain network generation and analysis will be performed for anatomical and functional imaging

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Acronym: CoALS-II

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jun 3, 2022
Registry last updated
Jan 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.