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

Not Applicable

Completed

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Other: fMRI

• Registration Number: NCT05404867
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

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.

Study Timeline

• Study First Submitted: 2022-05-31
• Study First Submitted QC: 2022-05-31
• Study First Posted: 2022-06-03
• Study Start: 2022-06-08
• Primary Completion: 2023-06-30
• Status Verified: 2023-07
• Study Completion: 2024-01-08
• Last Update Submitted: 2024-01-08
• Last Update Posted: 2024-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ALS patients	fMRI	Patients with ALS
Healthy controls	fMRI	Age-matched healthy controls

Primary Outcome Measures

Name	Time	Method
fMRI	1 hour	Brain network generation and analysis will be performed for anatomical and functional imaging

Trial Locations

Locations (1)

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States