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

January 8, 2024 updated by: Dartmouth-Hitchcock Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Study Population

ALS patients and age-matched healthy controls

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: ALS patients
Patients with ALS
Other: fMRI
fMRI scan for 1 hour
Other: Healthy controls
Age-matched healthy controls
Other: fMRI
fMRI scan for 1 hour

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2022

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

January 8, 2024

Study Registration Dates

First Submitted

May 31, 2022

First Submitted That Met QC Criteria

May 31, 2022

First Posted (Actual)

June 3, 2022

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY02001218

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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