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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05404867
Recruitment Status : Recruiting
First Posted : June 3, 2022
Last Update Posted : June 15, 2022
Sponsor:
Information provided by (Responsible Party):
Vijay Renga, 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.

Condition or disease Intervention/treatment
Amyotrophic Lateral Sclerosis Other: fMRI

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.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Study of Structural and Functional Brain Connectivity Changes in ALS (CoALS-II)
Actual Study Start Date : June 8, 2022
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : December 2023


Group/Cohort Intervention/treatment
ALS patients
Patients with ALS
Other: fMRI
fMRI scan for 1 hour

Healthy controls
Age-matched healthy controls
Other: fMRI
fMRI scan for 1 hour




Primary Outcome Measures :
  1. fMRI [ Time Frame: 1 hour ]
    Brain network generation and analysis will be performed for anatomical and functional imaging



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
ALS patients and age-matched healthy controls
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05404867


Locations
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United States, New Hampshire
Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Charlotte Jeffreys, MLS    603-650-3834    charlotte.a.jeffreys@hitchcock.org   
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
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Responsible Party: Vijay Renga, Assistant Professor of Neurology, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT05404867    
Other Study ID Numbers: STUDY02001218
First Posted: June 3, 2022    Key Record Dates
Last Update Posted: June 15, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vijay Renga, Dartmouth-Hitchcock Medical Center:
Amyotrophic Lateral Sclerosis
Functional Magnetic Resonance Imaging
Connectivity
Diffusion Tensor Imaging
Dynamometer
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases