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

Dartmouth Health logo

Dartmouth Health

Status

Completed

Conditions

Amyotrophic Lateral Sclerosis

Treatments

Other: fMRI

Study type

Interventional

Funder types

Other

Identifiers

NCT05404867
STUDY02001218

Details and patient eligibility

About

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.

Full 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.

Enrollment

31 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

31 participants in 2 patient groups

ALS patients
Other group
Description:
Patients with ALS
Treatment:
Other: fMRI
Healthy controls
Other group
Description:
Age-matched healthy controls
Treatment:
Other: fMRI

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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