NCT05404867

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 3, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

June 8, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2024

Completed
Last Updated

January 9, 2024

Status Verified

July 1, 2023

Enrollment Period

1.1 years

First QC Date

May 31, 2022

Last Update Submit

January 8, 2024

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Amyotrophic Lateral SclerosisFunctional Magnetic Resonance ImagingConnectivityDiffusion Tensor ImagingDynamometer

Outcome Measures

Primary Outcomes (1)

  • fMRI

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

    1 hour

Study Arms (2)

ALS patients

OTHER

Patients with ALS

Other: fMRI

Healthy controls

OTHER

Age-matched healthy controls

Other: fMRI

Interventions

fMRIOTHER

fMRI scan for 1 hour

ALS patientsHealthy controls

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2022

First Posted

June 3, 2022

Study Start

June 8, 2022

Primary Completion

June 30, 2023

Study Completion

January 8, 2024

Last Updated

January 9, 2024

Record last verified: 2023-07

Locations

US(1)