Amyotrophic Lateral SclerosisCoALS-IINCT05404867
Study of Structural and Functional Brain Connectivity Changes in ALS (CoALS-II)
A study testing fMRI in people with Amyotrophic Lateral Sclerosis, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- fMRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2022to 8 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
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.
Read the 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.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- fMRI
- Keywords
- Amyotrophic Lateral Sclerosis, Functional Magnetic Resonance Imaging, Connectivity, Diffusion Tensor Imaging, Dynamometer
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRIOther
fMRI scan for 1 hour
| Study group | Role | What they receive |
|---|---|---|
| ALS patients | Other | Patients with ALS Receives: Other: fMRI |
| Healthy controls | Other | Age-matched healthy controls Receives: Other: fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI
Brain network generation and analysis will be performed for anatomical and functional imaging
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start8 Jun 2022
- Primary completion30 Jun 2023
- Study completion8 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05404867
- Sponsor's protocol ID
- STUDY02001218
- Acronym
- CoALS-II
- Status last verified
- Jul 2023
- First submitted
- 31 May 2022
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Structural and Functional Brain Connectivity Changes in ALS (CoALS-II)
- ClinicalTrials.gov ID
- NCT05404867
- Acronym / sponsor ID
- CoALS-II / STUDY02001218
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Amyotrophic Lateral Sclerosis, Functional Magnetic Resonance Imaging, Connectivity, Diffusion Tensor Imaging, Dynamometer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 8 Jun 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 8 Jan 2024 (actual)
- First posted
- 3 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALS patients | Other | Other: fMRIPatients with ALS |
| Healthy controls | Other | Other: fMRIAge-matched healthy controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fMRIfMRI scan for 1 hour | Other | ALS patients, Healthy controls |
Primary outcome
fMRI
Time frame: 1 hour
Brain network generation and analysis will be performed for anatomical and functional imaging
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fMRI in people with Amyotrophic Lateral Sclerosis, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fMRI (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024.