ALS - Amyotrophic Lateral SclerosisNCT07818772
7T Imaging Pilot-study in Patients With Motor Neuron Disease to Find Non-Invasive Disease Imaging Biomarkers
An observational study of ALS - Amyotrophic Lateral Sclerosis, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial summary
Motor Neuron Disease (MND) is a neurodegenerative disorder, which causes progressive loss of nerve cells controlling the muscles responsible for movement, speech, swallowing and breathing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ALS - Amyotrophic Lateral Sclerosis
- What is being tested?
- MRI
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Apr 2026to 30 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with MND, including subtypes Amyotrophic Lateral Sclerosis (ALS), Primary Lateral Sclerosis (PLS), Progressive Muscular Atrophy (PMA), Progressive Bulbar Palsy (PBP) will be included in the study. Target number of subjects is 30, split into two groups of 15 (scanned on two different coils with different anatomical cover of brainstem and upper cord). These patients will be identified by their clinical Neurology and MND team.
Who may be able to join
- Male or non-pregnant female patients, ≥18 years of age
- Able to give informed consent
- Patients diagnosed as definite or probable motor neuron disease (El Escorial Criteria)
Who cannot join
- Contraindications to 7T MRI;
- active implants,
- tattoos in head and neck area
- post-surgical brain implants and metal ware
- Pregnancy
- Unable to comfortably or safely lie flat in an MRI scanner
Show all 11Show fewer
- Respiratory failure
- Known major other confounding neurological disease or previous brain surgery
- Significant cognitive impairment, including loss of capacity secondary to fronto-temporal dementia
- Unable to speak or understand any English (not complying with local 7T MRI safety SOPs)
- Unlikely to be able to lie still for the duration of the scan.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
ICE Building
Glasgow, G514TF
George H Gorrie, PhD, 01412327542, george.gorrie2@nhs.scot
About this study
Motor Neuron Disease (MND) is a neurodegenerative disorder, which causes progressive loss of nerve cells controlling the muscles responsible for movement, speech, swallowing and breathing. MND is not actually a single disease, but a range of diseases; some more serious with patients dying within a year, and some less severe cases with a life expectancy of several years. It is often difficult and can take a long time to get a diagnosis of MND, by which time patients are often already very unwell.
The aim of this research study is to improve the diagnosis of MND and make it faster. The investigators plan to achieve this goal by using advanced Magnetic Resonance Imaging (MRI) to develop new diagnostic tests for MND. The investigators will use a scanner with a very strong magnetic field of 7 tesla (7T), which provides images of the brain with increased detail compared to standard MRI scanners, which use magnetic field strengths of 1.5T or 3T. The investigators will use the advanced capability of 7T MRI to identify so-called imaging biomarkers, which are features of the scans that are specific to a particular disease, in this case MND and its different subtypes.
This is a pilot study with a relatively small number of patients. The preliminary findings from this research will be used to design larger follow-on studies aiming to establish a fast and specific diagnosis for patients living with MND. This would allow patients to enter suitable trials faster and would help patients to receive more tailored treatment.
Read the detailed description
The purpose of this pilot study is to develop and assess the feasibility of advanced 7 tesla (7T) MRI brain imaging for patients living with motor neuron disease (MND).
Motor neuron disease (MND) is a spectrum of neurodegenerative disorders, leading to progressive muscle weakness, paralysis and breathing failure. This is characterised pathologically by loss of motor neurons in the motor cortex and anterior horn cells of the spinal cord. Different subtypes of MND, such as Amyotrophic Lateral Sclerosis (ALS) and Primary Lateral Sclerosis (PLS), have different clinical courses, ALS having a short survival and PLS a much longer survival. The causes for this disease remain unknown; however, there is support from genetic studies for protein misfolding impacting on proteostatic mechanisms, contributing to the development of some cases of MND, ALS in particular. Genetic causes for MND have been identified, most frequently involving the SOD1 and C9orf72 genes (Dharmadasa et al, 2022).
There is a need for improved diagnostic approaches to identify MND earlier enabling personalised prognostication, treatment and entry into clinical trials. The development of imaging biomarkers for MND has therefore become more attractive (Zejlon et al, 2022). The different subtypes of MND have variable impacts on patients, with different prognosis and treatment responses. Identification of non-invasive biomarkers, avoiding invasive procedures such as lumbar puncture, could facilitate diagnostic pathways for patients, enable earlier stratification into disease subtypes, and help stratify response to treatment in clinical trials.
This study aims to identify an array of 7 tesla (7T) imaging biomarkers in MND to stratify patients according to different disease subtypes, and to establish a new Scottish diagnostic imaging protocol tailored and suitable for patients suffering from MND. This would be a novel imaging approach, which may form the basis for a future MND imaging biomarker database in Scotland.
7T MRI, compared to lower field strength, offers increased signal-to-noise-ratio, allowing for the acquisition of higher resolution images, greater sensitivity to differences in susceptibility effects, and increased spectral resolution (Schick et al, 2005; Keith et al, 2024). These intrinsic properties of 7T make it an ideal tool in establishing imaging biomarkers for MND (De Vries et al, 2024). The integration of 7T imaging technology and of new imaging biomarkers into the current diagnostic pathway for patients with MND would provide distinct advantages over conventional imaging. Identification of microstructural degenerative changes in the motor cortex of patients with this disorder early in the disease process would increase diagnostic certainty. This is particularly important in a disorder such as MND, which has devastating consequences, yet has no definite diagnostic test or specific biomarker. As more expensive biological therapies come into play in treating MND, identifying response by measuring stabilisation of the motor cortex structural integrity will be important. The detailed structural imaging provided by 7T MRI, combined with genetic information, will drive the development of precision medicine in these individuals.
There has been much interest in potential biomarkers, including imaging biomarkers, in MND over the recent years. We propose taking this further by establishing an array of specific imaging biomarkers for subtypes of MND, and by developing a tailored diagnostic "Biomarker MND Imaging Protocol" for patients, optimised to benefit from the strength of 7T. This would not only help diagnosis of patients suffering from MND but would allow stratification for treatment purposes and monitoring of the effect of possible new treatments.
7T MRI, compared to lower field strength, offers, increased signal-to-noise-ratio, allowing for the acquisition of higher resolution images, greater sensitivity to differences in susceptibility effects, and increased spectral resolution (Schick et al, 2005). These intrinsic properties of 7T make it an ideal tool in establishing imaging biomarkers for MND. The integration of 7T imaging technology and of new imaging biomarkers into the current diagnostic pathway for patients with MND would provide distinct advantages over conventional imaging. Identification of microstructural degenerative changes in the motor cortex of patients with this disorder early in the disease process would increase diagnostic certainty. This is particularly important in a disorder such as MND, which has devastating consequences, yet has no definite diagnostic test or specific biomarker. As more expensive biological therapies come into play in treating MND, identifying response by measuring stabilisation of the motor cortex structural integrity will be important. The detailed structural imaging provided by 7T MRI, combined with genetic information, will drive the development of precision medicine in these individuals.
There is interest in potential biomarkers, including imaging biomarkers, in MND over the recent years. We propose taking this further by establishing an array of specific imaging biomarkers for subtypes of MND, and by developing a tailored diagnostic "Biomarker MND Imaging Protocol" for patients, optimised to benefit from the strength of 7T. This would not only help diagnosis of patients suffering from MND, but would allow stratification for treatment purposes and monitoring of the effect of possible new treatments.
- Conditions
- ALS - Amyotrophic Lateral Sclerosis
- Being tested
- MRI
- Keywords
- 7 Tesla MRI, ALS, Biomarkers
- 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.
MRIDevice
Specialist 7 T head and neck coil and standard 7T Head coil will be evaluated at identifying biomarkers for ALS.
| Study group | Role | What they receive |
|---|---|---|
| Standard Coil | ALS cases Receives: Device: MRI | |
| Head and Neck coil | ALS cases Receives: Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstration of Pathology on 7T MRI
Demonstration of MND pathology on 7T MRI by the identification of atrophy of motor cortex by measurement of the thickness of the motor cortex in mm.
Measured: 2 years
Secondary outcomes (2)
Tolerability of 7 T scanning by ALS patients.
Tolerability of 7T scanning measured by patient experience on Likert scale 1 to 5, with 1 being the best and 5 the worst outcome in MRI experience.
Measured: 2 years
Quality of MRI imaging of ALS patients by 7T system.
Diagnostic quality of 7T MRI images determined by neuroradiologist using Likert scale with 1 being the best quality of scans and 5 being the worst quality of scan.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start13 Apr 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALS - 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Greater Glasgow and Clyde Board HQ
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07818772
- Sponsor's protocol ID
- NorthGlasgowU
- Other IDs
- MN5DF/CAAu23/100025
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Tabulated results for biomarkers will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 7T Imaging Pilot-study in Patients With Motor Neuron Disease to Find Non-Invasive Disease Imaging Biomarkers
- ClinicalTrials.gov ID
- NCT07818772
- Acronym / sponsor ID
- NorthGlasgowU
- Conditions
- ALS - Amyotrophic Lateral Sclerosis
- Keywords
- 7 Tesla MRI, ALS, Biomarkers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- NHS Greater Glasgow and Clyde Board HQ
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 14 Sep 2026 (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.
Motor Neuron Disease (MND) is a neurodegenerative disorder, which causes progressive loss of nerve cells controlling the muscles responsible for movement, speech, swallowing and breathing. MND is not actually a single disease, but a range of diseases; some more serious with patients dying within a year, and some less severe cases with a life expectancy of several years. It is often difficult and can take a long time to get a diagnosis of MND, by which time patients are often already very unwell.
The aim of this research study is to improve the diagnosis of MND and make it faster. The investigators plan to achieve this goal by using advanced Magnetic Resonance Imaging (MRI) to develop new diagnostic tests for MND. The investigators will use a scanner with a very strong magnetic field of 7 tesla (7T), which provides images of the brain with increased detail compared to standard MRI scanners, which use magnetic field strengths of 1.5T or 3T. The investigators will use the advanced capability of 7T MRI to identify so-called imaging biomarkers, which are features of the scans that are specific to a particular disease, in this case MND and its different subtypes.
This is a pilot study with a relatively small number of patients. The preliminary findings from this research will be used to design larger follow-on studies aiming to establish a fast and specific diagnosis for patients living with MND. This would allow patients to enter suitable trials faster and would help patients to receive more tailored treatment.
Detailed description
The purpose of this pilot study is to develop and assess the feasibility of advanced 7 tesla (7T) MRI brain imaging for patients living with motor neuron disease (MND).
Motor neuron disease (MND) is a spectrum of neurodegenerative disorders, leading to progressive muscle weakness, paralysis and breathing failure. This is characterised pathologically by loss of motor neurons in the motor cortex and anterior horn cells of the spinal cord. Different subtypes of MND, such as Amyotrophic Lateral Sclerosis (ALS) and Primary Lateral Sclerosis (PLS), have different clinical courses, ALS having a short survival and PLS a much longer survival. The causes for this disease remain unknown; however, there is support from genetic studies for protein misfolding impacting on proteostatic mechanisms, contributing to the development of some cases of MND, ALS in particular. Genetic causes for MND have been identified, most frequently involving the SOD1 and C9orf72 genes (Dharmadasa et al, 2022).
There is a need for improved diagnostic approaches to identify MND earlier enabling personalised prognostication, treatment and entry into clinical trials. The development of imaging biomarkers for MND has therefore become more attractive (Zejlon et al, 2022). The different subtypes of MND have variable impacts on patients, with different prognosis and treatment responses. Identification of non-invasive biomarkers, avoiding invasive procedures such as lumbar puncture, could facilitate diagnostic pathways for patients, enable earlier stratification into disease subtypes, and help stratify response to treatment in clinical trials.
This study aims to identify an array of 7 tesla (7T) imaging biomarkers in MND to stratify patients according to different disease subtypes, and to establish a new Scottish diagnostic imaging protocol tailored and suitable for patients suffering from MND. This would be a novel imaging approach, which may form the basis for a future MND imaging biomarker database in Scotland.
7T MRI, compared to lower field strength, offers increased signal-to-noise-ratio, allowing for the acquisition of higher resolution images, greater sensitivity to differences in susceptibility effects, and increased spectral resolution (Schick et al, 2005; Keith et al, 2024). These intrinsic properties of 7T make it an ideal tool in establishing imaging biomarkers for MND (De Vries et al, 2024). The integration of 7T imaging technology and of new imaging biomarkers into the current diagnostic pathway for patients with MND would provide distinct advantages over conventional imaging. Identification of microstructural degenerative changes in the motor cortex of patients with this disorder early in the disease process would increase diagnostic certainty. This is particularly important in a disorder such as MND, which has devastating consequences, yet has no definite diagnostic test or specific biomarker. As more expensive biological therapies come into play in treating MND, identifying response by measuring stabilisation of the motor cortex structural integrity will be important. The detailed structural imaging provided by 7T MRI, combined with genetic information, will drive the development of precision medicine in these individuals.
There has been much interest in potential biomarkers, including imaging biomarkers, in MND over the recent years. We propose taking this further by establishing an array of specific imaging biomarkers for subtypes of MND, and by developing a tailored diagnostic "Biomarker MND Imaging Protocol" for patients, optimised to benefit from the strength of 7T. This would not only help diagnosis of patients suffering from MND but would allow stratification for treatment purposes and monitoring of the effect of possible new treatments.
7T MRI, compared to lower field strength, offers, increased signal-to-noise-ratio, allowing for the acquisition of higher resolution images, greater sensitivity to differences in susceptibility effects, and increased spectral resolution (Schick et al, 2005). These intrinsic properties of 7T make it an ideal tool in establishing imaging biomarkers for MND. The integration of 7T imaging technology and of new imaging biomarkers into the current diagnostic pathway for patients with MND would provide distinct advantages over conventional imaging. Identification of microstructural degenerative changes in the motor cortex of patients with this disorder early in the disease process would increase diagnostic certainty. This is particularly important in a disorder such as MND, which has devastating consequences, yet has no definite diagnostic test or specific biomarker. As more expensive biological therapies come into play in treating MND, identifying response by measuring stabilisation of the motor cortex structural integrity will be important. The detailed structural imaging provided by 7T MRI, combined with genetic information, will drive the development of precision medicine in these individuals.
There is interest in potential biomarkers, including imaging biomarkers, in MND over the recent years. We propose taking this further by establishing an array of specific imaging biomarkers for subtypes of MND, and by developing a tailored diagnostic "Biomarker MND Imaging Protocol" for patients, optimised to benefit from the strength of 7T. This would not only help diagnosis of patients suffering from MND, but would allow stratification for treatment purposes and monitoring of the effect of possible new treatments.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Coil | – | Device: MRIALS cases |
| Head and Neck coil | – | Device: MRIALS cases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with MND, including subtypes Amyotrophic Lateral Sclerosis (ALS), Primary Lateral Sclerosis (PLS), Progressive Muscular Atrophy (PMA), Progressive Bulbar Palsy (PBP) will be included in the study. Target number of subjects is 30, split into two groups of 15 (scanned on two different coils with different anatomical cover of brainstem and upper cord). These patients will be identified by their clinical Neurology and MND team.
Key inclusion criteria (3 listed)
- Male or non-pregnant female patients, ≥18 years of age
- Able to give informed consent
- Patients diagnosed as definite or probable motor neuron disease (El Escorial Criteria)
Key exclusion criteria (11 listed)
- Contraindications to 7T MRI;
- active implants,
- tattoos in head and neck area
- post-surgical brain implants and metal ware
- Pregnancy
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 |
|---|---|---|
| MRISpecialist 7 T head and neck coil and standard 7T Head coil will be evaluated at identifying biomarkers for ALS. | Device | Head and Neck coil, Standard Coil |
Primary outcome
Demonstration of Pathology on 7T MRI
Time frame: 2 years
Demonstration of MND pathology on 7T MRI by the identification of atrophy of motor cortex by measurement of the thickness of the motor cortex in mm.
2 secondary outcomes
Tolerability of 7 T scanning by ALS patients.
Time frame: 2 years
Quality of MRI imaging of ALS patients by 7T system.
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: Yes. Tabulated results for biomarkers will be made available.
Related trials for ALS - Amyotrophic Lateral Sclerosis
RecruitingPhase 1/2
Study is to Assess the Safety and Tolerability of VTx-002 in Participants With ALS
Amyotrophic Lateral Sclerosis
Not yet recruiting
A Study on the Addition of Alsum30 for the Treatment of Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis (ALS), Bacillus Coagulans
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Not yet recruitingPhase 1
Safety, Tolerability, and Pharmacodynamic Exploration of Orelabrutinib in Patients With Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic Lateral Sclerosis (ALS)
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ALS - Amyotrophic Lateral Sclerosis, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
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 3 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 14 Sep 2026. 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 Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact George H Gorrie, MA. MB.ChB. Ph.D FRCP (Ed) (01412327542, george.gorrie2@nhs.scot), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstration of Pathology on 7T MRI (time frame: 2 years). 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 14 Sep 2026.