7T Imaging Pilot-study in Patients With Motor Neuron Disease to Find Non-Invasive Disease Imaging Biomarkers

NCT07818772 | Recruiting

• 2 other identifiers: NorthGlasgowUMN5DF/CAAu23/100025
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

ALS - Amyotrophic Lateral Sclerosis

Keywords

7 Tesla MRI; ALS; Biomarkers

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (2)

• Tolerability of 7 T scanning by ALS patients.

  2 years

• Quality of MRI imaging of ALS patients by 7T system.

  2 years

Study Arms (2)

Standard Coil

ALS cases

Device: MRI

Head and Neck coil

ALS cases

Device: MRI

Interventions

MRI DEVICE

Specialist 7 T head and neck coil and standard 7T Head coil will be evaluated at identifying biomarkers for ALS.

Head and Neck coil; Standard Coil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• NHS Greater Glasgow and Clyde Board HQ: collaborator

Study Sites (1)

ICE Building

Glasgow, G514TF, United Kingdom

RECRUITING

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

George H Gorrie, MA. MB.ChB. Ph.D FRCP (Ed)

CONTACT

01412327542; george.gorrie2@nhs.scot

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: September 14, 2026
• Study Start: April 13, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: September 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Publication date to ten years post publication.
• Access Criteria: Researchers who have academic credentials and who provide a valid reason for wishing to examine the data.

Locations

GB (1)