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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNHS Greater Glasgow and Clyde

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Contraindications to 7T MRI;

active implants,

tattoos in head and neck area

post-surgical brain implants and metal ware

Trial 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.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • MRI

    Device

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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Standard Coil1 intervention
Group B: Head and Neck coil1 intervention

Trial outcomes

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.

Time frame
2 years

Secondary outcomes

1

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.

Time frame
2 years
2

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.

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NHS Greater Glasgow and Clyde

Lead sponsor

NHS Greater Glasgow and Clyde Board HQ

Collaborator