Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:05 PM
Ignite Modification Date:
2025-12-24 @ 4:05 PM
NCT ID:
NCT05242666
Eligibility Criteria:
Inclusion Criteria
1. Participant has a diagnosis of DCM, based on a combination of symptoms, signs and conventional MRI findings (Table 2)
2. Participant is scheduled for surgical treatment for DCM
3. Participant is willing and able to give informed consent for participation in the study;
4. Male or Female, aged 18 - 85 years (inclusive);
Exclusion Criteria
The participant may not enter the study if ANY of the following apply:
1. Participant unable to give informed consent;
2. Participant unable to undergo, or intolerant of MR or PET/MR imaging
3. Participant has co-existing or prior neurological disease of the brain, spinal cord, or peripheral nervous system, including but not limited to, Lumbar Canal Stenosis, Multiple Sclerosis, Dementia and Parkinson's Disease.
4. Contraindications to MRI: These are chiefly the presence of metallic implants that are not known to be MR safe, particularly in terms of movement or substantial heating. Devices that may need to be considered in this context include (this is not an exhaustive list, and this issue will be considered on a case-by-case basis for any implant or external fixation device):
* Cerebral aneurysm clips not known to be MR safe
* Intra-ocular metallic shards
* Cochlear implants
* Automatic cardioverter defibrillators
* Nerve stimulation units
* Other electronic implants, such as cardiac pacemakers
* Orthopedic external fixations
Exclusion Criteria Specific for PET/MR Imaging Stream
In addition, the following exclusion criteria will apply for PET imaging, to reduce implications of exposure to ionising radiation, or interpretation of findings.
1. Female patients who are pregnant or breast-feeding
2. Participants whose DCM surgery will include the insertion of metallic implants to secure multiple levels of the spine (technically termed 'instrumentation')
3. Age \<40
4.3.2 Volunteers
Inclusion Criteria
1. Participant is willing and able to give informed consent for participation in the study;
2. Male or Female, aged 18 - 85 years (inclusive); Exclusion Criteria
The participant may not enter the study if ANY of the following apply:
1. Participant unable to give informed consent;
2. Participant unable to undergo, or intolerant of MR imaging
3. Participant has co-existing or prior neurological disease of the brain, spinal cord, or peripheral nervous system, including but not limited to, Lumbar Canal Stenosis, Multiple Sclerosis, Dementia and Parkinson's Disease.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05242666
Study Brief:
Protocol Section:
NCT05242666