CNS Changes Following Upper Limb Loss
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MRI, MRI.
- Who it may be relevant to
- Registry conditions: Amputation, Congenital, Upper Limb; Amelia. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Functional, Structural, and Metabolic Central Nervous System Changes Following Damage of the Central Nervous System
Overview
The objective of this study is to better understand the structural and functional changes that the central nervous system (CNS) undergoes following congenital upper limb loss. The focus is on the brain's sensory processing and how neuronal changes may relate to clinical measures. By doing so, the hope is to gain insight into the contribution of critical periods to the plasticity of the sensorimotor processing stream. Both macroscopic and microscopic changes of the brain will be examined in individuals with upper limb amelia and compared to healthy controls. fMRI will be combined with behavioural testing to understand which clinical and behavioural determinants drive somatosensory representations along the entire somatosensory processing stream. Using advanced imaging techniques, the aim is to investigate the contribution of brainstem reorganisation to plasticity observed at the cortical level and, by doing so, gain a better understanding of the mechanistic underpinnings of functional reorganisation. Overall, the hope is to provide the first mechanistic insight into whether early life experiences are crucial for the development of the relay nuclei in the central nervous system and how these changes relate to clinical measures such as adaptive behaviours or pain.
Interventions
- Diagnostic test MRI
Use of functional and structural MRI in both the brain and the spinal cord as well as questionnaires and clinical measures of motor function - Diagnostic test MRI
Use of functional and structural MRI in both the brain and the spinal cord and questionnaires.
Primary outcome measures
- Change of functional MRI (fMRI) parameter between 2 to 4 time points [Time frame: Up to 50 weeks]
Secondary outcome measures (2)
- Conventional magnetic resonance imaging (MRI) parameter [Time frame: Up to 50 weeks]
- Amputees: Motor Activity Log questionnaire [Time frame: Up to 50 weeks]
Eligibility criteria
Inclusion Criteria - Patients:
- Age 18-75
- Upper-limb congenital amputees with complete absence of a hand
- Signed informed consent
Exclusion Criteria - Patients:
- Contraindications to magnetic resonance imaging
- Neurological impairment of body function impairments not induced by spinal cord injury
- BMI > 40
- Pregnancy
- Claustrophobia
Inclusion Criteria - Healthy subjects:
- Age 18-75
- Signed Informed consent
Exclusion Criteria - Healthy subjects:
- Contraindications to magnetic resonance imaging
- Pregnancy
- Neurological illness
- Impairment of body function induced by a congenital upper-limb amputation
- Claustrophobia
- BMI > 40
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Switzerland · 1 center
- Balgrist Campus — Zurich
Identifiers
NCT: NCT06043518 · 2018-00937 - Upper Limb Loss