Clinical trial NCT06043518: CNS Changes Following Amputation
Official title: Functional, Structural, and Metabolic Central Nervous System Changes Following Damage of the Central Nervous System
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Amputation, Congenital
Upper Limb; Amelia
Keywords: Plasticity
Congenital amputee
Upper limb amelia
Somatotopy
Functional MRI
Hand
Reorganisation
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: ETH Zurich
First posted: 2023-09-21
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with an upper-limb amputation and healthy subjects.

Brief summary: 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.


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

Primary outcomes:
measure: Change of functional MRI (fMRI) parameter between 2 to 4 time points
timeFrame: Up to 50 weeks
Secondary outcomes:
measure: Conventional magnetic resonance imaging (MRI) parameter
timeFrame: Up to 50 weeks
measure: Amputees: Motor Activity Log questionnaire
timeFrame: Up to 50 weeks
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Balgrist Campus
Study officials:
affiliation: University of Zurich
name: Patrick Freund, Prof.
role: PRINCIPAL_INVESTIGATOR
References: