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Clinical Trials/NCT06043518
NCT06043518
Recruiting
Not Applicable

Functional, Structural, and Metabolic Central Nervous System Changes Following Damage of the Central Nervous System

University of Zurich1 site in 1 country70 target enrollmentJuly 5, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Amputation, Congenital
Sponsor
University of Zurich
Enrollment
70
Locations
1
Primary Endpoint
Change of functional MRI (fMRI) parameter between 2 to 4 time points
Status
Recruiting
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 5, 2023
End Date
June 30, 2027
Last Updated
5 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change of functional MRI (fMRI) parameter between 2 to 4 time points

Time Frame: Up to 50 weeks

Change of brain activities is assessed between 2 to 4 time points using fMRI during resting-state or a specific task in patients with congenital amputations and compared to healthy controls

Secondary Outcomes

  • Conventional magnetic resonance imaging (MRI) parameter(Up to 50 weeks)
  • Amputees: Motor Activity Log questionnaire(Up to 50 weeks)

Study Sites (1)

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