CNS Changes Following Amputation

Recruiting

• Conditions: Amputation, Congenital; Upper Limb; Amelia
• Interventions: Diagnostic Test: MRI

• Registration Number: NCT06043518
• Lead Sponsor: University of Zurich

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-05
• Study First Submitted: 2023-09-12
• Study First Submitted QC: 2023-09-12
• Study First Posted: 2023-09-21
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-25
• Primary Completion: 2027-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with congenital amputation	MRI	-
Healthy subjects	MRI	-

Primary Outcome Measures

Name	Time	Method
Change of functional MRI (fMRI) parameter between 2 to 4 time points	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 Outcome Measures

Name	Time	Method
Conventional magnetic resonance imaging (MRI) parameter	Up to 50 weeks	Structural characteristics in the brain and cervical spinal cord are assessed in patients with congenital upper-limb amputations using conventional MRI and compared to healthy controls
Amputees: Motor Activity Log questionnaire	Up to 50 weeks	Evaluation of residual limb and/or prosthesis usage as compared to other body parts via a questionnaire and behavioural assessments.

Trial Locations

Locations (1)

Balgrist Campus; 🇨🇭 Zurich, Switzerland