CNS Changes Following Amputation

Sponsor

University of Zurich (Other)

Overall Status

Recruiting

CT.gov ID

NCT06043518

Collaborator

ETH Zurich (Other)

Enrollment

Location

35.8

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Amputation, Congenital Upper Limb; Amelia	Diagnostic Test: MRI Diagnostic Test: MRI

Study Design

Study Type:

Observational

Anticipated Enrollment :

70 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 5, 2023

Anticipated Primary Completion Date :

Jun 30, 2026

Anticipated Study Completion Date :

Jun 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Patients with congenital amputation	Diagnostic Test: MRI We will examine patients with congenital upper-limb amputations using functional and structural MRI in both the brain and the spinal cord as well as questionnaires and clinical measures of motor function
Healthy subjects	Diagnostic Test: MRI We will examine healthy patients using functional and structural MRI in both the brain and the spinal cord and questionnaires.

Arm

Intervention/Treatment

Patients with congenital amputation

Diagnostic Test: MRI

We will examine patients with congenital upper-limb amputations using functional and structural MRI in both the brain and the spinal cord as well as questionnaires and clinical measures of motor function

Healthy subjects

Diagnostic Test: MRI

We will examine healthy patients using functional and structural MRI in both the brain and the spinal cord and questionnaires.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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