CNS Changes Following Amputation

Amputation, Congenital Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06043518
• Other study ID #: 2018-00937 - Amputees
• Status: Recruiting
• Start date: July 5, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: September 2023
• Source: University of Zurich
• Contact: Paige Howell, PhD
• Phone: +41 44 510 72 08
• Email: paige.howell[@]hest.ethz.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Amputation, Congenital

Intervention

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

Locations

Country	Name	City	State
Switzerland	Balgrist Campus	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	ETH Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of functional MRI (fMRI) parameter between 2 to 4 time points	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	Up to 50 weeks
Secondary	Conventional magnetic resonance imaging (MRI) parameter	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	Up to 50 weeks
Secondary	Amputees: Motor Activity Log questionnaire	Evaluation of residual limb and/or prosthesis usage as compared to other body parts via a questionnaire and behavioural assessments.	Up to 50 weeks