CNS Changes Following Upper Limb Loss

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorUniversity of Zurich

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Age 18-75

Upper-limb congenital amputees with complete absence of a hand

Signed informed consent

Disqualifiers

Contraindications to magnetic resonance imaging

Neurological impairment of body function impairments not induced by spinal cord injury

BMI > 40

Pregnancy

Trial population

Patients with an upper-limb amputation and healthy subjects.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • MRI

    Diagnostic test

    Use of functional and structural MRI in both the brain and the spinal cord as well as questionnaires and clinical measures of motor function

  • MRI

    Diagnostic test

    Use of functional and structural MRI in both the brain and the spinal cord and questionnaires.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Patients with congenital amputation1 intervention
Group B: Healthy subjects1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Up to 50 weeks

Secondary outcomes

1

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

Time frame
Up to 50 weeks
2

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.

Time frame
Up to 50 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Zurich

Lead sponsor

ETH Zurich

Collaborator