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NCT Number: NCT06043518

CNS Changes Following Upper Limb Loss

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.

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Key information

Conditions

Amputation, Congenital Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Ectromelia Limb Deformities, Congenital Musculoskeletal Abnormalities Musculoskeletal Diseases Upper Limb; Amelia

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

  1. Conventional magnetic resonance imaging (MRI) parameter

    Time frame: 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

  2. Amputees: Motor Activity Log questionnaire

    Time frame: Up to 50 weeks

    Evaluation of residual limb and/or prosthesis usage as compared to other body parts via a questionnaire and behavioural assessments.

Study contacts

Contact information is provided by the study sponsor or research team.

Paige Howell, PhD

CONTACT

[email protected]

+41 44 632 32 94

Sanne Kikkert

CONTACT

[email protected]

+41 44 632 32 94

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • ETH Zurich

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Sep 21, 2023
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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