| NCT ID | NCT06043518 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Zurich |
| Condition | Amputation, Congenital |
| Study Type | OBSERVATIONAL |
| Enrollment | 70 participants |
| Start Date | 2023-07-05 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 70 participants in total. It began in 2023-07-05 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Patrick Freund, Prof.
PRINCIPAL INVESTIGATOR
University of Zurich
Frequently Asked Questions
Who can join the NCT06043518 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Amputation, Congenital. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06043518 currently recruiting?
Yes, NCT06043518 is actively recruiting participants. Contact the research team at paige.howell@hest.ethz.ch for enrollment information.
Where is the NCT06043518 trial being conducted?
This trial is being conducted at Zurich, Switzerland.
Who is sponsoring the NCT06043518 clinical trial?
NCT06043518 is sponsored by University of Zurich. The principal investigator is Patrick Freund, Prof. at University of Zurich. The trial plans to enroll 70 participants.