Amputation, CongenitalNCT06043518
CNS Changes Following Upper Limb Loss
An observational study of Amputation, Congenital and Upper Limb; Amelia, run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Amputation, Congenital, Upper Limb; Amelia
- What is being tested?
- MRI
- How many people
- 70 participants
- Where
- 1 siteSwitzerland
- Study dates
- 5 Jul 2023to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with an upper-limb amputation and healthy subjects.
Who may be able to join
- Age 18-75
- Upper-limb congenital amputees with complete absence of a hand
- Signed informed consent
- Age 18-75
- Signed Informed consent
Who cannot join
- Contraindications to magnetic resonance imaging
- Neurological impairment of body function impairments not induced by spinal cord injury
- BMI > 40
- Pregnancy
- Claustrophobia
- Contraindications to magnetic resonance imaging
Show all 11Show fewer
- Pregnancy
- Neurological illness
- Impairment of body function induced by a congenital upper-limb amputation
- Claustrophobia
- BMI > 40
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Balgrist Campus
Zurich, Canton of Zurich, 8008
Paige Howell, PhD, +41 44 632 32 94, paige.howell@hest.ethz.ch
About this study
Official title: Functional, Structural, and Metabolic Central Nervous System Changes Following Damage of the Central Nervous System
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.
- Conditions
- Amputation, Congenital, Upper Limb; Amelia
- Being tested
- MRI
- Keywords
- Plasticity, Congenital amputee, Upper limb amelia, Somatotopy, Functional MRI, Hand, Reorganisation
- Medical subject headings
- Amputation, Congenital, Ectromelia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic 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
MRIDiagnostic test
Use of functional and structural MRI in both the brain and the spinal cord and questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| Patients with congenital amputation | Not described Receives: Diagnostic Test: MRI | |
| Healthy subjects | Not described Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 50 weeks
Secondary outcomes (2)
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
Measured: Up to 50 weeks
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.
Measured: Up to 50 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start5 Jul 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amputation, CongenitalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- ETH Zurich
- Responsible party
- Sponsor
- Investigators
- Patrick Freund, Prof., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06043518
- Sponsor's protocol ID
- 2018-00937 - Upper Limb Loss
- Other IDs
- 2018
- Status last verified
- Oct 2025
- First submitted
- 12 Sep 2023
- Last updated
- 19 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional, Structural, and Metabolic Central Nervous System Changes Following Damage of the Central Nervous System
- ClinicalTrials.gov ID
- NCT06043518
- Acronym / sponsor ID
- 2018-00937 - Upper Limb Loss
- Conditions
- Amputation, Congenital, Upper Limb; Amelia
- Keywords
- Plasticity, Congenital amputee, Upper limb amelia, Somatotopy, Functional MRI, Hand, Reorganisation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- ETH Zurich
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with congenital amputation | – | Diagnostic Test: MRI |
| Healthy subjects | – | Diagnostic Test: MRI |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an upper-limb amputation and healthy subjects.
Key inclusion criteria (5 listed)
- Age 18-75
- Upper-limb congenital amputees with complete absence of a hand
- Signed informed consent
- Age 18-75
- Signed Informed consent
Key exclusion criteria (11 listed)
- Contraindications to magnetic resonance imaging
- Neurological impairment of body function impairments not induced by spinal cord injury
- BMI > 40
- Pregnancy
- Claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIUse of functional and structural MRI in both the brain and the spinal cord as well as questionnaires and clinical measures of motor function | Diagnostic test | Patients with congenital amputation |
| MRIUse of functional and structural MRI in both the brain and the spinal cord and questionnaires. | Diagnostic test | Healthy subjects |
Primary outcome
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
2 secondary outcomes
Conventional magnetic resonance imaging (MRI) parameter
Time frame: Up to 50 weeks
Amputees: Motor Activity Log questionnaire
Time frame: Up to 50 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patrick Freund, Prof. principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amputation, Congenital and Upper Limb; Amelia, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paige Howell, PhD (+41 44 632 32 94, paige.howell@hest.ethz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of functional MRI (fMRI) parameter between 2 to 4 time points (time frame: Up to 50 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.