CNS Changes Following Upper Limb Loss

NCT ID: NCT06043518

Last Updated: 2025-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-05

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Amputation, Congenital Upper Limb; Amelia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with congenital amputation

MRI

Intervention Type 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

Healthy subjects

MRI

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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MRI

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

Intervention Type DIAGNOSTIC_TEST

MRI

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Age 18-75
* Upper-limb congenital amputees with complete absence of a hand
* Signed informed consent


* Age 18-75
* Signed Informed consent

Exclusion Criteria

* 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
* Pregnancy
* Neurological illness
* Impairment of body function induced by a congenital upper-limb amputation
* Claustrophobia
* BMI \> 40
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ETH Zurich

OTHER

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patrick Freund, Prof.

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

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Balgrist Campus

Zurich, Canton of Zurich, Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Paige Howell, PhD

Role: CONTACT

+41 44 632 32 94

Sanne Kikkert

Role: CONTACT

+41 44 632 32 94

Facility Contacts

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Paige Howell, PhD

Role: primary

+41 44 632 32 94

Other Identifiers

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2018-00937 - Upper Limb Loss

Identifier Type: -

Identifier Source: org_study_id

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