- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT06043518
CNS-endringer etter amputasjon
Funksjonelle, strukturelle og metabolske endringer i sentralnervesystemet etter skade på sentralnervesystemet
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Paige Howell, PhD
- Telefonnummer: +41 44 632 32 94
- E-post: paige.howell@hest.ethz.ch
Studer Kontakt Backup
- Navn: Sanne Kikkert
- Telefonnummer: +41 44 632 32 94
- E-post: sanne.kikkert@balgrist.ch
Studiesteder
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-
Canton of Zurich
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Zurich, Canton of Zurich, Sveits, 8008
- Rekruttering
- Balgrist Campus
-
Ta kontakt med:
- Paige Howell, PhD
- Telefonnummer: +41 44 632 32 94
- E-post: paige.howell@hest.ethz.ch
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Patients with an upper-limb amputation and healthy subjects.
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: CASE_CONTROL
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Sunne fag
|
Use of functional and structural MRI in both the brain and the spinal cord as well as questionnaires and clinical measures of motor function Use of functional and structural MRI in both the brain and the spinal cord and questionnaires. |
|
Pasienter med medfødt amputasjon
|
Use of functional and structural MRI in both the brain and the spinal cord as well as questionnaires and clinical measures of motor function Use of functional and structural MRI in both the brain and the spinal cord and questionnaires. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change of functional MRI (fMRI) parameter between 2 to 4 time points
Tidsramme: 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 |
Up to 50 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Conventional magnetic resonance imaging (MRI) parameter
Tidsramme: 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 |
Up to 50 weeks
|
|
Amputees: Motor Activity Log questionnaire
Tidsramme: Up to 50 weeks
|
Evaluation of residual limb and/or prosthesis usage as compared to other body parts via a questionnaire and behavioural assessments. |
Up to 50 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Patrick Freund, Prof., University of Zurich
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2018-00937 - Upper Limb Loss
- 2018 (U.S. NIH-stipend/kontrakt)
Legemiddel- og utstyrsinformasjon, studiedokumenter
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