Functional and Structural Changes in the Central Nervous System Following Spinal Cord Injury

NCT ID: NCT05681936

Last Updated: 2025-12-15

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

225 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2027-08-31

Brief Summary

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Building on recent improvements, state-of-the-art functional MRI will be applied as an advanced diagnostic tool for the lumbosacral cord in spinal cord injury (SCI) patients to characterize the remaining neuronal activity of the motor and sensory neurons. Alterations in the activity pattern will reveal the effect upon task-related spinal cord activity of the lower motor neurons and sensory neurons undergoing trauma-induced neurodegeneration, at a spatial specificity that has not been possible so far. Results of this study will be of crucial importance because SCI patients can only profit from regeneration-inducing therapies if spinal neuronal function is preserved below the level of lesion.

Detailed Description

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Conditions

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Spinal Cord Injuries Neurogenic Bladder Dysfunction Degenerative Cervical Spinal Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cross-sectional study: healthy controls

No interventions assigned to this group

Cross-sectional study: chronic traumatic SCI patients

No interventions assigned to this group

Cross-sectional study: non-traumatic SCI patients with degenerative spondylotic myelopathy

No interventions assigned to this group

Longitudinal study: healthy controls

No interventions assigned to this group

Longitudinal study: acute traumatic SCI patients (< 2 months after SCI)

No interventions assigned to this group

Longitudinal study: patients with neurogenic lower urinary tract dysfunction

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years
* Informed consent
* Willing to take part and follow requirements of the protocol


Cross-sectional study:

* Chronic traumatic SCI (\> 12 months after injury) or
* Diagnosed degenerative spondylotic myelopathy (DCM)

Longitudinal study:

* Acute traumatic SCI (\< 2 months after injury) or
* Patients with neurogenic lower urinary tract dysfunction (NLUTD) who undergo routine tibial nerve stimulation (TNS) treatment as part of their rehabilitation (but independently of this study) at Balgrist University Hospital

Exclusion Criteria

* Age \< 18 years
* Contraindications for MRI (presence of pacemaker or other type of stimulator in the body, presence of metallic foreign body in or on the body, etc.); we will comply with the imaging center's (SCMI) guidelines and in case of doubt we will exclude the participant from the study
* No informed consent
* History of psychiatric or neurological disease, apart from those induced by SCI (e.g.epilepsy)
* History of skull opening or head trauma
* Known or suspected non-adherence, drug or alcohol abuse
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
* Women who are pregnant (when uncertain, participants will undergo urine testing) or breastfeeding
* Intention to become pregnant during the course of the study
* Body mass index (BMI) \> 35
* Individuals especially in need of protection (according to Research with Human Subjects published by the Swiss Academy of Medical Sciences)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Swiss National Science Foundation

OTHER

Sponsor Role collaborator

Swiss Paraplegic Research, Nottwil

NETWORK

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. Dr. med. Dr. rer. nat.

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

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Balgrist University Hospital

Zurich, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Gergely David, Dr.

Role: CONTACT

+41 44 510 72 13

Christian Kuendig, MSc

Role: CONTACT

+41 44 510 72 08

Facility Contacts

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Gergely David, Dr.

Role: primary

+41 44 510 72 13

Christian Kuendig, MSc

Role: backup

+41 44 510 72 08

Other Identifiers

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2022-00558

Identifier Type: -

Identifier Source: org_study_id

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