Clinical trial NCT06075056: Neuro-navigated TMS for Chronic SCI Patients
Official title: Neuro-navigated TMS for Chronic SCI Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spinal Cord Injuries
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
Collaborators: name: King's College London
First posted: 2023-10-10
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 20 patients, 10 Cervical SCI and 10 Thoracic SCI who meet eligibility criteria

Brief summary: Can neuro-navigated Transcranial Magnetic Stimulation be used as an additional outcome measure to EM-SCI assessments in a Spinal cord injury trial?

* Compare EM-SCI assessment with nTMS in ten chronic thoracic SCI patients
* Compare EM-SCI assessment with nTMS in ten chronic cervical SCI patients

Detailed description: This is an exciting time for translating experimental Advanced Therapies into treatments for spinal cord injury (SCI). There are currently no regenerative therapies available that target the underlying biology. Over the last 5 years the investigating team have developed a viable gene therapy approach for treating SCI in pre-clinical models. The investigators are on the cusp of translating this therapy to first-in-human studies and are leading a programme to establish a world-first regenerative gene therapy for traumatic SCI affecting upper limb mobility (since recovery of arm/hand function is one of the highest patient priorities). The team will develop an innovative trial design involving neurosurgical delivery of the gene therapy into the spinal cord, followed by specialist neurorehabilitation.

For a clinical trial to have the best chance of success, one of the key steps needed to be addressed include validation of new assessment methods for the clinical trial. Our aim is to determine whether neuro-navigated Transcranial Magnetic Stimulation (nTMS) can be used as an adjunct to standard assessments of function in SCI patients. Following two patient and public involvement events (patient focus group and feedback for project design with our rehabilitation partners), the investigating team will recruit chronic SCI subjects to carry out European Multicenter Study about SCI (EM-SCI) assessments. EM-SCI assessments are well established assessment tools for SCI patients and include the EM-SCI 'core' assessments (ISNCSCI, WISCI-III, Walk Test, SCIM 3) and EM-SCI 'additional' assessments (GRASSP, Pain score, neurophysiology). Following this investigators will compare and validate nTMS with EM-SCI assessments in stable chronic SCI patients with both cervical and thoracic injuries. nTMS with combined Tractography MRI of the cortico-spinal tract (the main motor pathway of the spinal cord) will allow functional characterisation and density measurements of this tract in SCI patients.

Eligibility criteria: Inclusion Criteria:

* Single traumatic event at least 6 months prior to recruitment
* ISNCSCI grade A, B, C or D
* Able to participate in EM-SCI and nTMS assessments and capable of informed consent

Exclusion Criteria:

* History of Malignancy
* History of other Neurological disease
* Pregnancy
* Other cord lesions or tethering
* Cord transaction or penetrating injury

Primary outcomes:
measure: Resting Motor Threshold (rMT)
timeFrame: 1 year
measure: Motor Evoked Potential (MEP) Latency
timeFrame: 1 year
measure: Motor Evoked Potential (MEP) amplitude
timeFrame: 1 year
measure: Spinal cord independence measure III (SCIM III)
timeFrame: 1 year
measure: Graded redefined assessment of strength, sensation and prehension (GRASSP)
timeFrame: 1 year
measure: Diffusion Tension Imaging Metrics of Corticospinal Tract Tractography
timeFrame: 1 year
measure: Cortical Motor Area and Volume
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College Hospital
Study officials:
affiliation: King's College London
name: Aminul Ahmed
role: PRINCIPAL_INVESTIGATOR
References: