Validating neuro-navigated TMS stimulation in SCI patients
Research type
Research Study
Full title
Validating neuro-navigated TMS stimulation in Chronic SCI patients: a feasibility study towards a gene therapy for SCI.
IRAS ID
320531
Contact name
Aminul Ahmed
Contact email
Sponsor organisation
King's College London
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 6 months, 31 days
Research summary
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 we have developed a viable gene therapy approach for treating SCI in pre-clinical models. We are on the cusp of translating this therapy to first-in-human studies. We 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). Our team will develop an innovative trial design involving neurosurgical delivery of the gene therapy into the spinal cord, followed by specialist neurorehabilitation. \n\nFor a clinical trial to have the best chance of success, we need to address key steps which 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), we 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). We 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.
REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
23/NW/0116
Date of REC Opinion
26 May 2023
REC opinion
Further Information Favourable Opinion