Spinal Cord InjuriesNCT06075056
Neuro-navigated TMS for Chronic SCI Patients
An observational study of Spinal Cord Injuries, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spinal Cord Injuries
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2023to 1 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: 20 patients, 10 Cervical SCI and 10 Thoracic SCI who meet eligibility criteria
Who may be able to join
- 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
Who cannot join
- History of Malignancy
- History of other Neurological disease
- Pregnancy
- Other cord lesions or tethering
- Cord transaction or penetrating injury
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
King's College Hospital
London, SE5 9RS
Aminul Ahmed, PhD
Azharul Khan, BSc, PgDip
About this study
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
Read the 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.
- Conditions
- Spinal Cord Injuries
- Being tested
- No Intervention
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
No intervention is planned as part of this study, this is a feasibility/pilot study
| Study group | Role | What they receive |
|---|---|---|
| Chronic spinal cord injuries | Defined as spinal cord injuries secondary to a single traumatic event to the Cervical or thoracic spine, more than 6 months ago. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting Motor Threshold (rMT)
Resting motor threshold (rMT) is the amount of machine output responsible for a positive motor evoked potential in at least % of the trials. This outcome is expressed in % and it is directly obtained from the TMS software.
Measured: 1 year
Motor Evoked Potential (MEP) Latency
MEP latency is a TMS measure of time taken for intracortical processing, spinal processing and neurmuscular transmission. It is measure in miliseconds (mS). Linear regression analysis will be used to compare TMS measurements against EM-SCI measurements to validate TMS as an assessment tool for chronic SCI.
Measured: 1 year
Motor Evoked Potential (MEP) amplitude
Motor evoked potential (MEP) Amplitude is a TMS measurement of the number of motoneurons recruited during TMS stimulation. It is expressed in milivolt (mV). Linear regression analysis will be used to compare TMS measurements against EM-SCI measurements to validate TMS as an assessment tool for chronic SCI.
Measured: 1 year
Spinal cord independence measure III (SCIM III)
SCIM is a validated reproducible measure used in EM-SCI, as a measure of spinal cord injury functionality. This is a questionnaire with a score from 0-100.
Measured: 1 year
Graded redefined assessment of strength, sensation and prehension (GRASSP)
GRASSP is a validated clinical impairment score to measure impairment in the upper limbs. This is a tool currently used within the EM-SCI protocol.
Measured: 1 year
Diffusion Tension Imaging Metrics of Corticospinal Tract Tractography
We will calculate the fractional anisotropy, radial diffusivity, axial diffusivity and mean diffusivity for bilateral cortical spinal tract. These metrics range from 0 to 1. We will use DSI Studio Software to proceed with these calculations.
Measured: 1 year
Cortical Motor Area and Volume
We will calculate the area and volume of cortical activation of both upper and lower limbs.The area is calculated in cm2 and the volume in microvolt per cm2. We will use TMSMap Software to produce these metrics.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 Jul 2023
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
- Investigators
- Aminul Ahmed, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06075056
- Sponsor's protocol ID
- King's College Hospital
- Status last verified
- Oct 2023
- First submitted
- 3 Jan 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuro-navigated TMS for Chronic SCI Patients
- ClinicalTrials.gov ID
- NCT06075056
- Acronym / sponsor ID
- King's College Hospital
- Conditions
- Spinal Cord Injuries
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic spinal cord injuries | – | Other: No InterventionDefined as spinal cord injuries secondary to a single traumatic event to the Cervical or thoracic spine, more than 6 months ago. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- 20 patients, 10 Cervical SCI and 10 Thoracic SCI who meet eligibility criteria
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- History of Malignancy
- History of other Neurological disease
- Pregnancy
- Other cord lesions or tethering
- Cord transaction or penetrating injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionNo intervention is planned as part of this study, this is a feasibility/pilot study | Other | Chronic spinal cord injuries |
Primary outcome
Resting Motor Threshold (rMT)
Time frame: 1 year
Resting motor threshold (rMT) is the amount of machine output responsible for a positive motor evoked potential in at least % of the trials. This outcome is expressed in % and it is directly obtained from the TMS software.
Motor Evoked Potential (MEP) Latency
Time frame: 1 year
MEP latency is a TMS measure of time taken for intracortical processing, spinal processing and neurmuscular transmission. It is measure in miliseconds (mS). Linear regression analysis will be used to compare TMS measurements against EM-SCI measurements to validate TMS as an assessment tool for chronic SCI.
Motor Evoked Potential (MEP) amplitude
Time frame: 1 year
Motor evoked potential (MEP) Amplitude is a TMS measurement of the number of motoneurons recruited during TMS stimulation. It is expressed in milivolt (mV). Linear regression analysis will be used to compare TMS measurements against EM-SCI measurements to validate TMS as an assessment tool for chronic SCI.
Spinal cord independence measure III (SCIM III)
Time frame: 1 year
SCIM is a validated reproducible measure used in EM-SCI, as a measure of spinal cord injury functionality. This is a questionnaire with a score from 0-100.
Graded redefined assessment of strength, sensation and prehension (GRASSP)
Time frame: 1 year
GRASSP is a validated clinical impairment score to measure impairment in the upper limbs. This is a tool currently used within the EM-SCI protocol.
Diffusion Tension Imaging Metrics of Corticospinal Tract Tractography
Time frame: 1 year
We will calculate the fractional anisotropy, radial diffusivity, axial diffusivity and mean diffusivity for bilateral cortical spinal tract. These metrics range from 0 to 1. We will use DSI Studio Software to proceed with these calculations.
Cortical Motor Area and Volume
Time frame: 1 year
We will calculate the area and volume of cortical activation of both upper and lower limbs.The area is calculated in cm2 and the volume in microvolt per cm2. We will use TMSMap Software to produce these metrics.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aminul Ahmed principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Azharul Khan (07932554463, azharul.khan@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting Motor Threshold (rMT) (time frame: 1 year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.