NCT06075056

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

7 months

First QC Date

January 3, 2023

Last Update Submit

October 3, 2023

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (7)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    1 year

Study Arms (1)

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.

Other: No Intervention

Interventions

No InterventionOTHER

No intervention is planned as part of this study, this is a feasibility/pilot study

Chronic spinal cord injuries

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

20 patients, 10 Cervical SCI and 10 Thoracic SCI who meet eligibility criteria

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College Hospital

London, SE5 9RS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Aminul Ahmed

    King's College London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Azharul Khan

CONTACT

07932554463azharul.khan@nhs.net

Aminul Ahmed

CONTACT

02032992545aminul.ahmed@kcl.ac.uk

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2023

First Posted

October 10, 2023

Study Start

July 1, 2023

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

October 10, 2023

Record last verified: 2023-10

Locations

GB(1)