Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05991804 |
| Other study ID # |
319893 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 28, 2023 |
| Est. completion date |
April 16, 2025 |
Study information
| Verified date |
August 2023 |
| Source |
University College, London |
| Contact |
Joseph Steel, BSc |
| Phone |
02089095500 |
| Email |
joseph.steel[@]nhs.net |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In the United Kingdom, there are more than 1000 new cases of spinal cord injury (SCI) each
year, with around half of these injuries affecting the cervical spine. People who have
reduced function and control affecting their upper limbs may have difficulty carrying out
activities of daily living (ADLs), significantly affecting their independence. Recovering
even partial upper limb function is a top priority among tetraplegics.
Regaining voluntary function in the upper limb can have a huge impact on quality of life.
Using TSCS in the upper limb for acute SCI can benefit patients early in their
rehabilitation, and may reduce the number of patients with problematic spasticity at
discharge. Transcutaneous spinal cord stimulation (TSCS) may provide a low-cost method of
improving function and spasticity in this cohort.
We are investigating the effect of adding non-invasive SCS to inpatient rehabilitation on
upper limb function for people with acute SCI. We will test this by randomly assigning
volunteers to either a control group, who will receive their normal inpatient rehabilitation
only, and an intervention group, who will have non-invasive SCS added to their normal
inpatient rehabilitation, targeting their upper limbs.
Description:
Recruitment:
Participants will be recruited from the Royal National Orthopaedic Hospital. A member of our
research team will contact participants after they have received this information sheet to
discuss participation in the study and answer any questions. People who would like to take
part in the study will be asked to attend an initial session to see if they are able to
tolerate non-invasive SCS.
Intervention:
Eligible participants will then be randomised into either the control group, where they will
receive their standard inpatient rehabilitation only, or into the intervention group, where
they will have non-invasive SCS added to their inpatient rehabilitation, targeting the arms
and hands.
For both the control and intervention groups, we will carry out regular assessments. Some of
these assessments will be part of standard care as an inpatient at the RNOH, and others will
be additional. Please see the outcome measures for further information about these
assessments.
Follow-up:
When participants have finished their inpatient rehabilitation at the RNOH, we will carry out
a semi-structured interview, where we will ask about participants' experience on this study.
Interviews may take place in person, over the phone, or over video call (e.g. Microsoft Teams
or Zoom).
After participants have been discharged from the RNOH, we will contact you to do some
follow-up assessments, which can be done at home or over the phone. There will be 2 follow-up
assessments, the first will be done at 6-months post-injury, and the second will be done at
1-year post-injury. If participants are already 6-months post-injury at discharge, then the
first follow-up assessment will be done at 1-month post-discharge, and the second at 1-year
post-injury. The follow-up assessments will be the TUAQ, and the SCI-QoL.
