Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05801536 |
| Other study ID # |
NMN007 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 13, 2022 |
| Est. completion date |
May 1, 2024 |
Study information
| Verified date |
June 2024 |
| Source |
University of Leeds |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Following a cervical spinal cord injury (cSCI; damage to the spinal cord at the neck) there
is catastrophic loss of hand and grip function. This has a devastating effect on quality of
life and functional independence. Thus, there is a real need to identify and optimise therapy
to aid functional arm and hand recovery. One such therapy is Transcutaneous Electrical
Stimulation (tCES). This involves applying sticky pads to the skin and then transmitting a
low-level electrical current to the spinal cord. This activates neural circuits, allowing
injured nerves to transmit signals to muscles to produce movement while completing upper limb
tasks. The purpose of this pilot project is to establish if and how tCES might be used to
improve arm and hand control. The investigators will recruit 8 people who have had a cSCI for
>1yr. First, the investigators will invite volunteers to the University for 2 weeks, twice
per week, to establish their baseline movement capacity.
Then the investigators will allocate the volunteers to one of two groups: group 1 will
undertake 4 weeks of upper limb task practice (ULTP) followed by 4 weeks of ULTP+tCES; group
2 will undertake ULTP+tCES for 4 weeks followed by 4 weeks of ULTP. Participants will then
complete a week (2 sessions) of post-intervention assessment. The investigators will then
invite volunteers and carers to be interviewed about their experiences of being involved in
the project. Finally, there will be 2 sessions of follow-up assessment after 3 months. In
order to assess if and how ULTP+tCES affects arm and hand control the investigators will
measure: movement capacity using standard clinical tests; muscular activity in response to
brain/spinal stimulation; how fast and smooth movements are when reaching and grasping
objects. The investigators will also examine how the intervention has affected Quality of
Life (QoL) and independence (Spinal Cord Independence Measure).
Description:
Spinal cord injury (SCI) can be defined as a loss of communication between the brain and the
body due to damage to pathways within the spinal cord. Injury to the cervical levels of the
spinal cord are more common than injury to the lower segments of the spinal cord, thus
tetraplegia is more common than paraplegia (Thompson et al., 2014). Tetraplegics rank
regaining arm and hand function as their main priority for rehabilitation, five times greater
than bowel, bladder, sexual or lower extremity function (Anderson, 2004). However, compared
to recent advances made in recovery of ambulatory function, research that strives to uncover
how best to optimise arm/hand rehabilitation after SCI is very limited. Thus identifying and
optimising efficacious therapies to restore functional arm and hand recovery is an important
clinical, economic and social goal.
While promising molecular strategies have emerged to reduce secondary injury and promote
axonal regrowth, an effective cure eludes people with cervical SCI, and overall recovery of
arm and hand function using these means remains limited (Levi et al., 2018). Functional
training, or task specific training of a motor function (e.g. reaching and grasping), is
currently the most effective evidence-based way of enhancing plasticity to recover motor
function. A promising approach is the use of stimulation-based rehabilitative therapies
promoting neural plasticity along the spinal cord/corticospinal tract. Among these,
transcutaneous electrical stimulation (TCES) (Gerasimenko et al., 2015) was demonstrated to
be effective for improving hand grip strength in people with spinal cord injury (Gad et al.,
2018). The investigators hypothesise that combining upper limb practice (ULTP) and TCES to
the cervical spinal cord over the course of 4 weeks, could affect arm/ hand function and
quality of life to a greater extent than ULTP by itself.
The principal aim of the study is to test the effects of transcutaneous electrical
stimulation on arm and hand functions in individuals with cervical spinal cord injury. In
addition, the investigators aim to assess the neurophysiological mechanisms with which
transcutaneous electrical stimulation supports the observed changes in hand/arm function.
The primary objective of the study is to measure and compare the changes in hand and arm
functions, assessed through the Graded and Redefined Assessment of Strength, Sensibility and
Prehension test (GRASSP) tool, occurring over the course of the two interventions (ULTP and
ULTP + TCES). In addition, secondary objectives are:
To explain the neurophysiological mechanisms with which transcutaneous electrical stimulation
results in changes in hand/arm function.
To establish a clearly defined, reproducible protocol for establishing participant specific
TCES settings.
To understand factors that contribute to participants wanting to use TCES and their
experience of using TCES.
The study will consist of two weeks of baseline measurements, 8 weeks of intervention (4
weeks of ULTP and 4 weeks of TCES + ULTP) in a cross-over design, followed by two-weekly and
a 3 month follow-up with no further intervention (Inanici et al., 2018). The baseline
measurements (see primary and secondary outcome measures) are necessary to document stability
of functional status. Baseline measures will take place over 2 sessions, each week (e.g. 4
baseline testing sessions).
Participation to the study will span over the course of 25 weeks. On the first 2 weeks,
participants will attend the lab twice per week. On the following 8 weeks, participants will
attend the lab three times per week. On week 11, participants will attend the lab twice. On
week 12, participants and their carers will be invited to a semi-structured interview. There
will then be a 3-months break during which the participants are not required to attend the
lab, after which (week 25) they will take part on two follow-up sessions.
