This project aims to investigate peripheral and central neuroplasticity following an early (
ID
Source
Brief title
Condition
- Spinal cord and nerve root disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Central plasticity via: Single pulse TMS (cortical mapping and rest motor
threshold) 8 weken after randomisation
Secondary outcome
Klinische maten: Upper Extremity Motor Score, Spinal Cord Independence Measure
(SClM-zelfzorg); Van Lieshout Test (VLT); Grades redefined assessment of
strength sensibility and Prehension (GRASSP); Hand-Held Dynamometrie;
accelerometrie (sessie densiteit: actievetherapietijd/sessie lengte); ervaring
moeilijkheid en ervaring intensiteit.
Centrale plasticiteit: Paired pulse TMS: (SICI; LICI; SICF); perifere
plasticiteit: NET (Nerve excitability testing) en MScanFit MUNE (Compound
muscle action potential (CMAP).
Background summary
Paralysis or paralysis is the most common effect of spinal cord injury (SCI) on
individuals. Paralysis affects the ability to walk, perform self-care, live
independently and participate in work and leisure activities. In individuals
with cervical spinal cord injury, arm and hand function is very important.
Motor training of the upper extremities can improve the functioning of. The
most promising and easily implemented intervention that could promote
neurological recovery and make a lasting difference in the lives of people with
spinal cord injury is early and intensive motor training aimed at recovery
below the injury level. This intervention takes advantage of the early
plasticity of the nervous system. By maximizing muscle activation in the first
few days after injury, we can target the nervous system's unique capacity for
neural plasticity where changes can occur in central and peripheral motor
systems.
Study objective
This project aims to investigate peripheral and central neuroplasticity
following an early (<13 weeks after injury) and intensive (8 weeks of 6 hours
of additional therapy) upper extremity motor training program (EIUMT) aimed at
recovery below the lesion level. This project has 4 objectives: to investigate
1) central neural plasticity(identify changes in cortical neuroplasticity and
corticospinal excitability; 2) peripheral neural plasticity (identify change in
axonal excitability and number of motor units); 3) clinical motor recovery of
the upper limbs and 4) relationships between dose dimensions of motor
intervention and clinical and neurophysiological outcome measures after EIUMT.
Advanced neurophysiological measurements and clinical measurements will be
taken before and after EIUMT, after 4 weeks, 8 weeks and at 6-month follow-up.
Study design
a multicenter pragmatic randomised controled study in 2 countries
Intervention
The intervention group receives 6 hours of motor training each week. This
involves active and targeted motor training of all affected muscles below the
injury level in the context of functional activities.
The control group receives only standard rehabilitation and care.
Study burden and risks
Benefits such as improved strength, balance and improvements in functional
movements may be noted. In addition, researchers will better understand how to
improve outcomes after spinal cord injury. There are minimal risks associated
with participating in this research project. Patients in this study may
experience discomfort due to receiving intensive therapy (i.e., 6h/week of
additional therapy on top of standard rehabilitation). However, the RCT from
Sydney University has been running for one year and few adverse events have
been reported. Therefore, we can assume that the risks of the intervention are
limited. Regarding measurements, the participant may experience some
discomfort, but no risk. With transcranial magnetic stimulation measurements,
it is possible that the participant may experience discomfort in the form of
tapping on the head. At high stimulation intensities there may be some
incidental stimulation of the muscles in the face, this may be experienced as a
jaw twitch or eye blink. Also, the magnetic pulse in the coil makes a loud
clicking sound, which gets louder at high intensities. Earplugs are available
for participants who wish to minimize any discomfort from the noise.
Participants will be screened for risk factors including presence of epilepsy
or pregnancy to participate in the transcranial magnetic stimulation
measurements. The complete protocol (treatment and measurements) will be
monitored by the rehabilitation physician and the treatment team. The benefits
namely the increased strength and better outcome for the intervention group and
the knowledge of the underlying mechanisms at the origin of neurological
recovery and plasticity, which are of interest to the whole paraplegic
population and caregivers, outweigh the expected disadvantages. Therefore,
asking patients to participate is justified.
Martelaerenlaan 41
Hasselt 3500
BE
Martelaerenlaan 41
Hasselt 3500
BE
Listed location countries
Age
Inclusion criteria
Inclusion criteria: Traumatic or non-traumatic C-SCI in the preceding 13 weeks;
age over 16 years; have an incomplete SCI or an AIS A SCI with zones of partial
motor paralysis (as defined
by the International Standards for the Neurological Classification of SCI
(ISNCI) and medically stable.
Exclusion criteria
Exclusion criteria: SCI with ASIA Impairment Scale (AIS) A without zones of
partial preservation (decided based on former studies [58]) and expertise of
the team; SCI with any significant medical condition that could prevent the
person from participating. In order to ensure TMS measurement can be performed,
patients will only be included in this WP if they have a positive response to
motor evoked potential measurement (MEP+) [59] and will be excluded in the
presence of contraindications for TMS application such as epilepsy, metal
implants in the brain, defibrillator, pacemaker and pregnancy.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
Other | is in progress |
CCMO | NL84212.015.23 |