Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05198921 |
| Other study ID # |
ULleida1 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 2024 |
| Est. completion date |
March 2025 |
Study information
| Verified date |
May 2023 |
| Source |
Universitat de Lleida |
| Contact |
CLAUDIA ARUMI |
| Phone |
630004767 |
| Email |
claudia.arumi[@]hotmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Cerebral palsy describes a group of permanent disorders of the development of movement and
posture, causing activity limitation that are attributed to non-progressive disturbances that
occurred in the developing fetal or infant brain.
Nowadays, CP is not fully curable, and physiotherapy should be used in conjunction with other
interventions such as oral drugs, botulinum toxin type A, continuous pump-administered
intrathecal baclofen, orthopaedic surgery and selective dorsal rhizotomy. However, several
systematic reviews conclude that there is low evidence that these invasive therapies are more
effective than placebo.
Repetitive transcranial magnetic stimulation (rTMS) is a type of neuromodulatory technique
through magnetic impulses. The effect of rTMS depends on the frequency of the emitted
electromagnetic field; low frequencies (≤1 Hz) lead to an inhibition of neuronal electrical
activity at the stimulation site, while high frequencies (≥3 Hz) cause neuronal
depolarization.
The objective of the project is to evaluate the effectiveness of a repetitive Transcranial
Magnetic Stimulation (rTMS) protocol, as an adjunct treatment to neurorehabilitation to
improve gross motor function and quality of life in school-age children with spastic
diplegia-type infantile cerebral palsy.
Description:
Cerebral palsy describes a group of permanent disorders of the development of movement and
posture, causing activity limitation that are attributed to non-progressive disturbances that
occurred in the developing fetal or infant brain.
The reported worldwide prevalence rates of CP are approximately between 2 and 3 per 1000 live
births. In Spain, it is estimated that between 2 and 2.5 per thousand born has cerebral
palsy, that is, 1 per in 500 live births. In other words, in Spain there are 120,000 people
with cerebral palsy.
The Spastic Diplegia form is the most common form with around 65-70 % of the CP children. It
is characterized by gross motor difficulties, marked in the lower limb and partially
affection noticeable in the upper limb.
Spasticity is defined as "disordered sensori-motor control, resulting from an upper
motoneuron lesion, presenting as intermittent or sustained involuntary activation of
muscles". Spasticity is a velocity-dependent motor disorder, characterized by an increased
stretch reflex, resulting in immoderate muscle activation that causes a muscle hypertonia.
The pathophysiology of spasticity is characterized, in general, by a deregulation of the
motor pathways (mainly the corticospinal, reticulospinal, and the vestibulospinal tracts)
running from the cerebral cortex, and brain stem to the spinal cord. In children who suffer
from an early brain abnormality, spasticity is affected by the reorganization of supraspinal
input and impaired motor maturation, causing a loss in descending inhibitory inputs and an
increase of the excitability of gamma and alpha neurons.
NICE clinical guidance recommends the use of physiotherapy, as it provides an approach
centred on how the current functional problems impact on the participation at home, school
life and community. Nowadays, CP is not fully curable, and physiotherapy should be used in
conjunction with other interventions such as oral drugs, botulinum toxin type A, continuous
pump-administered intrathecal baclofen, orthopaedic surgery and selective dorsal rhizotomy.
However, a recent Cochrane Systematic Review (CSR) concludes that there is low evidence that
BoNT-A is more effective than placebo or a non-placebo control in children with CP. Another
recent CSR determines that there is short-term evidence of the Intrathecal Baclofen therapy.
Furthermore, there is not a CSR for orthopaedic surgery and selective dorsal rhizotomy.
Non-invasive brain stimulation Repetitive Transcranial Magnetic Stimulation (rTMS) is a type
of neuromodulator technique in which trains are emitted from multiple magnetic pulses. The
effect of rTMS depends on the emitted electromagnetic field frequency; low frequencies (≤1
Hz) lead to an inhibition of neural electrical activity at the stimulation site, while high
frequencies (≥3 Hz) cause neuronal depolarization. It has been reported that rTMS stimulation
of prefrontal and motor cortical areas gives rise to trans synaptic activation of subcortical
circuits which are responsible for motor activity and reduction of muscle spasticity. That
is, an increase in the activity in the motor cortex, increases the inhibitory input to the
corticospinal tract and reduces the hyperactivity of the gamma and alpha neurons.
In terms of scientific evidence, some researchers have already studied the effect of rTMS
over standard therapy in decreasing muscle tone in CP patients, such as Gupta et al. who
demonstrated better results on the group who carried out the treatment compared to the
control group. Lal Rajak et al. studied how the number of therapy sessions of rTMS would
improve the motor development by reducing muscle spasticity in children with CP, and
concludes that the group which carried out more sessions, showed better improvements. Gupta
and Lal Rajak also studied the efficacy of different pulses by a constant frequency. They
found that in diplegic patient's, the gross motor function improved by 3.04%, 4.62% and 5.95%
in groups of 1500 pulses, 2000 pulses and 2500 pulses, respectively.
However, all the randomized controlled trials (RCTs) conducted as of yet, showed limitations
on the methodological quality. They all presented a very small sample size, which makes
difficult to conclude that the therapy is effective. Moreover, neither did an evaluation in
the middle of the treatment, only at the beginning and at the end, so it is not known if the
therapy begins to produce effect sooner, and none of them conducted long-term monitoring
results. Additionally, they only used one evaluation measure, the Modified Ashworth scale.
Besides, none of the RCTs took into account the family or carers, which have a main role on
making decisions and care planning.
