Electromyography to assess change in muscle activity as a result of intrathecal baclofen treatment
ID
Source
Brief title
Condition
- Neuromuscular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is the change in muscle activity measured by EMG. The
change in muscle activity is assessed by analysis of the amplitude, the root
mean square, the power spectral density and the co-contraction index of the EMG
signals. The EMG signals are measured during rest, during the MAS assessment
and during voluntary contraction by the participant.
Secondary outcome
Secondary study parameters are the MAS indices of the participants before and
after ITB treatment and the Patient Global Impression of Change reported by the
participants, and the correlation between de EMG features and MAS and PGIC.
Background summary
Baclofen is a muscle relaxant drug that is used in the treatment of spasticity.
The dose of baclofen must be set accurately, else the patient will either have
no treatment of the baclofen or will lose the functionality of the healthy
muscles that still respond. Side effects of oral baclofen include drowsiness
and sedation, nausea, hypotension, dizziness, headaches and more.
Intrathecal delivery of baclofen can be a possible alternative for patients
presenting with severe side effects or little therapeutical benefit of oral
baclofen. When using intrathecal baclofen delivery, an implanted pump with a
refillable reservoir delivers low dosages of baclofen through a catheter into
the intrathecal space throughout the day. The local delivery of baclofen
increases the concentration levels at the target and decreases the chance of
(systemic) side effects. Patients possibly benefiting from intrathecal baclofen
(ITB) must pass an initial trial, before a permanent ITB system can be
implanted.
Effects of oral baclofen and ITB are established using the Modified Ashworth
Scale (MAS), which grades muscle tone by moving limbs while assessing
resistance to the movement, and patient experience. Both these methods are
limited in reliability and are poorly correlated. Ideally, the effect of the
administered dose of ITB would be assessed using a more objective method.
Electromyography (EMG) is a promising tool for objective monitoring of the
effect of ITB on muscle activity.
Study objective
Electromyography to assess change in muscle activity as a result of intrathecal
baclofen treatment
Study design
This study is a mono-centre, prospective, explorative study
Study burden and risks
The participants receive standard care. The only addition is the measurement of
muscle activity using EMG during the MAS assessment. EMG measurement is a
non-invasive measurement with negligible risk. MAS assessment is part of the
standard procedures. The equipment, software and sensors used in this study are
tested for neurophysiological measurements and part of standard care.
The participants participating in this research will not be exposed to any
significant risks as a result of the research. This study can only be done
using this patient group.
Dr Molewaterplein 40
Rotterdam 3015 GD
NL
Dr Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
• Receiving an intrathecal baclofen trial (single shot baclofen test or
external intrathecal baclofen pump implantation) or permanent intrathecal
baclofen pump implantation
• Unilateral or bilateral spasticity of lower limbs
• Modified Ashworth Scale and electromyography measurements possible (18,5 *
BMI < 30)
• Able to understand and comply to verbal instructions
Exclusion criteria
• Age under 18 years old
• High sensitivity of lower limb skin
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 |
|---|---|
| CCMO | NL83951.078.23 |