This study has been transitioned to CTIS with ID 2023-508143-51-01 check the CTIS register for the current data. Objective: The primary aim of the study is to demonstrate that cervical administered ITB is a safe treatment of spasticity of the UE…
ID
Source
Brief title
Condition
- Spinal cord and nerve root disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Objective:
The primary goal of the study is to demonstrate that cervical admission of ITB
is a safe treatment without deterioration of pulmonary and respiratory function
and possible increased risk or increased severity of SAS.
pulmonary function is mapped by means of spirometry. The quality of the
respiration is determined by capillary blood gas. Sleep-related breathing
disorders are measured by pulse-oximetry and polysomnography.
Secondary outcome
Secondary objective:
Secondary goal of the research is to explore the effect of cervical admission
of ITB on reduction of spasticity (both functional en satisfaction) and
improvement at the level of patients functions and activities.
Spasticity: This is measured by Perceived Resistance to Passive Movement (PRPM).
Patient satisfaction: This is measured by Patient Global Impression of Change
(PGIC).
The following parameters are already usual care before, during and after ITB
trial phase in Roessingh:
Function level:
• Muscle strength core muscles UE and LE by MRC scale.
• Passive range of motion (ROM) UE and LE in degrees
Activity/participation level
• COPM
• Time up and go test
• 10 meter walking test
We will add to this usual care for current study:
Function level:
• Force lateral and cylinder grasp
Activity/participation level:
• GRASPP
• QIF-sf
pulmonary function is mapped by means of spirometry. The quality of the
respiration is determined by capillary blood gas. Sleep-related breathing
disorders are measured by pulse-oximetry and polysomnography
Background summary
Intrathecal baclofen (ITB) is a proven effective treatment of spasticity. The
effectiveness and safety of ITB treatment for lower extremity (LE) spasticity
is well established. Much less is known about effectiveness and safety for the
treatment of upper extremity (UE) spasticity. The concentration of baclofen in
the spinal fluid decreases with increasing distance from the catheter tip. In
theory to obtain an effect of ITB on spasticity of the UE the catheter tip
should be placed at cervical level.
However baclofen affects muscle tone, which may lead to a deterioration of
pulmonary function and respiration and to an increase in sleep-related
breathing disorders when administered cervical. In addition, however, reducing
spasticity of respiratory muscles could improve breathing and lung function,
and there would be no relationship with the development or worsening of
sleep-related disorders.
The scarce literature does not show congruent results. Our hypothesis is that
cervical ITB leads to reduction of spasticity and improvement of patient
function and satisfaction without adverse effect on pulmonary and respiratory
function and sleep-related breathing disorders.
Study objective
This study has been transitioned to CTIS with ID 2023-508143-51-01 check the CTIS register for the current data.
Objective: The primary aim of the study is to demonstrate that cervical
administered ITB is a safe treatment of spasticity of the UE without
deterioration of pulmonary function, respiration and sleep-related breathing
disorders.
Study design
This is a prospective intervention study.
Intervention
An intrathecal catheter is placed just below spinal cord injury level. This is
coupled to an extracorporal pump with baclofen. We will start with a dosage of
24 microgram/day. Depending on the effect, this is increased to a maximum of
200 micrograms per day.
If there is a possitive trial there is an indication for defenitive ITB
treatment
Study burden and risks
During the trial, there are the already known possible complications as seen
with the current ITB treatment. This concerns post-punctional headache,
meningitis and other infections. Given the possible effect on lung function,
respiration and sleep-related respiratory events, the trial will take place
under close observation in the MST in Enschede. All these effects are
reversible when the treatment is stopped. When there is a positive trial the
patient can benefit from a definitive treatment with ITB.
Roessinghsbleekweg 33
Enschede 7522 AH
NL
Roessinghsbleekweg 33
Enschede 7522 AH
NL
Listed location countries
Age
Inclusion criteria
Cervical spinal cord injury
Spasticity of upper extremities
Exclusion criteria
• Pregnancy
• Women of child bearing potential
• Nursing women
• Allergy baclofen
• Contra indication ITB (increased bleeding tendency, increased intracranial
pressure, severe pressure ulcer)
• Oral anticoagulants
• Severe depression
• excessive alcohol use
• Patients depending on ventilation
• Not adequately treated SAS
• PcCO2 > 6,5 KPa
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EU-CTR | CTIS2023-508143-51-01 |
| EudraCT | EUCTR2021-004994-30-NL |
| CCMO | NL68837.091.21 |