Research with human participants

Overview of medical research in the Netherlands

A randomized, controlled, open-label, parallel-group, multi-center study to compare the effect of Intrathecal Baclofen Therapy (ITB Therapy®) versus Best Medical Treatment (BMT) on spasticity in post-stroke patients after 6 months active treatment

Published:
Last updated:

The objective is to determine whether ITB Therapy is more effective than oral anti-spasticity agents in reducing the spasticity.

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Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Central nervous system vascular disorders
Study type
Interventional

ID

NL-OMON39143

Source

ToetsingOnline

Brief title

SISTERS: Spasticity in Stroke * Randomized Study

Condition

  • Central nervous system vascular disorders

Synonym

spasticity, stroke

Research involving

Human

Sponsors and support

Primary sponsor :
Medtronic
Source(s) of monetary or material Support :
bedrijf

Intervention

Keyword :
Baclofen, Spasticity, Stroke, SynchroMed

Outcome measures

Primary outcome

degree of reducing the spasticity in the lower extremities on the Ashworth

Scale (AS)

Secondary outcome

- Side effects

- Differences in efficacy between the 2 groups through tests and questionnaires

Background summary

Until now there has been no research on the difference in efficacy between ITB
(Intrathecal Baclofen) Therapy and BMT (Best Medical Treatment) in patients
with severe spasticity after a stroke.

Study objective

The objective is to determine whether ITB Therapy is more effective than oral
anti-spasticity agents in reducing the spasticity.

Study design

Randomised open label study

Intervention

Group 1:
Implantation pump
Intrathecal baclofen

Group 2:
Commonly used oral drugs with spasticity.

Study burden and risks

Risk is minimal because the treatment method is common and known.
Risks are side effects, surgery and implantation of the pump.
Burden might be that it might cost the patient more time than usual, but the
patient will receive more attention.

Public
Medtronic

Route du Molliau 31
Tolochenaz 1131
CH
Scientific
Medtronic

Route du Molliau 31
Tolochenaz 1131
CH

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

- 18-75 years old
- stroke not more than 6 months ago
- spasticity in 2 extremities
- Ashworth score > 2
- patient suitable acc. Adult Spasticity Algorithm (not enough effect with other treatments)
- stable blood pressure
- not pregnant

Exclusion criteria

- acute systemic infection
- presence of pacemaker, ICD, neurostimulator, drug delivery system
- oncontrolled refractoire epilepsy
- use of vitamin K antagonists
- preganant or breast feeding
- Botuline toxine injection less than 4 months ago
- Patient not able to give his/her informed consent himself/herself

Design

Study phase :
4
Study type :
Interventional
Intervention model
:
Parallel
Allocation :
Randomized controlled trial
Masking :
Open (masking not used)
Control :
Active
Primary purpose :
Treatment

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
5
Type :
Actual

Medical products/devices used

Generic name :
SynchroMed infusion system
Registration
:
Yes - CE intended use
Product type :
Medicine
Brand name :
Lioresal
Generic name :
Baclofen
Registration
:
Yes - NL intended use

Approved WMO
Date :
Application type :
First submission
Review commission :
METC academisch ziekenhuis Maastricht/Universiteit Maastricht, METC azM/UM (Maastricht)
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC academisch ziekenhuis Maastricht/Universiteit Maastricht, METC azM/UM (Maastricht)
Approved WMO
Date :
Application type :
First submission
Review commission :
METC academisch ziekenhuis Maastricht/Universiteit Maastricht, METC azM/UM (Maastricht)
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC academisch ziekenhuis Maastricht/Universiteit Maastricht, METC azM/UM (Maastricht)
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC academisch ziekenhuis Maastricht/Universiteit Maastricht, METC azM/UM (Maastricht)
Approved WMO
Date :
Application type :
Amendment
Review commission :
MEC academisch ziekenhuis Maastricht/Universiteit Maastricht, MEC azM/UM (Maastricht)
Approved WMO
Date :
Application type :
Amendment
Review commission :
MEC academisch ziekenhuis Maastricht/Universiteit Maastricht, MEC azM/UM (Maastricht)

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
EudraCT EUCTR2009-011216-38-NL
CCMO NL27977.068.09
Other NTC01032239