SISTERS: Spasticity in Stroke – Randomized Study - v1 13 Mar 2009
Research type
Research Study
Full title
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 severe spasticity in post-stroke patients after 6 months active treatment
IRAS ID
23827
Contact name
Geoffrey Christopher Cloud
Contact email
Sponsor organisation
Medtronic International Trading Sàrl
Eudract number
2009-011216-38
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
Stroke is one of the leading causes of adult disability. After recovering from a stroke, patients frequently have motor weakness on one or both sides of the body. Further impairing mobility and function in these patients is spasticity. This abnormal, excessive muscle tone can cause many problems, including pain and interference with the ability to perform daily activities.
The SISTERS study aims to demonstrate the superior effect of ITB Therapy® using Lioresal® Intrathecal (ITB) over Best Medical Treatment (BMT) on spasticity in post-stroke patients after 6 months treatment.
Aside from the primary outcome measure, i.e. improvement in spasticity score, safety of the treatment and cost-utility will be assessed. Further evaluations will be on function, pain, therapy goal achievement and quality of life.
88 patients with severe post-stroke spasticity, who do not reach their therapy goals with other treatment interventions and whose treatment eligibility is confirmed at baseline, will be randomized to either ITB Therapy or to BMT.
In the ITB Therapy group, the patients will undergo a test with ITB Therapy. If this test is positive, i.e. the spasticity decreased, the patient will be implanted with a pump. After titration, the patients will be assessed at 6 weeks, 3 months and 6 months post-implant. If the test is negative, patient will be followed in the BMT group.
In the BMT group, the oral anti-spastic medication will be evaluated during a 3 weeks run-in period. After a short second assessment, these patients will have visits at 3 and 6 months.
20 rehabilitation sites in Europe and US will participate during 2 years.
SISTERS is a randomized, controlled, open-label, parallel-group, multi-centre study to compare the efficacy and safety of ITB Therapy® to Best Medical Treatment (BMT) on severe spasticity in post-stroke patients after 6 months active treatment.
The study is sponsored by Medtronic International Trading Sarl.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
10/H0803/96
Date of REC Opinion
20 Oct 2010
REC opinion
Further Information Favourable Opinion