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SISTERS: Spasticity In Stroke Study - Randomized Study (SISTERS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01032239
Recruitment Status : Completed
First Posted : December 15, 2009
Last Update Posted : October 12, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
To demonstrate that Intrathecal Baclofen (ITB) Therapy, compared to Best Medical Treatment (BMT), has superior efficacy in the treatment of severe spasticity in adult post-stroke patients with generalized spastic hypertonia who have not reached their therapy goal with other treatment interventions assessed by a decrease in the average Ashworth Scale (AS) score in the lower extremities.

Condition or disease Intervention/treatment Phase
Severe Spasticity Drug: intrathecal baclofen Phase 4

Detailed Description:

This is a randomized, controlled open-label parallel group study to demonstrate the efficacy benefit of ITB Therapy over BMT in post-stroke patients with severe spasticity who have not reached their therapy goal with other treatment interventions.

In order to evaluate the efficacy benefit of ITB Therapy over BMT in post-stroke patients, a two-arm parallel group design will be applied. Patients will be equally randomized to one of two treatment arms:

  1. ITB Therapy arm; or
  2. BMT arm

The study consists of a run-in phase of 21 days for the BMT treatment arm and 2-25 days for the ITB Therapy treatment arm, followed by a 6 month active trial.

The BMT treatment arm will receive a combination of oral antispastic medication and physiotherapy. Patients must be prescribed at least one or a combination of the following oral antispastic medications: oral baclofen, tizanidine, diazepam (or other benzodiazepines) or dantrolene. Following the run-in phase, patients will enter the 6 month active trial.

The ITB Therapy treatment arm will receive a combination of ITB Therapy and physiotherapy. During the run-in phase, a test with intrathecal baclofen will be performed to evaluate the response of the patient. Patients fulfilling the test success criterium will be implanted with a Medtronic SynchroMed®II infusion system. Following implant, patients will enter into the 6 month active trial, which includes a 6 week titration phase, during which time oral antispastic medications must be gradually reduced with complete discontinuation by the end of the titration period.

During the 6 month active trial, patients will be assessed at 3 and 6 months. All primary and secondary endpoint assessments will be performed by a blinded assessor.

The total study duration is expected to be 60 months, including a 39 month enrollment period. The total duration per patient is approximately 7 months (approximately 1 month run-in period followed by 6 months active treatment).

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled, Open-label, Parallel-group, Multi-center Study to Compare the Effect of Intrathecal Baclofen Therapy Versus Best Medical Treatment on Severe Spasticity in Post-stroke Patients After 6 Months Active Treatment
Study Start Date : November 2009
Primary Completion Date : September 2016
Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Baclofen
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: ITB therapy
Intrathecal Baclofen therapy (Intrathecal baclofen + implantable pump)
Drug: intrathecal baclofen
ITB test, implant, 6 months follow-up
No Intervention: Best Medical Treatment (BMT)
Use one or a combination oral antispastic medication.

Outcome Measures

Primary Outcome Measures :
  1. Ashworth scale [ Time Frame: Baseline, 3 months and 6 months ]

Secondary Outcome Measures :
  1. To evaluate safety by evaluating Adverse Event occurence. [ Time Frame: Baseline, 3 months, 6 months and every other visits ]
  2. To evaluate the differences between ITB Therapy and BMT [ Time Frame: Baseline, 3 months, 6 months and every other visits ]

    The differences between ITB Therapy and BMT are evaluated through:

    1. Spasticity in the upper extremities assessed by AS
    2. Function assessed by Functional Independence Measure
    3. Function assessed by 10 meter timed walking test
    4. Function assessed by ability to transfer
    5. Pain assessed by Numeric Pain Rating Scale (NPRS)
    6. Primary therapy goal achievement assessed by Goal Attainment Scale (GAS)
    7. Quality of Life (QoL) assessed by EuroQol group-5 Dimensional (EQ-5D)
    8. QoL assessed by the SF-12
    9. QoL assessed by the Stroke Specific -Quality of Life (SS-QoL)
    10. Satisfaction with the therapy assessed by Likert Scale
    11. Healthcare resource utilization

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

To be eligible for inclusion into this study, patients must fulfill all of the following criteria prior to study enrollment:

  1. patient (or legal guardian) has been informed of the study procedures and has given written informed consent
  2. patient experienced last stroke > 6 months prior to enrollment
  3. patient presents spasticity in at least 2 extremities
  4. patient presents an Ashworth score ≥ 3 in a minimum of two of the affected muscle groups in the lower extremities
  5. patient is eligible to receive ITB Therapy following the Adult Spasticity Algorithm. A patient does not reach his/her therapy goal with other treatment interventions
  6. stable blood pressure: no change in hypertensive medication in last month (NOTE: ventriculoperitoneal shunts and valves can be present)
  7. if female, she must either be post-menopausal or surgically sterilized; or use a hormonal contraceptive, intrauterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study
  8. patient/family is willing to comply with study protocol including attending the study visits

Exclusion criteria:

To be eligible for inclusion in this study the patients must not meet any of the following criteria:

  1. patient/family is considered by the physician to be unable or unwilling to participate in long-term ITB Therapy management
  2. patient has known hypersensitivity to baclofen
  3. active systemic infection (NOTE: pressure sores are not a contraindication unless they are present near the implant sites)
  4. presence of a cardiac pacemaker, ICD, implantable neurostimulator or drug delivery device
  5. uncontrolled refractory epilepsy
  6. use of oral vitamin K antagonists, e.g. warfarin/coumadin; unless the patient can switch to another accepted anticoagulant (e.g. heparin, aggrenox, fragmin, plavix, ticlid) for the period of ITB test and implant
  7. patient is pregnant or breastfeeding
  8. patient received a Botulinum toxin injection less than 4 months ago
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01032239

  Show 25 Study Locations
Sponsors and Collaborators
Medtronic International Trading Sarl
Principal Investigator: Leopold SALTUARI, Prof. Landeskrankenhaus Hochzirl, Zirl (Austria)
More Information

Responsible Party: Medtronic International Trading Sarl
ClinicalTrials.gov Identifier: NCT01032239     History of Changes
Other Study ID Numbers: 1.02.7001
First Posted: December 15, 2009    Key Record Dates
Last Update Posted: October 12, 2016
Last Verified: October 2016

Keywords provided by Medtronic International Trading Sarl:
Severe spasticity in post-stroke patients

Additional relevant MeSH terms:
Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms