SISTERS: Spasticity In Stroke Study - Randomized Study

NCT01032239 | Completed Phase 4 Results DMC

• 1 other identifier: 1.02.7001
• Study Type: interventional
• Target: 61
• Locations: 9 countries
• Sites: 25

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.

Conditions

Severe Spasticity

Keywords

Severe spasticity in post-stroke patients

Outcome Measures

Primary Outcomes (1)

• Change in Average Ashworth Scale (AS) in Affected Lower Extremities From Baseline to Month 6

  AS is a manual test, measuring the resistance to passive movement about a joint with varying degrees of velocity. Scores range from 1-5, with 5 choices. A score of 1 indicates no resistance, and 5 indicates rigidity. The following muscle groups in the lower extremities were assessed: hip flexors, hip adductors, knee extensors, knee flexors, plantar flexors and ankle-dorsal flexors. Average AS was calculated as the average of AS scores of the 6 muscles of the affected lower extremity. Change in average AS in affected lower extremities from baseline to month 6 between ITB and BMT arm was assessed. Change= AS at month 6 - AS at baseline.

  Baseline and month 6

Secondary Outcomes (11)

• Change in Average Ashworth Scale (AS) in Affected Upper Extremities From Baseline to Month 6

  Baseline and month 6

• Change in Functional Independence Measure (FIM) Score From Baseline to Month 6

  Baseline and month 6

• Change in Average 10 Meter Time Walking Test (10MTWT) From Baseline to Month 6

  Baseline and month 6

• Number of Participants Who Were Able to Transfer From the Wheelchair to Bed Without Human Assistance

  baseline, month 3, month 6

• Change in Numeric Pain Rating Scale (NPRS) From Baseline to Month 6

  Baseline and month 6

Study Arms (2)

ITB therapy

ACTIVE COMPARATOR

Intrathecal Baclofen therapy (Intrathecal baclofen + implantable pump)

Drug: intrathecal baclofen

Best Medical Treatment (BMT)

NO INTERVENTION

Use one or a combination oral antispastic medication.

Interventions

intrathecal baclofen DRUG

ITB test, implant, 6 months follow-up

ITB therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient (or legal guardian) has been informed of the study procedures and has given written informed consent
• patient experienced last stroke \> 6 months prior to enrollment
• patient presents spasticity in at least 2 extremities
• patient presents an Ashworth score ≥ 3 in a minimum of two of the affected muscle groups in the lower extremities
• 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
• stable blood pressure: no change in hypertensive medication in last month (NOTE: ventriculoperitoneal shunts and valves can be present)
• 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
• patient/family is willing to comply with study protocol including attending the study visits

You may not qualify if:

• patient/family is considered by the physician to be unable or unwilling to participate in long-term ITB Therapy management
• patient has known hypersensitivity to baclofen
• active systemic infection (NOTE: pressure sores are not a contraindication unless they are present near the implant sites)
• presence of a cardiac pacemaker, ICD, implantable neurostimulator or drug delivery device
• uncontrolled refractory epilepsy
• 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
• patient is pregnant or breastfeeding
• patient received a Botulinum toxin injection less than 4 months ago

Sponsors & Collaborators

• MedtronicNeuro: lead

Study Sites (25)

University of California Irvine

Irvine, California, 92697, United States

Location

MedStar National Rehabilitation Network

Washington D.C., District of Columbia, 20010, United States

Location

Design Neuroscience Center

Doral, Florida, 33172, United States

Location

Rehabilitation Medical Group - Florida Hospital

Orlando, Florida, 32806, United States

Location

Tallahassee Neurological Clinic Department of Neurosurgery

Tallahassee, Florida, 32308, United States

Location

Saint Alphonsus Regional Med Center

Boise, Idaho, 83704, United States

Location

Research Medical Center

Kansas City, Missouri, 64132, United States

Location

Einstein Hospital/Moss Rehabilitation

Elkins Park, Pennsylvania, 19027-2220, United States

Location

TIRR Memorial Herman Hospital

Houston, Texas, 77030, United States

Location

Sozialmedizinisches Zentrum Baumgartner Höhe Otto-Wagner-Spital

Vienna, 1140, Austria

Location

Landeskrankenhaus Hochzirl

Zirl, 6170, Austria

Location

Clin. Univ. UCL Saint Luc

Brussels, 1200, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

Universitaire Ziekenhuizen Leuven, campus Pellenberg

Leuven, B-3000, Belgium

Location

Kliniken Beelitz GmbH Neurologische Rehabilitationsklinik

Beelitz-Heilstätten, 14547, Germany

Location

Ambulantes Neurologisches Rehabilitationszentrum

Bonn, 53117, Germany

Location

Therapiezentrum Burgau

Burgau, 89331, Germany

Location

Rhein-Sieg-Klinik Dr. Becker Klinikgesellschaft

Nümbrecht, 51588, Germany

Location

Centro di Riabilitazione "Villa Beretta"

Costa Masnaga, 23845, Italy

Location

Fondazione Salvatore Maugeri Clinica del lavoro e della riabilitazione IRCSS

Pavia, 27100, Italy

Location

Afdeling Revalidatie Academisch Ziekenhuis Maastricht

Maastricht, 6229, Netherlands

Location

Univerzitetni rehabilitacijski inštitut Republike Slovenije Soča

Ljubljana, 1000, Slovenia

Location

Fundació Privada Institut de Neurorehabilitació Guttmann, Badalona

Barcelona, 08916, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

St George's Hospital

London, SW17 0 QT, United Kingdom

Location

Related Publications (2)

• Creamer M, Cloud G, Kossmehl P, Yochelson M, Francisco GE, Ward AB, Wissel J, Zampolini M, Abouihia A, Calabrese A, Saltuari L. Effect of Intrathecal Baclofen on Pain and Quality of Life in Poststroke Spasticity. Stroke. 2018 Sep;49(9):2129-2137. doi: 10.1161/STROKEAHA.118.022255.

  PMID: 30354975 DERIVED

• Creamer M, Cloud G, Kossmehl P, Yochelson M, Francisco GE, Ward AB, Wissel J, Zampolini M, Abouihia A, Berthuy N, Calabrese A, Loven M, Saltuari L. Intrathecal baclofen therapy versus conventional medical management for severe poststroke spasticity: results from a multicentre, randomised, controlled, open-label trial (SISTERS). J Neurol Neurosurg Psychiatry. 2018 Jun;89(6):642-650. doi: 10.1136/jnnp-2017-317021. Epub 2018 Jan 11.

  PMID: 29326296 DERIVED

MeSH Terms

Conditions

Muscle Spasticity

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Alessandra Calabrese, PhD
• Organization: Medtronic Clinical Neuromodulation

alessandra.calabrese@medtronic.com

Study Officials

• Leopold SALTUARI, Prof.

  Landeskrankenhaus Hochzirl, Zirl (Austria)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2009
• First Posted: December 15, 2009
• Study Start: November 1, 2009
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: February 15, 2018
• Results First Posted: February 15, 2018

Record last verified: 2018-01

Locations

AU (2); DE (4); IT (2); US (9); BE (3); GB (1); ES (2); SL (1); NL (1)