SISTERS: Spasticity In Stroke Study - Randomized Study

• Ashworth scale [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]
  

• To evaluate safety by evaluating Adverse Event occurence. [ Time Frame: Baseline, 3 months, 6 months and every other visits ] [ Designated as safety issue: Yes ]
  
• To evaluate the differences between ITB Therapy and BMT [ Time Frame: Baseline, 3 months, 6 months and every other visits ] [ Designated as safety issue: No ]

  The differences between ITB Therapy and BMT are evaluated through:

  1. Spasticity in the upper extremities
  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
  6. Primary therapy goal achievement assessed by Goal Attainment Scale
  7. Quality of Life (QoL) assessed by EuroQol group
  8. QoL assessed by the Stroke Specific
  9. Satisfaction with the therapy assessed by Likert Scale
  10. Healthcare resource utilization
  
  

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 46 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).