Reduce post-stroke spasticity
Reduce post-stroke spasticity

What is ITB TherapySM?

Intrathecal baclofen (ITB) therapy delivers drugs directly to the cerebrospinal fluid (CSF) in the intrathecal space via a catheter and an implanted programmable pump.

ITB Therapy
 

ITB is an effective therapy to reduce spasticity

ITB therapySM has been proven to significantly reduce spasticity in both lower and upper limbs, as measured by (modified) Ashworth scale (-1.5 and -1.0, p<0.01) after one year of treatment.4,5

ITB Therapy

ITB therapySM is proven to significantly improve function and quality of life of patients (p<0.05).4,5

ITB Therapy

ITB therapySMimproves muscle strength in the spasticity-affected limbs and does not alter the strength in the unaffected limbs.4,5

73% of patients are satisfied with spasticity reduction and would recommend the therapy.6

ITB Therapy
Satisfied

ITB THERAPYSM is superior to oral medication

ITB therapySM shows superior efficacy in reducing spasticity of lower and upper limbs vs. oral antispasticity medication as measured by Ashworth scale. Lower -1 vs. -0.4 CMM; upper -0.7 vs. -0.2 CMM (p<0.05).7

ITB therapySM shows also superior efficacy in improving actual pain (ITB -1.17 vs CMM 0.00, p<0.05) and quality of life (EQ-5D utility score, ITB 0.09 vs CMM 0.01, p<0.05).6

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WHAT YOU CAN DO TODAY

Work as an interdisciplinary team

ITB Therapy

Actions

  • Recognise the signs of spasticity
  • Provide early information to patients and caregiver about spasticity
  • Identify patients with spasticity
  • Test the patient or refer to a specialist
  • Refer the patient for implantation of pump system
  • Implant SynchroMed™ II pump
  • Titration and follow up of ITB therapySM

Possible side effects and risks

Possible side effects of ITB therapySM

The most common side effects of ITB therapySM are related to the drug itself and include muscular weakness, hypotonia, urinary retention, falls, somnolence and dizziness.

Drug delivery parameters can be adjusted to minimise side effects.

The pump can be removed to return to the patient’s initial level of spasticity.

Procedure and system-related risks

Surgical complications are possible and include headaches, intracranial hypotension, spinal fluid leak and implant site infection.

Once the pump and the catheter are implanted, device complications (e.g., device dislocation, cathether occlusion) may occur that require surgery to resolve.7

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See the device manual for detailed information regarding the instructions for use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events. For further information, please contact your local Medtronic representative and/or consult the Medtronic website at www.medtronic.com.

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Important Reminder: This information is intended only for users in markets where Medtronic products and therapies are approved or available for use as indicated within the respective product manuals. Content on specific Medtronic products and therapies is not intended for users in markets that do not have authorization for use.

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1

Barnes MP, Johnson GR. Upper motor neurone syndrome and spasticity: Clinical management and neurophysiology. Cambridge University Press, 2008.

2

Penn RD. Intrathecal baclofen for spasticity of spinal origin: seven years of experience. J Neurosurg. 1992;77(2):236-240.

3

Meythaler JM, Guin-Renfroe S, Law C, et al. Continuously infused intrathecal baclofen over 12 months for spastic hypertonia in adolescents and adults with cerebral palsy. Arch Phys Med Rehabil. 2001;82(2):155-161

4

Ivanhoe CB, Francisco GE, McGuire JR, et al. Intrathecal baclofen management of poststroke spastic hypertonia: Implications for function and quality of life. Arch Phys Med Rehabil. 2006;87(11): 1509-15.

5

Schiess MC, Oh IJ, Stimming EF, et al. Prospective 12-month study of intrathecal baclofen therapy for poststroke spastic upper and lower extremity motor control and functional improvement. Neuromodulation. 2011;14(1):38–45

6

Creamer et al. Effect of intrathecal baclofen on pain and quality of life in poststroke spasticity: A randomized trial (SISTERS). Stroke. 2018;49:2129–2137.

7

Creamer M, Cloud G, Kossmehl P, et al. Intrathecal baclofen therapy versus conventional medical management for severe post-stroke spasticity: Results from a multicentre, randomised, controlled, open-label trial (SISTERS). J Neurol Neurosurg Psychiatry. 2018 Jun;89(6):642-650.