Transitioning to a Valve-Gated Intrathecal Drug Delivery System (IDDS)
Transitioning to a Valve-Gated Intrathecal Drug Delivery System (IDDS): A Randomized, Controlled, Multi-center, Prospective Study Evaluating Dose Reduction in ITB Patients.
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Prometra II Programmable Pump - Flowonix Medical
What it measured
Main measures
Comparison of spasticity control with Synchromed II versus Prometra II
3 months
Spasticity
Other measures (1)
Comparison of patient report of spasm frequency with Synchromed II versus Prometra II
3 months
Spasticity
Who could take part
MS (type not specified) · 22 to 85
Show the full criteria
Inclusion criteria
* Be male or female between the ages of 22 and 85 years * Be capable of giving informed consent (or a legally authorized representative) and completing assessments required by the study * Have modified Ashworth scores within 3 months prior to valve-gated pump implant * Have an active existing SynchroMed II intrathecal drug delivery system needing replacement * Existing ITB patient with spasticity of any origin. * Have stable drug dosage for at least 3 months prior to valve-gated pump implant * Be an appropriate candidate for surgery * Be able to comply with required study visits and assessments including English proficiency
Exclusion criteria
* Be terminally ill and/or have a life expectancy of less than 12 months * Be a pregnant/lactating woman. * Have a systemic or local infection (contraindicated for pump implantation) * Have history/evidence of an active disruptive psychiatric disorder or other known condition with potential to impact compliance with study visits and assessments
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Comparing the efficacy of Intracthecal Baclofen dose between the Prometra II and Medtronic SynchroMed II for patients with spasticity and with current a current SyncroMed II pump needing replacement.
Papers
Results
Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.Results
Lewis KS, Mueller WM. Intrathecal baclofen for severe spasticity secondary to spinal cord injury. Ann Pharmacother. 1993 Jun;27(6):767-74. doi: 10.1177/106002809302700618.Results
Ivanhoe CB, Francisco GE, McGuire JR, Subramanian T, Grissom SP. Intrathecal baclofen management of poststroke spastic hypertonia: implications for function and quality of life. Arch Phys Med Rehabil. 2006 Nov;87(11):1509-15. doi: 10.1016/j.apmr.2006.08.323.Results
Saulino M, Ivanhoe CB, McGuire JR, Ridley B, Shilt JS, Boster AL. Best Practices for Intrathecal Baclofen Therapy: Patient Selection. Neuromodulation. 2016 Aug;19(6):607-15. doi: 10.1111/ner.12447. Epub 2016 Jul 19.Results
Middel B, Kuipers-Upmeijer H, Bouma J, Staal M, Oenema D, Postma T, Terpstra S, Stewart R. Effect of intrathecal baclofen delivered by an implanted programmable pump on health related quality of life in patients with severe spasticity. J Neurol Neurosurg Psychiatry. 1997 Aug;63(2):204-9. doi: 10.1136/jnnp.63.2.204.Results
Albright AL, Gilmartin R, Swift D, Krach LE, Ivanhoe CB, McLaughlin JF. Long-term intrathecal baclofen therapy for severe spasticity of cerebral origin. J Neurosurg. 2003 Feb;98(2):291-5. doi: 10.3171/jns.2003.98.2.0291.Background
Ordia JI, Fischer E, Adamski E, Chagnon KG, Spatz EL. Continuous intrathecal baclofen infusion by a programmable pump in 131 consecutive patients with severe spasticity of spinal origin. Neuromodulation. 2002 Jan;5(1):16-24. doi: 10.1046/j.1525-1403.2002._2004.x.
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History
Started
Sept 2020
Main results due
Dec 2022
Finished
Jun 2023