Traumatic Brain Injury Clinical Trial
Official title:
Transitioning to a Valve-Gated Intrathecal Drug Delivery System (IDDS): A Randomized, Controlled, Multi-center, Prospective Study Evaluating Dose Reduction in ITB Patients.
NCT number | NCT04530955 |
Other study ID # | AT-001 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | September 24, 2020 |
Est. completion date | June 2023 |
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.
Status | Recruiting |
Enrollment | 92 |
Est. completion date | June 2023 |
Est. primary completion date | December 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 22 Years to 85 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Culicchia Neurological Clinic | Marrero | Louisiana |
Lead Sponsor | Collaborator |
---|---|
Culicchia Neurological Clinic | Flowonix Medical |
United States,
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. — View Citation
Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. — View Citation
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. — View Citation
Lewis KS, Mueller WM. Intrathecal baclofen for severe spasticity secondary to spinal cord injury. Ann Pharmacother. 1993 Jun;27(6):767-74. Review. — View Citation
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 — View Citation
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. — View Citation
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of spasticity control with Synchromed II versus Prometra II | To evaluate that a Baclofen dose reduction delivered through a valve-gated intrathecal drug delivery system (Prometra II) provides spasticity control no less than the baseline dose delivered through a peristaltic intrathecal drug delivery system (SynchroMed II). NOTE: In this study, a modified Ashworth scores will be prospectively collected for valve-gated pumps and will be compared to retrospectively collected modified Ashworth scores prior to peristaltic pump explant. |
3 months | |
Secondary | Comparison of patient report of spasm frequency with Synchromed II versus Prometra II | To evaluate change in patient self-assessment of spasticity prior to peristaltic pump explant compared to scores after conversion to a valve-gated pump. | 3 months |
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