Transitioning to a Valve-Gated Intrathecal Drug Delivery System (IDDS)

Status unconfirmed · Not applicable

Conditions studied: Injuries, Spinal Cord, CVA (Cerebrovascular Accident), Traumatic Brain Injury, MS (Multiple Sclerosis), Muscle Spasticity, Cerebral Palsy, Spastic

In brief

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.

Key facts

Study ID: NCT04530955
Run by: Culicchia Neurological Clinic
People needed: 92
Starts: 2020-09-24
Expected to finish: 2023-06-01
Last updated by the study team: 2020-09-28

Who can join

Age: 22 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Culicchia Neurological Clinic — Marrero, Louisiana, United States (enrolling)

Full record on ClinicalTrials.gov

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