Recruiting

IDDS

Sponsor:

Culicchia Neurological Clinic

Code:

NCT04530955

Conditions

Injuries, Spinal Cord

CVA (Cerebrovascular Accident)

Traumatic Brain Injury

MS (Multiple Sclerosis)

Muscle Spasticity

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Accepted

Interventions

Prometra II Programmable Pump - Flowonix Medical

Study Details

Brief summary:

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.

Conditions

Injuries, Spinal Cord

CVA (Cerebrovascular Accident)

Traumatic Brain Injury

MS (Multiple Sclerosis)

Muscle Spasticity

Study ID

NCT04530955

Start date

Sep 24, 2020

Status verified date

Sep, 2020

Completion date

Jun, 2023

Anticipated

Primary completion date

Dec, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

92 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Control Arm

Patients randomized to the Control Arm that have been implanted with the valve-gated pump will be started on an equivalent dose (without change to the medication concentration) as prior to implant. If at any time during the patients' treatment it is determined by the investigator that the patients' treatment dose needs to be modified, the dose can be modified as clinically indicated. Multiple dosing decreases may be performed if the patient is clinically demonstrating a reduction in spasticity that is profound and negatively impacting function, or if the patient is demonstrating signs of baclofen overdose.

The criteria for dosing decrease will be clinical discretion.

active comparator: Study Arm

Patients randomized to the Study Arm will be started on a 20% dose reduction (without change to the medication concentration) through the newly implanted valve-gated pump. If at any time during the patients' treatment it is determined by the investigator that the patients' treatment dose needs to be increased or decreased, the dose can be increased/decreased as clinically indicated. If the dose increases with the valve-gated pump reach the patients' baseline dose and the patient's spasticity is worse than his or her spasticity at baseline, then the patient will be considered a primary endpoint failure.

The criteria for dosing increase will be clinical discretion.

Interventions

Prometra II Programmable Pump - Flowonix Medical

The valve gated Prometra II Programmable Pump will be replacing the prior peristaltic Synchromed II pump and a 20% dose decrease will be performed at the time of the replacement.

Primary outcome measure

  • Comparison of spasticity control with Synchromed II versus Prometra II [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Cassi Bodenheimer, RN

504-340-6976cbodenheimer@culicchianeuro.com

Janet Smith

832-612-6326busyproconsulting@gmail.com

Locations

Culicchia Neurological Clinic

Recruiting

Marrero, Louisiana, United States, 70072

Contacts

Cassi Bodenheimer, RN

504-340-6976cbodenheimer@culicchianeuro.com

Principal Investigator:

Andrea Toomer, MD

More Information

Sponsor

Culicchia Neurological Clinic

Last update posted

Sep 28, 2020

Last verified

Sep, 2020

Keywords

  • Spasticity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-07. This information was provided to ClinicalTrials.gov by Culicchia Neurological Clinic on 2020-09-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.