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Programmable Pump

Study Arm for Muscle Spasms

N/A

Waitlist Available

Led By Andrea Toomer, MD

Research Sponsored by Culicchia Neurological Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

Study Summary

This trial is comparing two different types of pumps for patients with spasticity.

Eligible Conditions

Muscle Spasms
Multiple Sclerosis
Traumatic Brain Injury
Stroke
Spinal Cord Injury
Cerebral Palsy

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Comparison of spasticity control with Synchromed II versus Prometra II

Secondary outcome measures

Comparison of patient report of spasm frequency with Synchromed II versus Prometra II

Trial Design

2Treatment groups

Active Control

Group I: Control ArmActive Control1 Intervention

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.

Group II: Study ArmActive Control1 Intervention

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Culicchia Neurological ClinicLead Sponsor

Flowonix MedicalIndustry Sponsor

8 Previous Clinical Trials

703 Total Patients Enrolled

Andrea Toomer, MD3.311 ReviewsPrincipal Investigator - Culicchia Neurological Clinic Partner

Culicchia Neurological Clinic

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an upper age limit to participation in this trial?

"The criteria for this clinical trial necessitates that patients are between the ages of 22 and 85. For those under 18, there are 356 studies available, while 2074 exist for people above 65 years old."

Answered by AI

Are there still open slots available to participate in this experiment?

"According to the details available on clinicaltrials.gov, this trial is in pursuit of participants as of September 24th 2020 and has been active since its initial posting date."

Answered by AI

How many candidates are eligible to join this clinical experiment?

"Affirmative. Data available on clinicaltrials.gov suggests that this medical study, first posted on September 24th 2020, is actively recruiting patients. 92 participants need to be enrolled across a single site."

Answered by AI

Do I fulfill the criteria for participation in this experiment?

"This trial, which seeks 92 participants suffering from multiple sclerosis and between 22 and 85 years old, has several prerequisites. These include a modified Ashworth score acquired in the three months before implantation of the valve-gated pump, surgical candidacy, drug dosage stability for 3 or more months prior to implantation, gender (male/female), as well as being an existing ITB patient with any form of spasticity."

Answered by AI