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

No Placebo-Only Group

Summary

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

Eligible Conditions

Muscle Spasms
Spasticity
Stroke
Multiple Sclerosis
Traumatic Brain Injury
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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Comparison of spasticity control with Synchromed II versus Prometra II

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

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