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Recruiting NCT07727798

Intrathecal Pump Refills at Home or at the Hospital

Conditions: Intrathecal Pump Refill

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 82
Sponsor: Moens Maarten

Location: UZ Brussel Jette

Summary

The IMPROVE study is a randomized, controlled, cross-over trial designed to compare intrathecal pump refills performed at home with those carried out in the hospital. Intrathecal drug delivery (IDD) is used in patients with chronic pain or severe spasticity. Use of IDD requires the performance of pump refills about 4-6 times a year which may be a burdensome and stressful experience for patients and their caregivers. Hospital visits can increase stress, pain, and caregiver strain, while early pilot studies suggest home-based refills may be both safe and more comfortable. Eighty-two adult patients in Belgium with an implanted intrathecal pump will be enrolled in the IMPROVE study. Each participant will undergo four refill procedures: two at home and two at the hospital, in randomized order.

Eligibility Criteria

Inclusion Criteria: * Actively receiving Intrathecal drug delivery * Stable medication dosage for at least 3 months * Dutch, French or English speaking adults Exclusion Criteria: * Life expectancy \< 6 months * Patients planned for but not yet received Intrathecal drug delivery implant * No residence in Belgium

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07727798). StuddyBuddy aggregates publicly available trial information.