RecruitingNot ApplicableNCT07727798

Intrathecal Pump Refills at Home or at the Hospital

Intrathecal Pump Refills at Home or at the Hospital: a Randomized Controlled Crossover Trial


Sponsor

Moens Maarten

Enrollment

82 participants

Start Date

Oct 15, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • Actively receiving Intrathecal drug delivery
  • Stable medication dosage for at least 3 months
  • Dutch, French or English speaking adults

Exclusion Criteria3

  • Life expectancy < 6 months
  • Patients planned for but not yet received Intrathecal drug delivery implant
  • No residence in Belgium

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Interventions

PROCEDURERefill at the hospital

Intrathecal pump refill procedure conducted at the hospital

PROCEDURERefill at home

Intrathecal pump refill procedure conducted at the home of the patient


Locations(1)

UZ Brussel

Jette, Belgium

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NCT07727798