NCT03151941

Respiratory Monitoring of Intrathecal Baclofen- a Feasibility Study

A Feasibility Study Monitoring the Respiratory Status of Participants Receiving or Scheduled to Receive Intrathecal Baclofen (ITB)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 15 (actual)
• Sponsor: Solent NHS Trust · Other Government
• Sex: All
• Age: 18 Years – 110 Years
• Healthy volunteers: Not accepted

Summary

The methodology is a feasibility study to determine the feasibility of assessing people in the community with a neurological condition before proceeding towards a full powered community trial evaluating the influence of intrathecal baclofen.

Detailed description

The purpose of this proposed research will evaluate a feasible method to assess the respiratory status of people with neurological conditions receiving or scheduled to receive Intrathecal Baclofen. The use of Intrathecal Baclofen to manage severe spasticity is a developing treatment option with a limited research base, particularly when evaluating the influence of intrathecal baclofen on the respiratory system. The proposed research is derived from clinical practice and involves joint collaboration between clinical team, research professionals and patients. In order for the study to evaluate the influence of Intrathecal baclofen has on the respiratory system, the proposed research will need to develop and evaluate a method of assessing people in the community ensuring it's feasible for people with neurological conditions. Prior to implementing a full powered community trial to evaluate the influence of intrathecal baclofen on people with neurological conditions.

Conditions

• Intrathecal Baclofen
• Multiple Sclerosis
• Respiratory System
• Cerebral Palsy

Timeline

• Start date: 2017-03-06
• Primary completion: 2017-08-31
• Completion: 2017-08-31
• First posted: 2017-05-12
• Last updated: 2017-10-10

Locations

1 site across 1 country: United Kingdom