Respiratory Monitoring of Intrathecal Baclofen- a Feasibility Study

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03151941
• Other study ID #: 1
• Status: Completed
• Phase: N/A
• First received: March 13, 2017
• Last updated: October 9, 2017
• Start date: March 6, 2017
• Est. completion date: August 31, 2017

Study information

• Verified date: October 2017
• Source: Solent NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 31, 2017
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

Inclusion Criteria:

• -Adults over the age of 18

• A person who is able to provide consent or a family member/ close friend who is able to assent on behalf of the participant

• A person or a family member/ close friend who is able to understand English (understand written English and spoken instructions)

• A person currently receiving Intrathecal Baclofen or is scheduled to receive Intrathecal Baclofen (awaiting fitting of pump) therapy to manage spasticity

• A patient of the Solent/ University Hospitals Southampton NHS Foundation Trust Intrathecal baclofen service

Exclusion Criteria:

• -Pre-existing use of overnight non-invasive ventilation (NIV) and is compliant with NIV treatment

• A person who is unable to consent to the study and does not have a family/ close person to assent

• The study will exclude a person who is unable to independently remove the polysomnography and is also without supervision from another person (carer or partner) during the night. This ensures the participant is able to take off the polysomnography (or assisted by a carer) if it becomes uncomfortable and/or causes distress.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United Kingdom	Solent NHS Trust	Portsmouth	Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Solent NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overnight home polysomnography	sleep study	2 nights
Secondary	Sniff nasal inspiratory pressure Expiratory and inspiratory mouth pressures Cough peak flow Expanded disability status scale Epworth sleepiness scale Semi Structured interview	Sniff nasal inspiratory pressure Expiratory and inspiratory mouth pressures Cough peak flow Expanded disability status scale Epworth sleepiness scale Semi Structured interview	2 nights