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Respiratory Monitoring of Intrathecal Baclofen- a Feasibility Study

NCT ID: NCT03151941

Last Updated: 2017-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-06

Study Completion Date

2017-08-31

Brief Summary

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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

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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

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Intrathecal Baclofen Multiple Sclerosis Respiratory System Cerebral Palsy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Solent NHS Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hayden Kirk

Role: PRINCIPAL_INVESTIGATOR

Solent NHS Trust

Locations

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Solent NHS Trust

Portsmouth, Hampshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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1

Identifier Type: -

Identifier Source: org_study_id