Intrathecal BaclofenNCT03151941
Respiratory Monitoring of Intrathecal Baclofen- a Feasibility Study
An observational study of Intrathecal Baclofen and Multiple Sclerosis, run by Solent NHS Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Intrathecal Baclofen, Multiple Sclerosis, Respiratory System
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Mar 2017to 31 Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with Neurological conditions receiving or scheduled to receive intrathecal baclofen therapy.
Who may be able to join
- -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
Who cannot join
- -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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Study Monitoring the Respiratory Status of Participants Receiving or Scheduled to Receive Intrathecal Baclofen (ITB)
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.
Read the 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.
- Medical subject headings
- Multiple Sclerosis, Cerebral Palsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Overnight home polysomnography
sleep study
Measured: 2 nights
Secondary outcomes (1)
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
Measured: 2 nights
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start6 Mar 2017
- Primary completion31 Aug 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrathecal BaclofenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solent NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hayden Kirk, Principal investigator, Solent NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03151941
- Sponsor's protocol ID
- 1
- Status last verified
- Oct 2017
- First submitted
- 13 Mar 2017
- Last updated
- 10 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study Monitoring the Respiratory Status of Participants Receiving or Scheduled to Receive Intrathecal Baclofen (ITB)
- ClinicalTrials.gov ID
- NCT03151941
- Acronym / sponsor ID
- 1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Solent NHS TrustOther government
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 12 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with Neurological conditions receiving or scheduled to receive intrathecal baclofen therapy.
Key inclusion criteria (5 listed)
- -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
Key exclusion criteria (3 listed)
- -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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overnight home polysomnography
Time frame: 2 nights
sleep study
1 secondary outcome
Sniff nasal inspiratory pressure Expiratory and inspiratory mouth pressures Cough peak flow Expanded disability status scale Epworth sleepiness scale Semi Structured interview
Time frame: 2 nights
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hayden Kirk principal investigator
Solent NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intrathecal Baclofen and Multiple Sclerosis, run by Solent NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overnight home polysomnography (time frame: 2 nights). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2017.