SpasticityPhase 4NCT00179114
Vanderbilt University Spasticity Management Program Evaluation Plan
A Phase 4 study testing Botulinum Toxin Type A and Intrathecal baclofen administered by the Medtronic SyncroMed(TM) pump (ITB) in people with Spasticity, run by Vanderbilt University at 1 site in United States.
Trial summary
People with severe developmental disabilities frequently have comorbidities that make providing care to them more difficult. Spasticity is one such comorbidity. It produces increased muscle tone that can cause stiffness in joints and bodily contortions that can interfere with all of the major types of care provided to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spasticity
- What is being tested?
- Botulinum Toxin Type A and Intrathecal baclofen administered by the Medtronic SyncroMed(TM) pump (ITB)
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2002to Feb 2006
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult with spasticity residing at Clover Bottom Developmental Center in Nashville, Tennessee.
- Spasticity must interfere with daily functioning.
- Care team must be able to identify at least one treatment goal for the potential participant.
Who cannot join
- Family or guardian is unwilling to provide written informed consent.
- Spasticity does not interfere with patient's day-to-day care.
- Staff who provide daily care are unable to identify a clear treatment goal.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
People with severe developmental disabilities frequently have comorbidities that make providing care to them more difficult. Spasticity is one such comorbidity. It produces increased muscle tone that can cause stiffness in joints and bodily contortions that can interfere with all of the major types of care provided to participants. Typically, care areas include splinting, hygiene, dressing, transfers, positioning, ambulation, and engaging in other functional activities. Moreover, persons with spasticity often experience pain.
Typically, spasticity is managed by health care providers using a combination of the following therapies:
- Physical / occupational therapy (PT / OT)
- Oral medication
- Botox injections
- Intrathecal baclofen administered by the Medtronic SyncroMed pump (ITB)
- Orthopedic / neurological surgery
Read the detailed description
As individuals are identified as appropriate participants for the Program and consent is obtained, the care team for each person, consisting of both medical and caregiver staff, will define up to three specific care area goals and related tasks for treatment. A comprehensive spasticity management program will then be developed for the individual. Clinical and outcome assessments at baseline and at follow-up will include measures of range of motion, global spasticity according to a modified Ashworth scale, and the time and number of staff required for the task. In addition, video will be obtained of caregivers performing each participant's care area tasks at baseline and follow-up to allow an independent external reviewer to judge task difficulty. Treatment will be provided as outlined by the spasticity management plan. Follow-up evaluations will be conducted when the participant is at least one year from their initial Botulinum injection, or are one year post-implant for ITB participants. When the participant is exited from the study, Survey Physician will be asked to rate the overall impact of the Program on each of the individual's care area tasks.
- Conditions
- Spasticity
- Being tested
- Botulinum Toxin Type A, Intrathecal baclofen administered by the Medtronic SyncroMed(TM) pump (ITB)
- Keywords
- Spasticity, Developmental Disabilities, Intrathecal baclofen (ITB), Botulinum Toxin Type A (Botox)
- Medical subject headings
- Muscle Spasticity, Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin Type ADrug
Intrathecal baclofen administered by the Medtronic SyncroMed(TM) pump (ITB)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Total time (in seconds) spent by caregivers to complete a defined care area task at one year followup.
Categorical rating by blinded, independent reviewer of baseline and one-year care area task videos.
Secondary outcomes (4)
Range of motion score for each care area goal, assigned by physical therapist and compared at baseline vs. one-year followup.
Differences in the number of hospital admissions 12 months pre- and 12 months post-program.
Differences in costs associated with caregiving 12 months pre- and 12 months post-treatment.
Difference in Physician's global assessment of spasticity at baseline and one-year followup.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startAug 2002
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpasticityStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan, Medtronic
- Investigators
- David Charles, MD, Principal investigator, Vanderbilt University Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00179114
- Sponsor's protocol ID
- SMPEP-9.1
- Status last verified
- Aug 2007
- First submitted
- 13 Sep 2005
- Last updated
- 20 Aug 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vanderbilt University Spasticity Management Program Evaluation Plan
- ClinicalTrials.gov ID
- NCT00179114
- Acronym / sponsor ID
- SMPEP-9.1
- Conditions
- Spasticity
- Keywords
- Spasticity, Developmental Disabilities, Intrathecal baclofen (ITB), Botulinum Toxin Type A (Botox)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- Allergan, Medtronic
- Study start
- Aug 2002
- Study completion
- Feb 2006
- First posted
- 15 Sep 2005 (estimated)
- 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.
People with severe developmental disabilities frequently have comorbidities that make providing care to them more difficult. Spasticity is one such comorbidity. It produces increased muscle tone that can cause stiffness in joints and bodily contortions that can interfere with all of the major types of care provided to participants. Typically, care areas include splinting, hygiene, dressing, transfers, positioning, ambulation, and engaging in other functional activities. Moreover, persons with spasticity often experience pain.
Typically, spasticity is managed by health care providers using a combination of the following therapies:
- Physical / occupational therapy (PT / OT)
- Oral medication
- Botox injections
- Intrathecal baclofen administered by the Medtronic SyncroMed pump (ITB)
- Orthopedic / neurological surgery
Detailed description
As individuals are identified as appropriate participants for the Program and consent is obtained, the care team for each person, consisting of both medical and caregiver staff, will define up to three specific care area goals and related tasks for treatment. A comprehensive spasticity management program will then be developed for the individual. Clinical and outcome assessments at baseline and at follow-up will include measures of range of motion, global spasticity according to a modified Ashworth scale, and the time and number of staff required for the task. In addition, video will be obtained of caregivers performing each participant's care area tasks at baseline and follow-up to allow an independent external reviewer to judge task difficulty. Treatment will be provided as outlined by the spasticity management plan. Follow-up evaluations will be conducted when the participant is at least one year from their initial Botulinum injection, or are one year post-implant for ITB participants. When the participant is exited from the study, Survey Physician will be asked to rate the overall impact of the Program on each of the individual's care area tasks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult with spasticity residing at Clover Bottom Developmental Center in Nashville, Tennessee.
- Spasticity must interfere with daily functioning.
- Care team must be able to identify at least one treatment goal for the potential participant.
Key exclusion criteria (3 listed)
- Family or guardian is unwilling to provide written informed consent.
- Spasticity does not interfere with patient's day-to-day care.
- Staff who provide daily care are unable to identify a clear treatment goal.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum Toxin Type A | Drug | – |
| Intrathecal baclofen administered by the Medtronic SyncroMed(TM) pump (ITB) | Drug | – |
Primary outcome
Total time (in seconds) spent by caregivers to complete a defined care area task at one year followup.
Categorical rating by blinded, independent reviewer of baseline and one-year care area task videos.
4 secondary outcomes
Range of motion score for each care area goal, assigned by physical therapist and compared at baseline vs. one-year followup.
Differences in the number of hospital admissions 12 months pre- and 12 months post-program.
Differences in costs associated with caregiving 12 months pre- and 12 months post-treatment.
Difference in Physician's global assessment of spasticity at baseline and one-year followup.
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 20 Aug 2007.
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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.
David Charles, MD principal investigator
Vanderbilt University Department of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Botulinum Toxin Type A and Intrathecal baclofen administered by the Medtronic SyncroMed(TM) pump (ITB) in people with Spasticity, run by Vanderbilt University at 1 site in United States.
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 3 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 20 Aug 2007. 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 States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Total time (in seconds) spent by caregivers to complete a defined care area task at one year followup.. The study lists 2 primary outcomes in all. 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 20 Aug 2007.