StrokeReIMageNCT07639632
Reduce Inefficiencies in Management of Spasticity
A study testing Screener in people with Stroke, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of a spasticity screener and to determine if the spasticity screener results are useful to healthcare providers and impact clinical decision making Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Screener
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2026to 30 Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Currently admitted for an acute hemorrhagic or ischemic stroke; recurrent stroke allowed if no spasticity at baseline
- NIHSS score of > 0 on items 5 or 6 (required of at least 1 limb)
- Willingness to participate in the study for 24 months
- Able to sign consent form or availability of a legally authorized representative to sign
- Able to read/write in English
- Identified MD for follow up post hospitalization
Who cannot join
- Botulinum toxin use for any indication within the past 12 weeks
- Acute life threatening illness
- Prior limb injury or neurological diagnosis that limited movement in the now affected limb(s)
- Any terminal illness that would limit participation in study follow ups
- Known spasticity or other movement disorders that impact tone
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of Texas Health Science Center at Houston PO Box 20036
Houston, Texas, 77030
Sean I Savitz, MD, 713-500-7083, Sean.I.Savitz@uth.tmc.edu
Harriet M Sales, (713) 500-7849, harriet.mari.sales@uth.tmc.edu
About this study
The purpose of this study is to evaluate the effectiveness of a spasticity screener and to determine if the spasticity screener results are useful to healthcare providers and impact clinical decision making
- Conditions
- Stroke
- Being tested
- Screener, Standard of care
- Keywords
- acute ischemic stroke, intracerebral hemorrhage
- Medical subject headings
- Stroke, Ischemic Stroke, Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScreenerOther
Participants will be screened for spasticity using the 2 question version of the Post-stroke Spasticity Monitoring Questionnaire (PSMQ) at 2 days after discharge, 2 weeks post stroke, 1 month post stroke, 3 months post stroke and every 3 months after for a total of 12 screenings across 24 months
Standard of careOther
Observational data for the standard of care group will be obtained via phone every 3 months post stroke up to 24 months, utilizing the Standard of Care Group Questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Screener | Experimental | Not described Receives: Other: Screener |
| Standard of care | Active comparator | Not described Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to detect spasticity from incidence of stroke
Measured: From baseline to 24 months after stroke
Secondary outcomes (2)
Time to referral for spasticity from incidence of stroke
Evaluate average time to referral to neurology or Physical Medicine \& Rehabilitation (PM\&R)
Measured: From baseline to 24 months after stroke
The time from incidence of stroke to Botulinum neurotoxin (BoNT) administration
Measured: From baseline to 24 months after stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion1 Aug 2029 (estimated)
- Study completion30 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- AbbVie
- Responsible party
- Principal investigator, Sean Savitz, The University of Texas Health Science Center, Houston
- Investigators
- Sean I Savitz, MD, Principal investigator, The University of Texas Health Science Center at Houston PO Box 20036
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07639632
- Sponsor's protocol ID
- HSC-MS-26-0099
- Acronym
- ReIMage
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 12 Jun 2026
- 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 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduce Inefficiencies in Management of Spasticity
- ClinicalTrials.gov ID
- NCT07639632
- Acronym / sponsor ID
- ReIMage / HSC-MS-26-0099
- Conditions
- Stroke
- Keywords
- acute ischemic stroke, intracerebral hemorrhage
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- AbbVie
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 1 Aug 2029 (estimated)
- Study completion
- 30 Nov 2029 (estimated)
- First posted
- 10 Jun 2026 (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 purpose of this study is to evaluate the effectiveness of a spasticity screener and to determine if the spasticity screener results are useful to healthcare providers and impact clinical decision making
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Screener | Experimental | Other: Screener |
| Standard of care | Active comparator | Other: Standard of care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Currently admitted for an acute hemorrhagic or ischemic stroke; recurrent stroke allowed if no spasticity at baseline
- NIHSS score of > 0 on items 5 or 6 (required of at least 1 limb)
- Willingness to participate in the study for 24 months
- Able to sign consent form or availability of a legally authorized representative to sign
- Able to read/write in English
Key exclusion criteria (5 listed)
- Botulinum toxin use for any indication within the past 12 weeks
- Acute life threatening illness
- Prior limb injury or neurological diagnosis that limited movement in the now affected limb(s)
- Any terminal illness that would limit participation in study follow ups
- Known spasticity or other movement disorders that impact tone
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 |
|---|---|---|
| ScreenerParticipants will be screened for spasticity using the 2 question version of the Post-stroke Spasticity Monitoring Questionnaire (PSMQ) at 2 days after discharge, 2 weeks post stroke, 1 month post stroke, 3 months post stroke and every 3 months after for a total of 12 screenings across 24 months | Other | Screener |
| Standard of careObservational data for the standard of care group will be obtained via phone every 3 months post stroke up to 24 months, utilizing the Standard of Care Group Questionnaire. | Other | Standard of care |
Primary outcome
Time to detect spasticity from incidence of stroke
Time frame: From baseline to 24 months after stroke
2 secondary outcomes
Time to referral for spasticity from incidence of stroke
Time frame: From baseline to 24 months after stroke
The time from incidence of stroke to Botulinum neurotoxin (BoNT) administration
Time frame: From baseline to 24 months after stroke
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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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.
Sean I Savitz, MD principal investigator
The University of Texas Health Science Center at Houston PO Box 20036
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screener in people with Stroke, run by The University of Texas Health Science Center, Houston 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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 12 Jun 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sean I Savitz, MD ((713) 500-7083, Sean.I.Savitz@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to detect spasticity from incidence of stroke (time frame: From baseline to 24 months after stroke). 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 12 Jun 2026.