Ischemic StrokeNCT00713050
Speech and Language Therapy After Stroke
A study testing Imitate Therapy in people with Ischemic Stroke, run by University of Chicago at 2 sites in United States.
Trial summary
Our overall goal is to advance the state of functional brain imaging in aphasia, and then to apply the method to an intensive, imitation-based treatment for non-fluent aphasia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Imitate Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2007to Jan 2012
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Single ischemic infarction in the MCA territory involving the cerebral cortex (confirmed by CT or MRI)
- Aphasia
- Visual attention and language comprehension sufficient to perform imitation fMRI tasks
- Right handed (prior to stroke)
Who cannot join
- Exclusions to the study are people with cardiac pacemakers, claustrophobia, neurosurgical clips, or cognitive impairments too severe to permit cooperation with cognitive tasks in an MRI scanner.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Solodkin/Small Brain Circuits Laboratory
Irvine, California, 92697
University of California Irvine
Irvine, California, 92697
About this study
Official title: Neurophysiological Measurement in Aphasia Treatment
Our overall goal is to advance the state of functional brain imaging in aphasia, and then to apply the method to an intensive, imitation-based treatment for non-fluent aphasia.
Read the detailed description
Detailed information will follow in the next progress report.
- Conditions
- Ischemic Stroke
- Being tested
- Imitate Therapy
- Keywords
- stroke, aphasia, imitation, mirror neuron
- Medical subject headings
- Ischemic Stroke, Stroke, Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imitate TherapyBehavioural
Also called Imitate
Imitation-based computer therapy
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Computer-based Aphasia therapy Receives: Behavioral: Imitate Therapy |
| Control | Active comparator | Control Arm - Healthy subjects. Receives: Behavioral: Imitate Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in scores on Western Aphasia Battery
Measured: Four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2008 (estimated)
- Study startAug 2007
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: Protocol expired; PI retired
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), Shirley Ryan AbilityLab
- Responsible party
- Sponsor
- Investigators
- Steven Small, M.D., Ph.D., Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00713050
- Sponsor's protocol ID
- 13785A
- Other IDs
- 5R01DC007488-05
- Status last verified
- Jun 2013
- First submitted
- 9 Jul 2008
- Last updated
- 11 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Duncan ES, Schmah T, Small SL. Performance Variability as a Predictor of Response to Aphasia Treatment. Neurorehabil Neural Repair. 2016 Oct;30(9):876-82. doi: 10.1177/1545968316642522. Epub 2016 Apr 6.
PubMed 27053642
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiological Measurement in Aphasia Treatment
- ClinicalTrials.gov ID
- NCT00713050
- Acronym / sponsor ID
- 13785A
- Conditions
- Ischemic Stroke
- Keywords
- stroke, aphasia, imitation, mirror neuron
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Protocol expired; PI retired
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), Shirley Ryan AbilityLab
- Study start
- Aug 2007
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 11 Jul 2008 (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.
Our overall goal is to advance the state of functional brain imaging in aphasia, and then to apply the method to an intensive, imitation-based treatment for non-fluent aphasia.
Detailed description
Detailed information will follow in the next progress report.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Imitate TherapyComputer-based Aphasia therapy |
| Control | Active comparator | Behavioral: Imitate TherapyControl Arm - Healthy subjects. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Single ischemic infarction in the MCA territory involving the cerebral cortex (confirmed by CT or MRI)
- Aphasia
- Visual attention and language comprehension sufficient to perform imitation fMRI tasks
- Right handed (prior to stroke)
Key exclusion criteria (1 listed)
- Exclusions to the study are people with cardiac pacemakers, claustrophobia, neurosurgical clips, or cognitive impairments too severe to permit cooperation with cognitive tasks in an MRI scanner.
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 |
|---|---|---|
| Imitate TherapyAlso: ImitateImitation-based computer therapy | Behavioural | Control, Experimental |
Primary outcome
Changes in scores on Western Aphasia Battery
Time frame: Four months
Results and safety
The study was stopped early (reason given: Protocol expired; PI retired). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2013.
- Derived from this study: PubMed 27053642Duncan ES, Schmah T, Small SL. Performance Variability as a Predictor of Response to Aphasia Treatment. Neurorehabil Neural Repair. 2016 Oct;30(9):876-82. doi: 10.1177/1545968316642522. Epub 2016 Apr 6.
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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.
Steven Small, M.D., Ph.D. principal investigator
University of Chicago
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imitate Therapy in people with Ischemic Stroke, run by University of Chicago at 2 sites 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 4 inclusion and 1 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: stopped early, as of the sponsor's last update on 11 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study was stopped early (reason given: Protocol expired; PI retired). Results are not available in the source record.
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?
Changes in scores on Western Aphasia Battery (time frame: Four months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00713050, which also lists 1 linked publication.
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 11 Jun 2013.