StrokePhase 1NCT00170703
Assessment of Cortical Stimulation Combined With Rehabilitation to Enhance Recovery in Broca's Aphasia.
A Phase 1 study testing Cortical Electrical Stimulation in people with Stroke and Broca's Aphasia, run by Northstar Neuroscience at 2 sites in United States.
Trial summary
The primary objective of this feasibility study is to evaluate the safety and effectiveness of targeted sub-threshold epidural cortical stimulation delivered concurrent with speech-language rehabilitation activities to enhance recovery in study subjects suffering from Broca's aphasia (the inability to speak or to… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stroke, Broca's Aphasia
- What is being tested?
- Cortical Electrical Stimulation
- Type of treatment
- Medical device
- How many people
- 8 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2004to Sep 2007
- Phase
- Phase 1
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have an ischemic stroke.
- Subjects must have a language dominant left hemisphere.
- Subjects must be diagnosed as having predominantly Broca's aphasia.
- Age 21 years or older.
Who cannot join
- Primary hemorrhagic stroke.
- Any additional stroke associated with incomplete speech recovery.
- Any neurologic or physical condition that impairs speech function.
- History of seizure disorder.
- Global aphasia or inability to participate in routine speech therapy.
- Untreated or inadequately treated depression.
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- History of traumatic brain injury, or spontaneous subdural or epidural hematoma that has resulted in a fixed (stable) speech-language deficit.
- Major active psychiatric illness that may interfere with required study procedures.
- Contraindication to magnetic resonance (MR) imaging.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rehabilitation Institute of Chicago
Chicago, Illinois, 60611
Univ. of Chicago
Chicago, Illinois, 60637
About this study
Official title: Assessment of the Safety and Effectiveness of Targeted Sub-Threshold Epidural Cortical Stimulation Delivered Concurrent With Speech-Language Rehabilitation to Enhance Recovery in Patients Suffering From Broca's Aphasia, Following a Stroke.
The primary objective of this feasibility study is to evaluate the safety and effectiveness of targeted sub-threshold epidural cortical stimulation delivered concurrent with speech-language rehabilitation activities to enhance recovery in study subjects suffering from Broca's aphasia (the inability to speak or to organize the muscular movements for speech), following a stroke.
Read the detailed description
Stroke is the third leading cause of death and the most common cause of disability in the United States. According to the American Stroke Association, the prevalence of stroke in the U.S. is approximately 4.8 million with approximately 700,000 additional strokes occurring annually. Approximately 150,000 to 250,000 stroke survivors becoming severely and permanently disabled each year.
A common neurological deficit among these stroke survivors, and thus a substantial contributor to post-stroke disability is Broca's aphasia, a condition in which the patient is unable to speak normally, as they cannot effectively organize the muscular movements required for speech. Broca's aphasia is often referred to as "non-fluent" or "motor" aphasia as essentially the patient has impaired motor abilities for speech and thus, become non-fluent in speech/language. The loss of speech for these patients is extremely debilitating and has enormous social and economic impact to the quality of life for these patients. Presently, the only treatment available for patients with Broca's aphasia is speech-language rehabilitation. However, with rehabilitation only, many patients achieve a less than satisfactory improvement in speech-language function and thus, are left with significant disability.
Since Broca's aphasia is largely due to an impairment of language-related motor function, researchers and clinicians believe it is very likely that cortical stimulation in conjunction with speech rehabilitation may also enhance recovery of language motor function for Broca's aphasia patients. This study proposes to evaluate the safety and effectiveness of such cortical electrical stimulation in study subjects with Broca's aphasia after stroke, delivered concurrent with speech-language rehabilitation.
In addition to evaluating changes from baseline level, safety and efficacy measures will be compared to patients who undergo the same speech-language rehabilitation activities but without cortical stimulation. The two study groups will be compared to determine the degree to which the aphasia can be improved beyond rehabilitation alone by epidural stimulation of a targeted cortical region.
- Conditions
- Stroke, Broca's Aphasia
- Being tested
- Cortical Electrical Stimulation
- Keywords
- Cortical Electrical Stimulation, Ischemic Stroke, Broca's Aphasia, Speech Rehabilitation, Functional MRI
- Medical subject headings
- Stroke, Aphasia, Broca, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cortical Electrical StimulationDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Aphasia Quotient on the Western Aphasia Battery (WAB-AQ) at follow-up week 1
Measures of speech rate obtained from Language Sample Analysis at follow-up week 1
Secondary outcomes (3)
Serious Adverse Event rate at follow-up weeks 1, 6 & 12-week
Aphasia Quotient on the Western Aphasia Battery (WAB-AQ) at follow-up weeks 6 & 12
Measures of speech rate obtained from Language Sample Analysis at follow-up weeks 6 & 12
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 startDec 2004
- Study completionSep 2007
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 StrokeStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 8 participants
Sponsor and investigators
- Lead sponsor
- Northstar Neuroscience
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00170703
- Sponsor's protocol ID
- V0325
- Status last verified
- Sep 2007
- First submitted
- 12 Sep 2005
- Last updated
- 21 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Cherney LR. Epidural Cortical Stimulation as Adjunctive Treatment for Nonfluent Aphasia: Phase 1 Clinical Trial Follow-up Findings. Neurorehabil Neural Repair. 2016 Feb;30(2):131-42. doi: 10.1177/1545968315622574. Epub 2015 Dec 23.
PubMed 26704258
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Safety and Effectiveness of Targeted Sub-Threshold Epidural Cortical Stimulation Delivered Concurrent With Speech-Language Rehabilitation to Enhance Recovery in Patients Suffering From Broca's Aphasia, Following a Stroke.
- ClinicalTrials.gov ID
- NCT00170703
- Acronym / sponsor ID
- V0325
- Conditions
- Stroke, Broca's Aphasia
- Keywords
- Cortical Electrical Stimulation, Ischemic Stroke, Broca's Aphasia, Speech Rehabilitation, Functional MRI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants
- Lead sponsor
- Northstar NeuroscienceIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Study completion
- Sep 2007 (actual)
- 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.
The primary objective of this feasibility study is to evaluate the safety and effectiveness of targeted sub-threshold epidural cortical stimulation delivered concurrent with speech-language rehabilitation activities to enhance recovery in study subjects suffering from Broca's aphasia (the inability to speak or to organize the muscular movements for speech), following a stroke.
Detailed description
Stroke is the third leading cause of death and the most common cause of disability in the United States. According to the American Stroke Association, the prevalence of stroke in the U.S. is approximately 4.8 million with approximately 700,000 additional strokes occurring annually. Approximately 150,000 to 250,000 stroke survivors becoming severely and permanently disabled each year.
A common neurological deficit among these stroke survivors, and thus a substantial contributor to post-stroke disability is Broca's aphasia, a condition in which the patient is unable to speak normally, as they cannot effectively organize the muscular movements required for speech. Broca's aphasia is often referred to as "non-fluent" or "motor" aphasia as essentially the patient has impaired motor abilities for speech and thus, become non-fluent in speech/language. The loss of speech for these patients is extremely debilitating and has enormous social and economic impact to the quality of life for these patients. Presently, the only treatment available for patients with Broca's aphasia is speech-language rehabilitation. However, with rehabilitation only, many patients achieve a less than satisfactory improvement in speech-language function and thus, are left with significant disability.
Since Broca's aphasia is largely due to an impairment of language-related motor function, researchers and clinicians believe it is very likely that cortical stimulation in conjunction with speech rehabilitation may also enhance recovery of language motor function for Broca's aphasia patients. This study proposes to evaluate the safety and effectiveness of such cortical electrical stimulation in study subjects with Broca's aphasia after stroke, delivered concurrent with speech-language rehabilitation.
In addition to evaluating changes from baseline level, safety and efficacy measures will be compared to patients who undergo the same speech-language rehabilitation activities but without cortical stimulation. The two study groups will be compared to determine the degree to which the aphasia can be improved beyond rehabilitation alone by epidural stimulation of a targeted cortical region.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects must have an ischemic stroke.
- Subjects must have a language dominant left hemisphere.
- Subjects must be diagnosed as having predominantly Broca's aphasia.
- Age 21 years or older.
Key exclusion criteria (9 listed)
- Primary hemorrhagic stroke.
- Any additional stroke associated with incomplete speech recovery.
- Any neurologic or physical condition that impairs speech function.
- History of seizure disorder.
- Global aphasia or inability to participate in routine speech therapy.
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 |
|---|---|---|
| Cortical Electrical Stimulation | Device | – |
Primary outcome
Aphasia Quotient on the Western Aphasia Battery (WAB-AQ) at follow-up week 1
Measures of speech rate obtained from Language Sample Analysis at follow-up week 1
3 secondary outcomes
Serious Adverse Event rate at follow-up weeks 1, 6 & 12-week
Aphasia Quotient on the Western Aphasia Battery (WAB-AQ) at follow-up weeks 6 & 12
Measures of speech rate obtained from Language Sample Analysis at follow-up weeks 6 & 12
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 21 Sep 2007.
- Derived from this study: PubMed 26704258Cherney LR. Epidural Cortical Stimulation as Adjunctive Treatment for Nonfluent Aphasia: Phase 1 Clinical Trial Follow-up Findings. Neurorehabil Neural Repair. 2016 Feb;30(2):131-42. doi: 10.1177/1545968315622574. Epub 2015 Dec 23.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cortical Electrical Stimulation in people with Stroke and Broca's Aphasia, run by Northstar Neuroscience 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 9 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 21 Sep 2007. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Aphasia Quotient on the Western Aphasia Battery (WAB-AQ) at follow-up week 1. 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?
On the ClinicalTrials.gov record for NCT00170703, 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 21 Sep 2007.