StrokePhase 3EVERESTNCT00170716
Safety and Effectiveness of Cortical Stimulation in the Treatment of Stroke Patients With Upper Extremity Hemiparesis
A Phase 3 study testing Cortical Stimulation and rehabilitation and Rehabilitation in people with Stroke and Hemiparesis, run by Northstar Neuroscience at 21 sites in United States.
Trial summary
The purpose of this study is to assess the safety and effectiveness of cortical stimulation delivered concurrent with rehabilitation activities to enhance motor recovery in patients suffering from hemiparesis affecting the upper extremity following a stroke. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stroke, Hemiparesis
- What is being tested?
- Cortical Stimulation and rehabilitation and Rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 21 sitesUnited States
- Study dates
- Sep 2004to Mar 2008
- Phase
- Phase 3
- 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.
- Moderate to moderately severe upper-extremity hemiparesis.
- Aged 21 years or older.
Who cannot join
- Primary hemorrhagic stroke.
- Any additional stroke associated with incomplete motor recovery.
- Any neurologic or physical condition impairing function of the target extremity.
- History of seizure disorder.
- History of spinal cord injury, traumatic brain injury, or spontaneous subdural or epidural hematoma that has resulted in a neurologic deficit.
- Contraindication to magnetic resonance (MR) imaging.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Emory Clinic
Atlanta, Georgia, 30322
Spaulding Rehabilitation Center and Massachusetts General Hospital
Boston, Massachusetts, 02114
Northwestern University Medical Center and the Rehabilitation Institute of Chicago
Chicago, Illinois, 60611
University of Illinois at Chicago
Chicago, Illinois, 60612
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267
Wayne State University
Detroit, Michigan, 48201
Colorado Neurological Institute & Swedish Medical Center
Englewood, Colorado, 80113
University of Texas Health Sciences Center at Houston
Houston, Texas, 77030
University of Florida, Jacksonville
Jacksonville, Florida, 32209-6511
St. Luke's Hospital
Kansas City, Missouri, 64111
University of Southern California
Los Angeles, California, 90089
Mount Sinai School of Medicine
New York, New York, 10029
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Oregon Health Sciences University
Portland, Oregon, 97201
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132
University of California San Francisco Medical Center
San Francisco, California, 94125
Swedish Health Services
Seattle, Washington, 98122
Stanford University Medical Center
Stanford, California, 94305
State University of New York Upstate Medical Center
Syracuse, New York, 13210
University of Arizona Health Sciences Center
Tucson, Arizona, 85724
About this study
Official title: Safety and Effectiveness of Targeted Sub-Threshold Epidural Cortical Stimulation Delivered Concurrent With Rehabilitation Activities to Enhance Motor Recovery in Patients Suffering From Upper Extremity Hemiparesis Following a Stroke
The purpose of this study is to assess the safety and effectiveness of cortical stimulation delivered concurrent with rehabilitation activities to enhance motor recovery in patients suffering from hemiparesis affecting the upper extremity following a stroke.
Read the detailed description
Stroke is a leading cause of serious, long-term 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. The 2001 overall death rate for stroke was 58%. Of those who survive, 30 to 50 percent do not regain functional independence, 15 to 30 percent are permanently disabled, and 20% require institutional care at three months after onset.
The most common neurological deficit among these stroke survivors, and thus a substantial contributor to post-stroke disability, is a motor weakness on one (hemiparesis) side of the body. Presently, the only treatment available for patients with motor deficits is rehabilitative therapy. However, many patients are not responsive to standard rehabilitative therapy or achieve a less than satisfactory improvement in function.
The primary objective of this study is to determine the safety and effectiveness of targeted sub-threshold epidural cortical stimulation delivered concurrent with rehabilitation activities to enhance motor recovery in patients suffering from hemiparesis (a motor weakness in one half of the body) affecting the upper extremity (shoulder, arm, wrist, hand) following a stroke. In addition to evaluating changes from baseline level, safety and efficacy measures will be compared to patients who undergo the same rehabilitation activities but without cortical stimulation. The two study groups will be compared to determine the degree to which motor function of the affected limb can be improved beyond rehabilitation alone by epidural stimulation of a targeted cortical region.
- Conditions
- Stroke, Hemiparesis
- Being tested
- Cortical Stimulation and rehabilitation, Rehabilitation
- Keywords
- Motor Cortex Electrical Stimulation, Ischemic Stroke, Upper Extremity Hemiparesis, Rehabilitation, Motor Recovery, Functional MRI
- Medical subject headings
- Stroke, Paresis, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cortical Stimulation and rehabilitationDevice
Also called Renova-ST Cortical Stimulation System
Cortical stimulation is provided concomitantly with rehabilitation therapy. Rehabilitation is for 2.5 hrs per day for 26 days over a period of 6 weeks.
RehabilitationOther
Also called Post-stroke rehabilitation.
Rehabilitation is for 2.5 hrs per day for 26 days over a period of 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Not described Receives: Other: Rehabilitation |
| Investigational | Experimental | Not described Receives: Device: Cortical Stimulation and rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arm Motor Fugl-Meyer (AMFM) score
Measured: Follow Up Week 4
Arm Motor Ability Test (AMAT) score
Measured: Follow Up Week 4
Secondary outcomes (3)
Box and Block Test score
Measured: Follow Up Week 4
Stroke Specific Quality of Life (SSQOL) score
Measured: Follow Up Week 4
Serious adverse event rate
Measured: Follow up week 4 and 6 months
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 startSep 2004
- Study completionMar 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northstar Neuroscience
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00170716
- Sponsor's protocol ID
- V0267
- Acronym
- EVEREST
- Status last verified
- Dec 2007
- First submitted
- 9 Sep 2005
- Last updated
- 28 Dec 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Brown JA, Lutsep H, Cramer SC, Weinand M. Motor cortex stimulation for enhancement of recovery after stroke: case report. Neurol Res. 2003 Dec;25(8):815-8. doi: 10.1179/016164103771953907.
PubMed 14669524Cramer SC, Benson RR, Himes DM, Burra VC, Janowsky JS, Weinand ME, Brown JA, Lutsep HL. Use of functional MRI to guide decisions in a clinical stroke trial. Stroke. 2005 May;36(5):e50-2. doi: 10.1161/01.STR.0000163109.67851.a0. Epub 2005 Apr 14.
PubMed 15831835Brown JA, Lutsep HL, Weinand M, Cramer SC. Motor cortex stimulation for the enhancement of recovery from stroke: a prospective, multicenter safety study. Neurosurgery. 2006 Mar;58(3):464-73. doi: 10.1227/01.NEU.0000197100.63931.04.
PubMed 16528186Levy RM, Harvey RL, Kissela BM, Winstein CJ, Lutsep HL, Parrish TB, Cramer SC, Venkatesan L. Epidural Electrical Stimulation for Stroke Rehabilitation: Results of the Prospective, Multicenter, Randomized, Single-Blinded Everest Trial. Neurorehabil Neural Repair. 2016 Feb;30(2):107-19. doi: 10.1177/1545968315575613. Epub 2015 Mar 6.
PubMed 25748452
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Targeted Sub-Threshold Epidural Cortical Stimulation Delivered Concurrent With Rehabilitation Activities to Enhance Motor Recovery in Patients Suffering From Upper Extremity Hemiparesis Following a Stroke
- ClinicalTrials.gov ID
- NCT00170716
- Acronym / sponsor ID
- EVEREST / V0267
- Conditions
- Stroke, Hemiparesis
- Keywords
- Motor Cortex Electrical Stimulation, Ischemic Stroke, Upper Extremity Hemiparesis, Rehabilitation, Motor Recovery, Functional MRI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Northstar NeuroscienceIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Study completion
- Mar 2008 (estimated)
- 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 purpose of this study is to assess the safety and effectiveness of cortical stimulation delivered concurrent with rehabilitation activities to enhance motor recovery in patients suffering from hemiparesis affecting the upper extremity following a stroke.
Detailed description
Stroke is a leading cause of serious, long-term 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. The 2001 overall death rate for stroke was 58%. Of those who survive, 30 to 50 percent do not regain functional independence, 15 to 30 percent are permanently disabled, and 20% require institutional care at three months after onset.
The most common neurological deficit among these stroke survivors, and thus a substantial contributor to post-stroke disability, is a motor weakness on one (hemiparesis) side of the body. Presently, the only treatment available for patients with motor deficits is rehabilitative therapy. However, many patients are not responsive to standard rehabilitative therapy or achieve a less than satisfactory improvement in function.
The primary objective of this study is to determine the safety and effectiveness of targeted sub-threshold epidural cortical stimulation delivered concurrent with rehabilitation activities to enhance motor recovery in patients suffering from hemiparesis (a motor weakness in one half of the body) affecting the upper extremity (shoulder, arm, wrist, hand) following a stroke. In addition to evaluating changes from baseline level, safety and efficacy measures will be compared to patients who undergo the same rehabilitation activities but without cortical stimulation. The two study groups will be compared to determine the degree to which motor function of the affected limb 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 (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Rehabilitation |
| Investigational | Experimental | Device: Cortical Stimulation and rehabilitation |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects must have an ischemic stroke.
- Moderate to moderately severe upper-extremity hemiparesis.
- Aged 21 years or older.
Key exclusion criteria (6 listed)
- Primary hemorrhagic stroke.
- Any additional stroke associated with incomplete motor recovery.
- Any neurologic or physical condition impairing function of the target extremity.
- History of seizure disorder.
- History of spinal cord injury, traumatic brain injury, or spontaneous subdural or epidural hematoma that has resulted in a neurologic deficit.
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 Stimulation and rehabilitationAlso: Renova-ST Cortical Stimulation SystemCortical stimulation is provided concomitantly with rehabilitation therapy. Rehabilitation is for 2.5 hrs per day for 26 days over a period of 6 weeks. | Device | Investigational |
| RehabilitationAlso: Post-stroke rehabilitation.Rehabilitation is for 2.5 hrs per day for 26 days over a period of 6 weeks. | Other | Control |
Primary outcome
Arm Motor Fugl-Meyer (AMFM) score
Time frame: Follow Up Week 4
Arm Motor Ability Test (AMAT) score
Time frame: Follow Up Week 4
3 secondary outcomes
Box and Block Test score
Time frame: Follow Up Week 4
Stroke Specific Quality of Life (SSQOL) score
Time frame: Follow Up Week 4
Serious adverse event rate
Time frame: Follow up week 4 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2007.
- Background: PubMed 14669524Brown JA, Lutsep H, Cramer SC, Weinand M. Motor cortex stimulation for enhancement of recovery after stroke: case report. Neurol Res. 2003 Dec;25(8):815-8. doi: 10.1179/016164103771953907.
- Background: PubMed 15831835Cramer SC, Benson RR, Himes DM, Burra VC, Janowsky JS, Weinand ME, Brown JA, Lutsep HL. Use of functional MRI to guide decisions in a clinical stroke trial. Stroke. 2005 May;36(5):e50-2. doi: 10.1161/01.STR.0000163109.67851.a0. Epub 2005 Apr 14.
- Background: PubMed 16528186Brown JA, Lutsep HL, Weinand M, Cramer SC. Motor cortex stimulation for the enhancement of recovery from stroke: a prospective, multicenter safety study. Neurosurgery. 2006 Mar;58(3):464-73. doi: 10.1227/01.NEU.0000197100.63931.04.
- Derived from this study: PubMed 25748452Levy RM, Harvey RL, Kissela BM, Winstein CJ, Lutsep HL, Parrish TB, Cramer SC, Venkatesan L. Epidural Electrical Stimulation for Stroke Rehabilitation: Results of the Prospective, Multicenter, Randomized, Single-Blinded Everest Trial. Neurorehabil Neural Repair. 2016 Feb;30(2):107-19. doi: 10.1177/1545968315575613. Epub 2015 Mar 6.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cortical Stimulation and rehabilitation and Rehabilitation in people with Stroke and Hemiparesis, run by Northstar Neuroscience at 21 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 28 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Arm Motor Fugl-Meyer (AMFM) score (time frame: Follow Up Week 4). 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 NCT00170716, which also lists 4 linked publications.
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 28 Dec 2007.