Ischemic Stroke Clinical Trial
— ImpACT-24BOfficial title:
A Multicenter, Randomized, Double Blind, Sham Control, Parallel Arm Trial to Assess Effectiveness and Safety of the Ischemic Stroke System ISS, as an Adjunct to Standard of Care in Subjects With Acute Ischemic Stroke
NCT number | NCT00826059 |
Other study ID # | CLP1000500 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2011 |
Est. completion date | June 2018 |
Verified date | March 2019 |
Source | BrainsGate |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary objective of the study is to assess the safety and effectiveness of SPG stimulation with the ISS in patients with an acute ischemic stroke in the anterior circulation initiated within 24 hours from stroke onset.
Status | Completed |
Enrollment | 1078 |
Est. completion date | June 2018 |
Est. primary completion date | June 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 85 Years |
Eligibility |
Inclusion Criteria: 1. Age: Between 40 years and 80 years for male and 85 for female subjects 2. Clinical diagnosis of an acute ischemic stroke in the Carotid, Middle or Anterior Cerebral Artery territories 3. Imaging findings demonstrating signs of ischemia in the anterior circulation, consistent with the clinical diagnosis 4. Baseline NIHSS = 7 and = 18 within 2 hours prior to implantation. 5. Ability to initiate treatment within 8- 24 hours from stroke onset 6. Signed informed consent from patient him/herself or legally authorized representative if applicable Exclusion Criteria: 1. Intracranial hemorrhage or hemorrhagic transformation 2. Massive stroke 3. Acute ischemic stroke in the posterior circulation 4. Minor stroke 5. Treated with IV-tPA (intravenous tissue Plasminogen Activator) ,IA-tPA (intra-arterial tissue Plasminogen Activator) or neurothrombectomy devices for the current stroke 6. Previous stroke in the last 6 months or pre-existing disability 7. Patients with bleeding propensity or any condition in the oral cavity that prevents implantation 8. Clinical signs and symptoms or imaging evidence of bilateral stroke. 9. Treated with IV-tPA ,IA-tPA or neurothrombectomy devices for the current stroke. 10. Known cerebral arteriovenous malformation, cerebral aneurysm. 11. Clinical suspicion of septic embolus. 12. Uncontrolled hypertension (systolic >185 mmHg and/or diastolic >110 mmHg) 13. Serious systemic infection. 14. Women known to be pregnant or having a positive or indeterminate pregnancy test. 15. Patients with other implanted neural stimulator/ electronic devices (pacemakers). 16. Life expectancy < 1 year from causes other than stroke. |
Country | Name | City | State |
---|---|---|---|
Canada | Foothills Medical Centre/University of Calgary, Department of Clinical Neurosciences | Calgary | |
Canada | Department of Medicine, Stroke Program, University of Alberta Hospital | Edmonton | |
Czechia | University Hospital of Ostrava, Ostrava Poruba | Poruba | |
Czechia | General University Hospital | Prague | |
Czechia | Vitkovicka nemocnice a.s. Ostrava Vitkovice | Vítkovice | |
Denmark | Aarhus University Hospital | Aarhus | |
Finland | Helsinki University Hospital | Helsinki | |
Finland | Kuopio University Hospital | Kuopio | |
France | Hospital de la Cavale Blanche | Brest | |
France | Hospital Nord Laennec | Nantes | |
France | Hospital Saint Roch | Nice | |
France | Hopital Lariboisiere | Paris | |
France | Hospital Pontchaillou | Rennes | |
Georgia | Unimed Adjara Batumi Referral Hospital | Batumi | |
Georgia | Kutaisi Referral Hospital | Kutaisi | |
Georgia | Rustavi Central Hospital | Rustavi | |
Georgia | Emergency Neurology Clinic Neurology Ltd. | Tbilisi | |
Georgia | First University Clinic | Tbilisi | |
Georgia | High Technology Medical Center University Clinic LTD. | Tbilisi | |
Georgia | Zugdidi Referral Hospital | Zugdidi | |
Germany | Altenburg Clinic of Neurology | Altenburg | |
Germany | Bad Neustadt Neurological Clinic | Bad Neustadt An Der Saale | |
Germany | Center for Stroke Research at Charite University of Berlin | Berlin | |
Germany | Erlangen University Clinic | Erlangen | |
Germany | Essen University Clinic | Essen | |
Germany | Heidelberg University Clinic | Heidelberg | |
Germany | Leipzig University Clinic | Leipzig | |
Germany | Technical University Munich | Munich | |
Germany | Schwarzwald-Baar Clinic | Villingen-Schwenningen | |
Hong Kong | Prince of Wales Hospital | Hong Kong | |
Hong Kong | Queen Mary Hospital | Hong Kong | |
Israel | Barzilai Medical Center | Ashkelon | |
Israel | Hadassah Medical Center | Jerusalem | |
Israel | Rabin Medical Center | Petah tikva | |
Israel | Sourasky Medical Center | Tel Aviv | |
Israel | The Chaim Sheba Medical Center | Tel HaShomer | |
Italy | Hospital Sant'Andrea delle Fratte | Perugia | |
Italy | Policlinico Umberto I | Roma | |
North Macedonia | University Clinic for Neurology | Skopje | |
Poland | Bialystok University Hospital | Bialystok | |
Poland | Konske Hospital | Konskie | |
Poland | University Hospital in Krakow | Kraków | |
Poland | Sandomierz Hospital | Sandomierz | |
Poland | Torun Hospital | Torun | |
Poland | Institute of Psychiatry and Neurology | Warsaw | |
Portugal | Hospital Fernando Fonseca | Amadora | |
Portugal | Hospital de Santo Antonio | Porto | |
Portugal | Unidade de AVC Centro Hospitalar São João | Porto | |
Portugal | Centro Hospitalar de Douro e Vouga, EPE - Hospital de São Sebastião | Santa Maria | |
Serbia | Special Hospital for Cerebrovascular Disease Sveti Sava | Belgrade | |
Serbia | Clinical Centre of Vojvodina | Novi Sad | |
Serbia | Clinical Hospital Center Zemun | Zemun | |
Slovakia | Neurologické Oddelenie, Nemocnica s Poliklinikou Spišská | Nová Ves | |
Slovakia | Neurologické Oddelenie FN Trnava, Fakultná Nemocnica | Trnava | |
Spain | Hospitalario Universitario de Albacete | Albacete | |
Spain | Hospital de la Santa Creu I Sant Pau | Barcelona | |
Spain | Hospital del Mar | Barcelona | |
Spain | Hospital Universitari de Bellvitge | Barcelona | |
Spain | Hospital Vall d'Hebron | Barcelona | |
Spain | Hospital Arnau de Vilanova | Lleida | |
Spain | Hospital Gregorio Maranon | Madrid | |
Spain | Ramon Y Cajal | Madrid | |
Spain | Hospital Universitario Son Dureta | Palma De Mallorca | |
Spain | Complejo Hospitalarion Univiersitario de Santiago | Santiago De Compostela | |
Spain | Valladolid - Hospital Clinico | Valladolid | |
Ukraine | Lviv National Medical University | Lviv | |
United States | Erlanger Stroke Center | Chattanooga | Tennessee |
United States | Palmetto Health Richland | Columbia | South Carolina |
United States | Guilford Neurologic Associates | Greensboro | North Carolina |
United States | Intercoastal Medical Group | Sarasota | Florida |
United States | University of Toledo Medical Center- Campus 1 | Toledo | Ohio |
United States | University of Toledo Medical Center- Campus 2 | Toledo | Ohio |
United States | Central DuPage Hospital | Winfield | Illinois |
Lead Sponsor | Collaborator |
---|---|
BrainsGate |
United States, Canada, Czechia, Denmark, Finland, France, Georgia, Germany, Hong Kong, Israel, Italy, North Macedonia, Poland, Portugal, Serbia, Slovakia, Spain, Ukraine,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Subgroup analysis | Primary parameters subgroup analysis by: NIHSS strata, lesion size, time from stroke onset strata, gender, age strata, Diabetes (Y/N), Atrial Fibrillation AFIB (Y/N) and side | 90 days±7 days | |
Other | Additional clinical efficacy outcome: SIS-16 | Stroke-related quality of life at 3 months according to the Stroke Impact Scale-16 (SIS-16) | 90 days±7 days | |
Other | Additional clinical efficacy outcome: Dichotomy 0-2 mRS at 3 months | Functional independence at 3 months (modified Rankin Scale 0-2) | 90 days±7 days | |
Other | Additional clinical efficacy outcome: Dichotomy 0-3 mRS at 3 months | Up to moderate disability but ambulatory at 3 months (modified Rankin Scale 0-3) | 90 days±7 days | |
Other | Safety outcome: Serious Adverse Event (SAE) | All Serious Adverse Events (SAEs) | 90 days±7 days | |
Other | Safety outcome: Serious Adverse Event (SAE) - Implantation | SAEs related to implant placement or removal | 90 days±7 days | |
Other | Safety outcome: Serious Adverse Event (SAE) - Stimulation | SAEs related to stimulation | 90 days±7 days | |
Other | Safety outcome: Neurological Deterioration | An increase of 4 or more points on the NIHSS related to any neurological event within the first 10 days after stroke onset | 10 days | |
Other | Safety outcome: Mortality | Mortality | 90 days±7 days | |
Primary | Sliding Dichotomy modified Rankin Scale (mRS) at 3 months | The primary efficacy endpoint is improvement beyond expectations on the modified Rankin Scale at 3 months (sliding dichotomy), assessed in primary populations of: modified intention to treat (mITT) confirmed cortical involvement (CCI), defined as baseline NIHSS = 10 and signs of cortical involvement in baseline imaging (at least one of the following ASPECT regions: M1-M6, Insular Cortex) Type I Error is controlled at an overall level of 0.05 (two-sided) using the Hochberg method. |
90 days±7 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05196659 -
Collaborative Quality Improvement (C-QIP) Study
|
N/A | |
Recruiting |
NCT06027788 -
CTSN Embolic Protection Trial
|
N/A | |
Completed |
NCT03281590 -
Stroke and Cerebrovascular Diseases Registry
|
||
Recruiting |
NCT05518305 -
Platelet Expression of FcγRIIa and Arterial Hemodynamics to Predict Recurrent Stroke in Intracranial Atherosclerosis
|
||
Recruiting |
NCT06029959 -
Stroke and CPAP Outcome Study 3
|
N/A | |
Recruiting |
NCT03728738 -
Zero Degree Head Positioning in Hyperacute Large Artery Ischemic Stroke
|
Phase 3 | |
Terminated |
NCT03396419 -
IMPACT- 24col Collateral Blood Flow Assessment Following SPG Stimulation in Acute Ischemic Stroke (ImpACT-24B Sub-Study)
|
||
Recruiting |
NCT05065216 -
Treatment of Acute Ischemic Stroke (ReMEDy2 Trial)
|
Phase 2/Phase 3 | |
Recruiting |
NCT04897334 -
Transcranial Direct Current Stimulation and Rehabilitation to Ameliorate Impairments in Neurocognition After Stroke
|
N/A | |
Not yet recruiting |
NCT06462599 -
Osteopontin Gene Polymorphism in Stroke Patients in Egypt
|
||
Not yet recruiting |
NCT06032819 -
Differentiating Between Brain Hemorrhage and Contrast
|
||
Not yet recruiting |
NCT06026696 -
Cohort of Neurovascular Diseases Treated in the Acute Phase and Followed at Lariboisière
|
||
Recruiting |
NCT02910180 -
Genetic, Metabolic, and Growth Factor Repository for Cerebrovascular Disorders
|
||
Withdrawn |
NCT01866189 -
Identification of Hypoxic Brain Tissues by F-MISO PET in Acute Ischemic Stroke
|
N/A | |
Completed |
NCT02922452 -
A Study to Evaluate the Effect of Diltiazem on the Pharmacokinetics (PK) of BMS-986141 in Healthy Subjects
|
Phase 1 | |
Completed |
NCT03554642 -
Walkbot Robotic Training for Improvement in Gait
|
Phase 3 | |
Recruiting |
NCT03041753 -
Reperfusion Injury After Stroke Study
|
N/A | |
Completed |
NCT02549846 -
AdminiStration of Statin On Acute Ischemic stRoke patienT Trial
|
Phase 4 | |
Completed |
NCT02610803 -
Paroxysmal Atrial Fibrillation in Patients With Acute Ischemic Stroke
|
N/A | |
Completed |
NCT01678534 -
Reparative Therapy in Acute Ischemic Stroke With Allogenic Mesenchymal Stem Cells From Adipose Tissue, Safety Assessment, a Randomised, Double Blind Placebo Controlled Single Center Pilot Clinical Trial
|
Phase 2 |