Ischemic StrokeTTM-STROKENCT07096687
Targeted Temperature Management in Acute Ischemic Stroke
A study testing Targeted Temperature Management with CB240_Aurora in people with Ischemic Stroke, run by Azienda Usl di Bologna at 1 site in Italy.
Trial summary
The goal of this interventional trial is to evaluate whether the CB240_Aurora medical device is effective for targeted temperature management in adult patients with acute ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Targeted Temperature Management with CB240_Aurora
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteItaly
- Study dates
- 11 Sep 2025to 31 Mar 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years;
- Both sexes;
- Diagnosis of acute ischemic stroke confirmed by clinical evaluation by a neurologist and neuroimaging (CT or brain MRI);
- Acute ischemic stroke with symptom onset within 48 hours;
- Anterior circulation stroke with evidence on neuroimaging (CT angiography) of occlusion of the middle cerebral artery in segments M1, M2, or M3;
- NIHSS score between 6 and 25;
Show all 9Show fewer
- First clinical stroke;
- Axillary temperature ≥36°C and <37°C;
- Informed consent obtained for study participation.
Who cannot join
- Stroke involving multiple vascular territories;
- Presence of intracerebral hemorrhage;
- Pregnancy;
- Moderate-to-severe or severe pre-stroke disability defined as mRS >3;
- Presence of a cardiac pacemaker or any other conditions contraindicating brain MRI.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Istituto delle Scienze Neurologiche di Bologna - AUSL of Bologna
Bologna, Bologna, 40139
Andrea Zini, +390516478810, a.zini@ausl.bologna.it
About this study
Official title: Targeted Temperature Management for Neuroprotection in Acute Ischemic Stroke: A Randomized Controlled Pilot Trial
The goal of this interventional trial is to evaluate whether the CB240_Aurora medical device is effective for targeted temperature management in adult patients with acute ischemic stroke. The main questions it aims to answer are: Is the CB240_Aurora effective in maintaining normothermia in patients with acute ischemic stroke? Does the medical device improve clinical and radiological outcomes? Is the medical device well tolerated by patients? Researchers will compare an interventional arm, in which the CB240_Aurora measures and treats body temperature to maintain normothermia, with a control arm, in which the CB240_Aurora only measures but does not treat body temperature. Participants will wear the medical device for 72 consecutive hours in the Stroke Unit. Outcome assessments will be performed at 72 hours, 7 days, and 3 months.
Read the detailed description
Neuroprotection is a potential therapeutic strategy to complement reperfusion and prevent the progression of cerebral ischemia in patients with acute ischemic stroke. One of the most promising approaches is Targeted Temperature Management (TTM), which involves controlling body temperature to prevent fever, maintain normothermia, or induce hypothermia in order to reduce brain injury and improve clinical outcomes. While hypothermia has demonstrated clinical benefits in patients with cardiac arrest and hypoxic- schemic encephalopathy, no significant evidence currently supports its efficacy in acute stroke. Maintaining normothermia through TTM may offer similar neuroprotective benefits with fewer complications. Current guidelines for patients with intracerebral hemorrhage, subarachnoid hemorrhage, and ischemic stroke recommend maintaining body temperature between 36°C and 37.5°C, ideally using automated control systems.
In this context, Neuron Guard has developed the CB240_Aurora device, which targets cerebral temperature through the vascular anatomy of the neck to enhance heat exchange. This system has shown potential in stabilizing brain temperature while maintaining systemic normothermia and reducing systemic side effects. Its use could be extended beyond intensive care settings to broader patient populations, both for managing fever episodes and for enhancing neuroprotection.
The experimental treatment with the CB240_Aurora device is designed as a complementary approach to standard therapies, aiming to improve their effectiveness. The device will continuously monitor body temperature and deliver treatment to maintain normothermia, defined as a temperature ≥36°C and <37°C at the time of study inclusion.
In the control group, patients will receive care according to the latest ischemic stroke treatment guidelines, including standard temperature management. In this group, the CB240_Aurora device will be used exclusively for temperature monitoring without providing active treatment.
- Conditions
- Ischemic Stroke
- Being tested
- Targeted Temperature Management with CB240_Aurora, Standard of care Temperature treatment
- Keywords
- ischemic stroke, neuroprotection, targeted temperature management
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted Temperature Management with CB240_AuroraDevice
The proposed experimental treatment with the CB240_Aurora device will serve as a complementary approach to standard therapies, aiming to enhance their effectiveness. The device will continuously monitor body temperature and deliver treatment to maintain normothermia, defined as a temperature ≥36°C and <37°C at the time of study inclusion.
Standard of care Temperature treatmentDevice
In the control group, patients will receive treatment according to the latest guidelines for the management of ischemic stroke, including standard body temperature management. The CB240_Aurora device will be used exclusively in monitoring mode, without delivering any active treatment, and will be maintained for 72 consecutive hours from the time of enrollment
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Patients will receive targeted temperature management to maintain normothermia using the CB240_Aurora device. Receives: Device: Targeted Temperature Management with CB240_Aurora; Device: Standard of care Temperature treatment |
| Control Arm | Sham comparator | CB240_Aurora device used exclusively in temperature monitoring and control mode according to clinical standards Receives: Device: Standard of care Temperature treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of normothermia maintenance during the first 72 hours
Measure the duration (in hours) of maintained normothermia (between >36°C and <37°C) through axillary temperature monitoring during the first 72 hours.
Measured: T0 (0 hour)T1; ( 72 hours)
Secondary outcomes (7)
Modified Rankin Scale (mRS)
Functional outcome at 3 months, defined as the Modified Rankin Scale (mRS) score ranging from 0 to 6, with higher scores indicating worse outcomes
Measured: T2 (day 7); T3 (day 90)
National Institutes of Health Stroke Scale (NIHSS)
Clinical outcome at 7 days, defined as the National Institutes of Health Stroke Scale (NIHSS) score ranging from 0 to 42, with higher scores indicating worse outcomes
Measured: T2 (day 7); T3 (day 90)
Change in the volume of the ischemic lesion measured by MRI
Ischemic lesion volume will be evaluated by MRI at day 7 from randomization (T0)
Measured: T2 (day 7)
hemorrhagic transformation of the ischemic lesion at MRI
hemorrhagic transformation of the ischemic lesion at MRI
Measured: T2 (day 7)
Incidence of adverse events (AEs) and severe AEs (SAEs) that are related to treatment.
Safety will be assessed by measuring the incidence of AEs and SAEs throughout the stimulation period and during the 3-month follow-up
Measured: T0 (day 0); T1 (day 3); T2 (day 7); T3( day 90)
Number of patients requiring to stop treatment sessions
Measured: from T0 (day 0); T3 (day 90)
Qualitative assessment of device tollerability (QADT)
An ad hoc questionnaire to assess the tolerability of the device (e.g., nausea, headache, palpitations, anxiety, sweating) will be administered daily during the entire hospital stay and, after discharge, at each outpatient follow-up visit. Responses will be categorized as: Response No (Better Outcome) and Response Yes (Worse Outcome).
Measured: T2 (day 7); T3 (day 90)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start11 Sep 2025
- Primary completionSep 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Ischemic 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Usl di Bologna
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Andrea Zini, Principal investigator, IRCCS Istituto delle Scienze Neurologiche di Bologna - AUSL of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07096687
- Sponsor's protocol ID
- TTM-STROKE
- Acronym
- TTM-STROKE
- Status last verified
- Sep 2025
- First submitted
- 24 Jul 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lavinio A, Beqiri E, Kataria K. A Novel Technology for Targeted Brain Temperature Management. Neurocrit Care. 2024 Apr;40(2):785-790. doi: 10.1007/s12028-023-01800-7. Epub 2023 Jul 27. No abstract available.
PubMed 37498461Lavinio A, Andrzejowski J, Antonopoulou I, Coles J, Geoghegan P, Gibson K, Gudibande S, Lopez-Soto C, Mullhi R, Nair P, Pauliah VP, Quinn A, Rasulo F, Ratcliffe A, Reddy U, Rhodes J, Robba C, Wiles M, Williams A. Targeted temperature management in patients with intracerebral haemorrhage, subarachnoid haemorrhage, or acute ischaemic stroke: updated consensus guideline recommendations by the Neuroprotective Therapy Consensus Review (NTCR) group. Br J Anaesth. 2023 Aug;131(2):294-301. doi: 10.1016/j.bja.2023.04.030. Epub 2023 May 22.
PubMed 37225535Dankiewicz J, Cronberg T, Lilja G, Jakobsen JC, Levin H, Ullen S, Rylander C, Wise MP, Oddo M, Cariou A, Belohlavek J, Hovdenes J, Saxena M, Kirkegaard H, Young PJ, Pelosi P, Storm C, Taccone FS, Joannidis M, Callaway C, Eastwood GM, Morgan MPG, Nordberg P, Erlinge D, Nichol AD, Chew MS, Hollenberg J, Thomas M, Bewley J, Sweet K, Grejs AM, Christensen S, Haenggi M, Levis A, Lundin A, During J, Schmidbauer S, Keeble TR, Karamasis GV, Schrag C, Faessler E, Smid O, Otahal M, Maggiorini M, Wendel Garcia PD, Jaubert P, Cole JM, Solar M, Borgquist O, Leithner C, Abed-Maillard S, Navarra L, Annborn M, Unden J, Brunetti I, Awad A, McGuigan P, Bjorkholt Olsen R, Cassina T, Vignon P, Langeland H, Lange T, Friberg H, Nielsen N; TTM2 Trial Investigators. Hypothermia versus Normothermia after Out-of-Hospital Cardiac Arrest. N Engl J Med. 2021 Jun 17;384(24):2283-2294. doi: 10.1056/NEJMoa2100591.
PubMed 34133859Wang H, Olivero W, Lanzino G, Elkins W, Rose J, Honings D, Rodde M, Burnham J, Wang D. Rapid and selective cerebral hypothermia achieved using a cooling helmet. J Neurosurg. 2004 Feb;100(2):272-7. doi: 10.3171/jns.2004.100.2.0272.
PubMed 15086235Lyden P, Hemmen T, Grotta J, Rapp K, Ernstrom K, Rzesiewicz T, Parker S, Concha M, Hussain S, Agarwal S, Meyer B, Jurf J, Altafullah I, Raman R; Collaborators. Results of the ICTuS 2 Trial (Intravascular Cooling in the Treatment of Stroke 2). Stroke. 2016 Dec;47(12):2888-2895. doi: 10.1161/STROKEAHA.116.014200. Epub 2016 Nov 10.
PubMed 27834742Lyden PD, Allgren RL, Ng K, Akins P, Meyer B, Al-Sanani F, Lutsep H, Dobak J, Matsubara BS, Zivin J. Intravascular Cooling in the Treatment of Stroke (ICTuS): early clinical experience. J Stroke Cerebrovasc Dis. 2005 May-Jun;14(3):107-14. doi: 10.1016/j.jstrokecerebrovasdis.2005.01.001.
PubMed 17904009You JS, Kim JY, Yenari MA. Therapeutic hypothermia for stroke: Unique challenges at the bedside. Front Neurol. 2022 Oct 3;13:951586. doi: 10.3389/fneur.2022.951586. eCollection 2022.
PubMed 36262833Yenari MA, Han HS. Neuroprotective mechanisms of hypothermia in brain ischaemia. Nat Rev Neurosci. 2012 Feb 22;13(4):267-78. doi: 10.1038/nrn3174.
PubMed 22353781Edwards AD, Brocklehurst P, Gunn AJ, Halliday H, Juszczak E, Levene M, Strohm B, Thoresen M, Whitelaw A, Azzopardi D. Neurological outcomes at 18 months of age after moderate hypothermia for perinatal hypoxic ischaemic encephalopathy: synthesis and meta-analysis of trial data. BMJ. 2010 Feb 9;340:c363. doi: 10.1136/bmj.c363.
PubMed 20144981Hypothermia after Cardiac Arrest Study Group. Mild therapeutic hypothermia to improve the neurologic outcome after cardiac arrest. N Engl J Med. 2002 Feb 21;346(8):549-56. doi: 10.1056/NEJMoa012689.
PubMed 11856793Bernard SA, Gray TW, Buist MD, Jones BM, Silvester W, Gutteridge G, Smith K. Treatment of comatose survivors of out-of-hospital cardiac arrest with induced hypothermia. N Engl J Med. 2002 Feb 21;346(8):557-63. doi: 10.1056/NEJMoa003289.
PubMed 11856794Reith J, Jorgensen HS, Pedersen PM, Nakayama H, Raaschou HO, Jeppesen LL, Olsen TS. Body temperature in acute stroke: relation to stroke severity, infarct size, mortality, and outcome. Lancet. 1996 Feb 17;347(8999):422-5. doi: 10.1016/s0140-6736(96)90008-2.
PubMed 8618482Madden LK, Hill M, May TL, Human T, Guanci MM, Jacobi J, Moreda MV, Badjatia N. The Implementation of Targeted Temperature Management: An Evidence-Based Guideline from the Neurocritical Care Society. Neurocrit Care. 2017 Dec;27(3):468-487. doi: 10.1007/s12028-017-0469-5.
PubMed 29038971Donnan GA, Davis SM, Parsons MW, Ma H, Dewey HM, Howells DW. How to make better use of thrombolytic therapy in acute ischemic stroke. Nat Rev Neurol. 2011 Jun 14;7(7):400-9. doi: 10.1038/nrneurol.2011.89.
PubMed 21670766Savitz SI, Baron JC, Yenari MA, Sanossian N, Fisher M. Reconsidering Neuroprotection in the Reperfusion Era. Stroke. 2017 Dec;48(12):3413-3419. doi: 10.1161/STROKEAHA.117.017283. Epub 2017 Nov 16. No abstract available.
PubMed 29146878
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Temperature Management for Neuroprotection in Acute Ischemic Stroke: A Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT07096687
- Acronym / sponsor ID
- TTM-STROKE / TTM-STROKE
- Conditions
- Ischemic Stroke
- Keywords
- ischemic stroke, neuroprotection, targeted temperature management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Azienda Usl di BolognaOther government
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 31 Jul 2025 (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 goal of this interventional trial is to evaluate whether the CB240_Aurora medical device is effective for targeted temperature management in adult patients with acute ischemic stroke. The main questions it aims to answer are: Is the CB240_Aurora effective in maintaining normothermia in patients with acute ischemic stroke? Does the medical device improve clinical and radiological outcomes? Is the medical device well tolerated by patients? Researchers will compare an interventional arm, in which the CB240_Aurora measures and treats body temperature to maintain normothermia, with a control arm, in which the CB240_Aurora only measures but does not treat body temperature. Participants will wear the medical device for 72 consecutive hours in the Stroke Unit. Outcome assessments will be performed at 72 hours, 7 days, and 3 months.
Detailed description
Neuroprotection is a potential therapeutic strategy to complement reperfusion and prevent the progression of cerebral ischemia in patients with acute ischemic stroke. One of the most promising approaches is Targeted Temperature Management (TTM), which involves controlling body temperature to prevent fever, maintain normothermia, or induce hypothermia in order to reduce brain injury and improve clinical outcomes. While hypothermia has demonstrated clinical benefits in patients with cardiac arrest and hypoxic- schemic encephalopathy, no significant evidence currently supports its efficacy in acute stroke. Maintaining normothermia through TTM may offer similar neuroprotective benefits with fewer complications. Current guidelines for patients with intracerebral hemorrhage, subarachnoid hemorrhage, and ischemic stroke recommend maintaining body temperature between 36°C and 37.5°C, ideally using automated control systems.
In this context, Neuron Guard has developed the CB240_Aurora device, which targets cerebral temperature through the vascular anatomy of the neck to enhance heat exchange. This system has shown potential in stabilizing brain temperature while maintaining systemic normothermia and reducing systemic side effects. Its use could be extended beyond intensive care settings to broader patient populations, both for managing fever episodes and for enhancing neuroprotection.
The experimental treatment with the CB240_Aurora device is designed as a complementary approach to standard therapies, aiming to improve their effectiveness. The device will continuously monitor body temperature and deliver treatment to maintain normothermia, defined as a temperature ≥36°C and <37°C at the time of study inclusion.
In the control group, patients will receive care according to the latest ischemic stroke treatment guidelines, including standard temperature management. In this group, the CB240_Aurora device will be used exclusively for temperature monitoring without providing active treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Device: Targeted Temperature Management with CB240_Aurora, Device: Standard of care Temperature treatmentPatients will receive targeted temperature management to maintain normothermia using the CB240_Aurora device. |
| Control Arm | Sham comparator | Device: Standard of care Temperature treatmentCB240_Aurora device used exclusively in temperature monitoring and control mode according to clinical standards |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age >18 years;
- Both sexes;
- Diagnosis of acute ischemic stroke confirmed by clinical evaluation by a neurologist and neuroimaging (CT or brain MRI);
- Acute ischemic stroke with symptom onset within 48 hours;
- Anterior circulation stroke with evidence on neuroimaging (CT angiography) of occlusion of the middle cerebral artery in segments M1, M2, or M3;
Key exclusion criteria (5 listed)
- Stroke involving multiple vascular territories;
- Presence of intracerebral hemorrhage;
- Pregnancy;
- Moderate-to-severe or severe pre-stroke disability defined as mRS >3;
- Presence of a cardiac pacemaker or any other conditions contraindicating brain MRI.
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 |
|---|---|---|
| Targeted Temperature Management with CB240_AuroraThe proposed experimental treatment with the CB240_Aurora device will serve as a complementary approach to standard therapies, aiming to enhance their effectiveness. The device will continuously monitor body temperature and deliver treatment to maintain normothermia, defined as a temperature ≥36°C and <37°C at the time of study inclusion. | Device | Intervention Arm |
| Standard of care Temperature treatmentIn the control group, patients will receive treatment according to the latest guidelines for the management of ischemic stroke, including standard body temperature management. The CB240_Aurora device will be used exclusively in monitoring mode, without delivering any active treatment, and will be maintained for 72 consecutive hours from the time of enrollment | Device | Control Arm, Intervention Arm |
Primary outcome
Duration of normothermia maintenance during the first 72 hours
Time frame: T0 (0 hour)T1; ( 72 hours)
Measure the duration (in hours) of maintained normothermia (between >36°C and <37°C) through axillary temperature monitoring during the first 72 hours.
7 secondary outcomes
Modified Rankin Scale (mRS)
Time frame: T2 (day 7); T3 (day 90)
National Institutes of Health Stroke Scale (NIHSS)
Time frame: T2 (day 7); T3 (day 90)
Change in the volume of the ischemic lesion measured by MRI
Time frame: T2 (day 7)
hemorrhagic transformation of the ischemic lesion at MRI
Time frame: T2 (day 7)
Incidence of adverse events (AEs) and severe AEs (SAEs) that are related to treatment.
Time frame: T0 (day 0); T1 (day 3); T2 (day 7); T3( day 90)
Number of patients requiring to stop treatment sessions
Time frame: from T0 (day 0); T3 (day 90)
Qualitative assessment of device tollerability (QADT)
Time frame: T2 (day 7); T3 (day 90)
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 17 Sep 2025.
- Background: PubMed 37498461Lavinio A, Beqiri E, Kataria K. A Novel Technology for Targeted Brain Temperature Management. Neurocrit Care. 2024 Apr;40(2):785-790. doi: 10.1007/s12028-023-01800-7. Epub 2023 Jul 27. No abstract available.
- Background: PubMed 37225535Lavinio A, Andrzejowski J, Antonopoulou I, Coles J, Geoghegan P, Gibson K, Gudibande S, Lopez-Soto C, Mullhi R, Nair P, Pauliah VP, Quinn A, Rasulo F, Ratcliffe A, Reddy U, Rhodes J, Robba C, Wiles M, Williams A. Targeted temperature management in patients with intracerebral haemorrhage, subarachnoid haemorrhage, or acute ischaemic stroke: updated consensus guideline recommendations by the Neuroprotective Therapy Consensus Review (NTCR) group. Br J Anaesth. 2023 Aug;131(2):294-301. doi: 10.1016/j.bja.2023.04.030. Epub 2023 May 22.
- Background: PubMed 34133859Dankiewicz J, Cronberg T, Lilja G, Jakobsen JC, Levin H, Ullen S, Rylander C, Wise MP, Oddo M, Cariou A, Belohlavek J, Hovdenes J, Saxena M, Kirkegaard H, Young PJ, Pelosi P, Storm C, Taccone FS, Joannidis M, Callaway C, Eastwood GM, Morgan MPG, Nordberg P, Erlinge D, Nichol AD, Chew MS, Hollenberg J, Thomas M, Bewley J, Sweet K, Grejs AM, Christensen S, Haenggi M, Levis A, Lundin A, During J, Schmidbauer S, Keeble TR, Karamasis GV, Schrag C, Faessler E, Smid O, Otahal M, Maggiorini M, Wendel Garcia PD, Jaubert P, Cole JM, Solar M, Borgquist O, Leithner C, Abed-Maillard S, Navarra L, Annborn M, Unden J, Brunetti I, Awad A, McGuigan P, Bjorkholt Olsen R, Cassina T, Vignon P, Langeland H, Lange T, Friberg H, Nielsen N; TTM2 Trial Investigators. Hypothermia versus Normothermia after Out-of-Hospital Cardiac Arrest. N Engl J Med. 2021 Jun 17;384(24):2283-2294. doi: 10.1056/NEJMoa2100591.
- Background: PubMed 15086235Wang H, Olivero W, Lanzino G, Elkins W, Rose J, Honings D, Rodde M, Burnham J, Wang D. Rapid and selective cerebral hypothermia achieved using a cooling helmet. J Neurosurg. 2004 Feb;100(2):272-7. doi: 10.3171/jns.2004.100.2.0272.
- Background: PubMed 27834742Lyden P, Hemmen T, Grotta J, Rapp K, Ernstrom K, Rzesiewicz T, Parker S, Concha M, Hussain S, Agarwal S, Meyer B, Jurf J, Altafullah I, Raman R; Collaborators. Results of the ICTuS 2 Trial (Intravascular Cooling in the Treatment of Stroke 2). Stroke. 2016 Dec;47(12):2888-2895. doi: 10.1161/STROKEAHA.116.014200. Epub 2016 Nov 10.
- Background: PubMed 17904009Lyden PD, Allgren RL, Ng K, Akins P, Meyer B, Al-Sanani F, Lutsep H, Dobak J, Matsubara BS, Zivin J. Intravascular Cooling in the Treatment of Stroke (ICTuS): early clinical experience. J Stroke Cerebrovasc Dis. 2005 May-Jun;14(3):107-14. doi: 10.1016/j.jstrokecerebrovasdis.2005.01.001.
- Background: PubMed 36262833You JS, Kim JY, Yenari MA. Therapeutic hypothermia for stroke: Unique challenges at the bedside. Front Neurol. 2022 Oct 3;13:951586. doi: 10.3389/fneur.2022.951586. eCollection 2022.
- Background: PubMed 22353781Yenari MA, Han HS. Neuroprotective mechanisms of hypothermia in brain ischaemia. Nat Rev Neurosci. 2012 Feb 22;13(4):267-78. doi: 10.1038/nrn3174.
- Background: PubMed 20144981Edwards AD, Brocklehurst P, Gunn AJ, Halliday H, Juszczak E, Levene M, Strohm B, Thoresen M, Whitelaw A, Azzopardi D. Neurological outcomes at 18 months of age after moderate hypothermia for perinatal hypoxic ischaemic encephalopathy: synthesis and meta-analysis of trial data. BMJ. 2010 Feb 9;340:c363. doi: 10.1136/bmj.c363.
- Background: PubMed 11856793Hypothermia after Cardiac Arrest Study Group. Mild therapeutic hypothermia to improve the neurologic outcome after cardiac arrest. N Engl J Med. 2002 Feb 21;346(8):549-56. doi: 10.1056/NEJMoa012689.
- Background: PubMed 11856794Bernard SA, Gray TW, Buist MD, Jones BM, Silvester W, Gutteridge G, Smith K. Treatment of comatose survivors of out-of-hospital cardiac arrest with induced hypothermia. N Engl J Med. 2002 Feb 21;346(8):557-63. doi: 10.1056/NEJMoa003289.
- Background: PubMed 8618482Reith J, Jorgensen HS, Pedersen PM, Nakayama H, Raaschou HO, Jeppesen LL, Olsen TS. Body temperature in acute stroke: relation to stroke severity, infarct size, mortality, and outcome. Lancet. 1996 Feb 17;347(8999):422-5. doi: 10.1016/s0140-6736(96)90008-2.
- Individual participant dataSharing planned: No
Related trials for Ischemic Stroke
Recruiting
Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiography SuiTe
Stroke, Acute
Not yet recruiting
EEG Feedback-Based Vagus Nerve Stimulation for Post-Stroke Dysphagia
Ischemic Stroke, Post-stroke Dysphagia
RecruitingObservational study
Development and Validation of Risk Prediction Models for Stroke and Cognitive Impairment in Moyamoya Disease and Moyamoya Syndrome
Moyamoya Disease, Moyamoya Syndrome
Recruiting
Impact of Atrial Fibrosis Surface Area on the Occurrence of Atrial Fibrillation in Patients With Ischemic Stroke of Undetermined Origin: a Prospective Cardiac MRI Pilot Study.
Stroke, Implantation of an Implantable Cardiac Monitor
Recruiting
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)
Brainstem Stroke, ALS
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.
Andrea Zini principal investigator
IRCCS Istituto delle Scienze Neurologiche di Bologna - AUSL of Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted Temperature Management with CB240_Aurora in people with Ischemic Stroke, run by Azienda Usl di Bologna at 1 site in Italy.
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 9 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: looking for participants now, as of the sponsor's last update on 17 Sep 2025. 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 Italy. 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. Some participants in this study may receive a placebo. 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 Andrea Zini (+390516478810, a.zini@ausl.bologna.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of normothermia maintenance during the first 72 hours (time frame: T0 (0 hour)T1; ( 72 hours)). 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 NCT07096687, which also lists 19 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 17 Sep 2025.