Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06440707
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-23
Brief Title:
Transcranial Direct Current Stimulation for Treatment of Acute Ischemic Stroke
Sponsor:
Redacted
Organization:
Redacted
Study Overview
Official Title:
Transcranial Electrical Stimulation in Stroke EaRly After Onset Clinical Trial 2
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
True
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TESSERACT 2
Brief Summary:
Many patients with acute ischemic stroke are ineligible for currently available standard treatments clot-busting medication also known as intravenous thrombolytic or mechanical removal of a clot and many are non-responders resulting in a low rate of excellent outcomes which necessitates the development of novel therapies
In this study investigators are testing a new treatment in which a weak electrical current will be applied via scalp electrodes to increase collateral blood flow to the brain and rescue the brain tissue at risk of injury The primary aim is to find an optimal dose of this therapy that is both adequately safe and effective on imaging markers of brain tissue rescue
In this study investigators are testing a new treatment in which a weak electrical current will be applied via scalp electrodes to increase collateral blood flow to the brain and rescue the brain tissue at risk of injury The primary aim is to find an optimal dose of this therapy that is both adequately safe and effective on imaging markers of brain tissue rescue
Detailed Description:
This multi-site phase 2a randomized sham-controlled adaptive study aims to identify an optimal dose of a new treatment cathodal direct current stimulation or C-tDCS for acute ischemic stroke This new treatment involves applying a weak inhibitory electrical current to the brain via scalp electrodes in acute stroke patients The weak electrical current will electrically protect the brain cells not receiving enough oxygen and nutrients due to blood vessel blockage and increase the collateral blood flow to the brain
The study primarily aims to find an optimal dose that shows adequate safety and effectiveness on markers of brain protection and collateral blood flow enhancement using brain scan The investigators will ask acute stroke patients who arrive at the Emergency Departments of the University of California Los Angeles UCLA Duke and Johns Hopkins Medical Center and are not candidates for clot removal procedure endovascular thrombectomy to participate in the study The study enrolls patients in 2 subgroups depending on their eligibility for clot-busting medication also known as thrombolytics thrombolytic receiving and thrombolytic ineligible groups Then patients will be randomized in a 5 to 1 ratio to receive active stimulation versus sham control with no stimulation
Amongst patients randomized to the active arm different doses of electrical current will be tested in various ranks increasing the strength and the total duration of the electrical current at higher ranks Computer simulation techniques Bayesian method will decide which dose patients should be assigned The deciding rules of whether to escalate versus de-escalate versus stay on the same dose rank will be the probabilities of brain bleeding of 40 and substantial rescue of brain tissue at risk of permanent injury of 70 The functional features and rules of the mathematical technique Bayesian will justify enrolling up to 50 patients in each subgroup of lytic-receiving and non-lytic-receiving patients a total of up to 100 patients in active groups Additionally 10 sham control patients will be enrolled in each subgroup a total of up to 20 patients in sham groups
At 24-30 hours after the study stimulation patients will receive a brain MRI to assess the presence of any brain bleed and how much brain tissue is rescued primary aims as well as to examine the additional effects of the study stimulation on brain collateral blood flow and the growth of the permanently damaged brain tissue
As part of the studys additional goals the treatments tolerability will be studied by asking patients about how they feel during and after each session Patients will also be neurologically examined after each session Four days after enrollment a brief neurological assessment will be performed if the patient is still in the hospital On day 30 patients will receive a call from research personnel to see how they are doing On day 90 they will be asked to come to neurology clinic to be neurologically assessed The information gathered from this study will be used to advance this new treatment to future larger studies
The study primarily aims to find an optimal dose that shows adequate safety and effectiveness on markers of brain protection and collateral blood flow enhancement using brain scan The investigators will ask acute stroke patients who arrive at the Emergency Departments of the University of California Los Angeles UCLA Duke and Johns Hopkins Medical Center and are not candidates for clot removal procedure endovascular thrombectomy to participate in the study The study enrolls patients in 2 subgroups depending on their eligibility for clot-busting medication also known as thrombolytics thrombolytic receiving and thrombolytic ineligible groups Then patients will be randomized in a 5 to 1 ratio to receive active stimulation versus sham control with no stimulation
Amongst patients randomized to the active arm different doses of electrical current will be tested in various ranks increasing the strength and the total duration of the electrical current at higher ranks Computer simulation techniques Bayesian method will decide which dose patients should be assigned The deciding rules of whether to escalate versus de-escalate versus stay on the same dose rank will be the probabilities of brain bleeding of 40 and substantial rescue of brain tissue at risk of permanent injury of 70 The functional features and rules of the mathematical technique Bayesian will justify enrolling up to 50 patients in each subgroup of lytic-receiving and non-lytic-receiving patients a total of up to 100 patients in active groups Additionally 10 sham control patients will be enrolled in each subgroup a total of up to 20 patients in sham groups
At 24-30 hours after the study stimulation patients will receive a brain MRI to assess the presence of any brain bleed and how much brain tissue is rescued primary aims as well as to examine the additional effects of the study stimulation on brain collateral blood flow and the growth of the permanently damaged brain tissue
As part of the studys additional goals the treatments tolerability will be studied by asking patients about how they feel during and after each session Patients will also be neurologically examined after each session Four days after enrollment a brief neurological assessment will be performed if the patient is still in the hospital On day 30 patients will receive a call from research personnel to see how they are doing On day 90 they will be asked to come to neurology clinic to be neurologically assessed The information gathered from this study will be used to advance this new treatment to future larger studies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None