Acute Ischemic StrokeTESSERACT-BANCT04061577
Transcranial Direct Current Stimulation as a Neuroprotection in Acute Stroke Before and After Thrombectomy
A study testing Transcranial Direct Current Stimulation (tDCS) in people with Acute Ischemic Stroke, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This proposal is a prospective, single-center, dose-escalation safety, tolerability, feasibility and potential efficacy study of transcranial direct current stimulation (tDCS) in acute stroke patients with substantial salvageable penumbra due to a large vessel occlusion before and after endovascular therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Transcranial Direct Current Stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2019to 1 Apr 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- New focal neurologic deficit consistent with AIS
- Age≥18
- NIHSS ≥ 4
- ICA or M1 or M2 MCA occlusion on pre-thrombectomy MRA or CTA
- Onset (last-seen-well) time to randomization time within 24 hours
- Pre-stroke modified Rankin Scale≤ 3.
Show all 10Show fewer
- Patient ineligible for IV tPA, per national AHA/ASA Guidelines.
- Having undergone endovascular thrombectomy with less than a complete reperfusion (<TICI 2c, 3) for receiving post-thrombectomy adjunct C-tDCS.
- Undergoing endovascular thrombectomy, per national AHA/ASA Guidelines for patients who are assigned to pre-thrombectomy bridging session at Tiers 5, 6.
- A signed informed consent is obtained from the patient or patient's legally authorized representative
Who cannot join
- Acute intracranial hemorrhage
- Evidence of a large Ischemic core volume (ADC < 620 µm2/s or rCBF< 30%) ≥ 100 ml
- Presence of tDCS contraindications - electrically or magnetically activated intracranial metal and non-metal implants.
- Pregnancy
- Severe contrast allergy or absolute contraindication to iodinated contrast preventing endovascular intervention.
- History of seizure disorder or new seizures with presentation of current stroke
Show all 10Show fewer
- Evidence of any other major life-threatening or serious medical condition that would prevent completion of the study protocol including attendance at the 3-month follow-up visit
- Concomitant experimental therapy
- Preexisting scalp lesion at the site of the stimulation or presence of skull defects (may alter current flow pattern)
- Preexisting coagulopathy, consist of a platelet count of ≤ 100, INR ≥ 3, PTT ≥ 90.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California- Los Angeles (UCLA)
Los Angeles, California, 90095
About this study
Official title: Transcranial Electrical Stimulation in Stroke EaRly After Onset Clinical Trial_ Bridging and Adjunctive Neuroprotection
This proposal is a prospective, single-center, dose-escalation safety, tolerability, feasibility and potential efficacy study of transcranial direct current stimulation (tDCS) in acute stroke patients with substantial salvageable penumbra due to a large vessel occlusion before and after endovascular therapy.
Read the detailed description
This is a single-center, sham-controlled, dose-escalation study where cathodal tDCS is delivered to threatened but not yet irreversibly damaged (penumbral) tissue in patients with large vessel occlusion who are undergoing recanalization procedure. Patients will be randomized in a 3:1 design, to cathodal versus sham (control) stimulation, at each six designed dose tiers. The dose tiers will be increasing in both intensity and duration of the stimulation. All patients will be receiving the first dose (stimulation cycle) after the recanalization procedure and patients at dose tiers 5-6 will also be receiving stimulation cycles before the recanalization procedure begins.
The occurrence of symptomatic intracranial hemorrhage will determine the pace of the escalation through the dose tiers.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Transcranial Direct Current Stimulation (tDCS)
- Keywords
- Transcranial direct current stimulation, Bridging neuroprotection, Adjunctive neuroprotection
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current Stimulation (tDCS)Device
20 minutes of Cathodal tDCS after +/- before endovascular thrombectomy (EVT)
| Study group | Role | What they receive |
|---|---|---|
| Stimulation arm | Experimental | Patients will be randomized to active treatment (C-tDCS) vs sham stimulation in a 3:1 ratio. There will be 6 dose tiers:
Tier 1 - 1 mA, and Tier 2- 2 mA: Consist of a single stimulation cycle (20min) after the endovascular procedure (EVT) in patients with TICI<2c,3 and negative immediate post-EVT CT scan for definitive evidence of ICH.
Tier 3 - 1 mA and Tier 4- 2mA consist of 2 treatment cycles after the EVT in patients with TICI<2c and 3, and negative immediate post-EVT CT scan for definitive evidence of ICH.
Tier 5 - 1 mA and tier 6- 2 mA consist of 3 treatment cycles. The first cycle will be up to 20 min cycle, after initial imaging and prior to arterial puncture, the second and third cycles after EVT in patients with TICI<2c and 3 and negative immediate post-EVT CT scan for definitive evidence of ICH. Receives: Device: Transcranial Direct Current Stimulation (tDCS) |
| Sham arm | Sham comparator | Patients in the sham stimulation arm at all the tiers will have the cap and electrodes in place, and sham switch moved but without delivery of electrical stimulation. Receives: Device: Transcranial Direct Current Stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Outcome- Number of Participants With Symptomatic Intracranial Hemorrhage (SICH)
Symptomatic intracranial hemorrhage (SICH) is defined as an increase of 4 or more points on the National Institute of Health Stroke Scale (NIHSS) total score within 24 hours of stimulation associated with parenchymal hematoma type 1 (PH1), parenchymal hematoma type 2 (PH2), remote intraparenchymal hemorrhage (RIH), subarachnoid hemorrhage (SAH), or intraventricular hemorrhage (IVH).
The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute stroke on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. Accordingly, 0 is the lowest and 42 is the highest total score possible. In the NIHSS, the higher the score, the more impaired a stroke patient is.
Measured: At 24-hour post-stimulation
Primary Tolerability Outcome-Number of Participants Completing the Protocol-assigned Stimulation
The percentage of the patients completing the protocol-assigned stimulation treatment with no intolerability.
Measured: After 5 minutes of stimulation period
Primary Feasibility Outcome- Assessing the Speed of Stimulation Implementation From Randomization.
The median times from randomization to bridging C-tDCS initiation and the time form end of endovascular thrombectomy procedure to adjunctive C-tDCS initiation in the last 10 enrolled patients.
Measured: Median time from randomization to tDCS initiation
Secondary outcomes (4)
Secondary Safety Outcome-Number of Participants With Asymptomatic Intracranial Hemorrhage (AICH)
AICH is defined as intracranial hemorrhage not associated with National Institute of Health Stroke Scale (NIHSS) total score worsening of ≥ 4.
The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute stroke on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. Accordingly, 0 is the lowest and 42 is the highest total score possible. In the NIHSS, the higher the score, the more impaired a stroke patient is.
Measured: At 24-hour post-stimulation
Secondary Safety Outcome-Number of Participants With Early Neurologic Deterioration
Worsening of total score ≥ 4 on NIHSS during the 24-hour period after stimulation, with or without intracranial hemorrhage.
The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute stroke on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. Accordingly, 0 is the lowest and 42 is the highest total score possible. In the NIHSS, the higher the score, the more impaired a stroke patient is.
Measured: At 24-hour post-stimulation
Secondary Safety Outcome-Number of Participants With Mortality
Rate of mortality
Measured: At 90 days post-stimulation
Secondary Safety Outcome-Number of Participants With All Serious Adverse Events (Anticipated and Unanticipated)
A serious adverse event (SAE) is any adverse event that is fatal, is life-threatening, is permanently or substantially disabling, requires or prolongs hospitalization, or requires medical or surgical intervention to prevent one of the above outcomes. Anticipated serious adverse events were defined as SAEs that are expected and related to acute ischemic stroke complications such as headache, stroke recurrence, pneumonia, systemic blood clots, Family withdrawal of care, etc. An unanticipated serious adverse event is an SAE that is not deemed an ischemic stroke complication and adjudicated as possibly related to study treatment.
Measured: At 90 days post-stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start28 Jul 2019
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
Why it stopped: Interim Analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Sequential
- Model description
- Traditional 3+3 (rule-based, modified Fibonacci) dose-escalation design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- The City College of New York
- Responsible party
- Principal investigator, Mersedeh Bahr Hosseini, MD, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04061577
- Sponsor's protocol ID
- 19-000529
- Acronym
- TESSERACT-BA
- Status last verified
- Jun 2023
- First submitted
- 30 Jul 2019
- Last updated
- 20 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Electrical Stimulation in Stroke EaRly After Onset Clinical Trial_ Bridging and Adjunctive Neuroprotection
- ClinicalTrials.gov ID
- NCT04061577
- Acronym / sponsor ID
- TESSERACT-BA / 19-000529
- Conditions
- Acute Ischemic Stroke
- Keywords
- Transcranial direct current stimulation, Bridging neuroprotection, Adjunctive neuroprotection
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim Analysis
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- The City College of New York
- Study start
- 28 Jul 2019 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 20 Aug 2019 (actual)
- Results
- Posted 20 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This proposal is a prospective, single-center, dose-escalation safety, tolerability, feasibility and potential efficacy study of transcranial direct current stimulation (tDCS) in acute stroke patients with substantial salvageable penumbra due to a large vessel occlusion before and after endovascular therapy.
Detailed description
This is a single-center, sham-controlled, dose-escalation study where cathodal tDCS is delivered to threatened but not yet irreversibly damaged (penumbral) tissue in patients with large vessel occlusion who are undergoing recanalization procedure. Patients will be randomized in a 3:1 design, to cathodal versus sham (control) stimulation, at each six designed dose tiers. The dose tiers will be increasing in both intensity and duration of the stimulation. All patients will be receiving the first dose (stimulation cycle) after the recanalization procedure and patients at dose tiers 5-6 will also be receiving stimulation cycles before the recanalization procedure begins.
The occurrence of symptomatic intracranial hemorrhage will determine the pace of the escalation through the dose tiers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Traditional 3+3 (rule-based, modified Fibonacci) dose-escalation design
| Arm | Type | Receives |
|---|---|---|
| Stimulation arm | Experimental | Device: Transcranial Direct Current Stimulation (tDCS)Patients will be randomized to active treatment (C-tDCS) vs sham stimulation in a 3:1 ratio. There will be 6 dose tiers: Tier 1 - 1 mA, and Tier 2- 2 mA: Consist of a single stimulation cycle (20min) after the endovascular procedure (EVT) in patients with TICI<2c,3 and negative immediate post-EVT CT scan for definitive evidence of ICH. Tier 3 - 1 mA and Tier 4- 2mA consist of 2 treatment cycles after the EVT in patients with TICI<2c and 3, and negative immediate post-EVT CT scan for definitive evidence of ICH. Tier 5 - 1 mA and tier 6- 2 mA consist of 3 treatment cycles. The first cycle will be up to 20 min cycle, after initial imaging and prior to arterial puncture, the second and third cycles after EVT in patients with TICI<2c and 3 and negative immediate post-EVT CT scan for definitive evidence of ICH. |
| Sham arm | Sham comparator | Device: Transcranial Direct Current Stimulation (tDCS)Patients in the sham stimulation arm at all the tiers will have the cap and electrodes in place, and sham switch moved but without delivery of electrical stimulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- New focal neurologic deficit consistent with AIS
- Age≥18
- NIHSS ≥ 4
- ICA or M1 or M2 MCA occlusion on pre-thrombectomy MRA or CTA
- Onset (last-seen-well) time to randomization time within 24 hours
Key exclusion criteria (10 listed)
- Acute intracranial hemorrhage
- Evidence of a large Ischemic core volume (ADC < 620 µm2/s or rCBF< 30%) ≥ 100 ml
- Presence of tDCS contraindications - electrically or magnetically activated intracranial metal and non-metal implants.
- Pregnancy
- Severe contrast allergy or absolute contraindication to iodinated contrast preventing endovascular intervention.
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 |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS)20 minutes of Cathodal tDCS after +/- before endovascular thrombectomy (EVT) | Device | Sham arm, Stimulation arm |
Primary outcome
Primary Safety Outcome- Number of Participants With Symptomatic Intracranial Hemorrhage (SICH)
Time frame: At 24-hour post-stimulation
Symptomatic intracranial hemorrhage (SICH) is defined as an increase of 4 or more points on the National Institute of Health Stroke Scale (NIHSS) total score within 24 hours of stimulation associated with parenchymal hematoma type 1 (PH1), parenchymal hematoma type 2 (PH2), remote intraparenchymal hemorrhage (RIH), subarachnoid hemorrhage (SAH), or intraventricular hemorrhage (IVH). The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute stroke on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. Accordingly, 0 is the lowest and 42 is the highest total score possible. In the NIHSS, the higher the score, the more impaired a stroke patient is.
Primary Tolerability Outcome-Number of Participants Completing the Protocol-assigned Stimulation
Time frame: After 5 minutes of stimulation period
The percentage of the patients completing the protocol-assigned stimulation treatment with no intolerability.
Primary Feasibility Outcome- Assessing the Speed of Stimulation Implementation From Randomization.
Time frame: Median time from randomization to tDCS initiation
The median times from randomization to bridging C-tDCS initiation and the time form end of endovascular thrombectomy procedure to adjunctive C-tDCS initiation in the last 10 enrolled patients.
4 secondary outcomes
Secondary Safety Outcome-Number of Participants With Asymptomatic Intracranial Hemorrhage (AICH)
Time frame: At 24-hour post-stimulation
Secondary Safety Outcome-Number of Participants With Early Neurologic Deterioration
Time frame: At 24-hour post-stimulation
Secondary Safety Outcome-Number of Participants With Mortality
Time frame: At 90 days post-stimulation
Secondary Safety Outcome-Number of Participants With All Serious Adverse Events (Anticipated and Unanticipated)
Time frame: At 90 days post-stimulation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation (tDCS) in people with Acute Ischemic Stroke, run by University of California, Los Angeles at 1 site 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 10 inclusion and 10 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: stopped early, as of the sponsor's last update on 20 Jul 2023. 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 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. 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?
Yes. Results are posted in the registry (first posted 20 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Primary Safety Outcome- Number of Participants With Symptomatic Intracranial Hemorrhage (SICH) (time frame: At 24-hour post-stimulation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2023; AzTrials last refreshed its copy on 6 Nov 2026.