N/A
N=10
Transcranial Direct Current Stimulation as a Neuroprotection in Acute Stroke
Stroke, Acute
Bottom Line
View on ClinicalTrials.gov: NCT03574038 ↗Enrolled (actual)
10
Serious AEs
50.0%
Results posted
Jun 2023
Primary outcome: Primary: Safety Outcome: Rate of Symptomatic Intracranial Hemorrhage (SICH) in the Active Treatment Arms Compared to Sham Arm — 0; 1; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcranial Direct Current Stimulation (Device); Sham Stimulation (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Los Angeles
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety Outcome: Rate of Symptomatic Intracranial Hemorrhage (SICH) in the Active Treatment Arms Compared to Sham Arm |
0; 1; 0 | — |
| PRIMARY Feasibility Outcome: Speed With Which HD C-tDCS Was Implemented |
12.5 | — |
| PRIMARY Tolerability Outcome: Percentage of the Patients Completing the Protocol-assigned Stimulation Treatment |
3; 4; 3 | — |
| SECONDARY Secondary Safety Outcome: Rate of Early Neurologic Deterioration in All Active Patients Compared to Sham Arm |
1; 0 | — |
| SECONDARY Secondary Safety Outcome: Rate of Mortality in All Active Patients Compared to Sham Arm, |
2; 1 | — |
| SECONDARY Secondary Safety Outcome: Rate of All Serious Adverse Events Occured During the 90 Days of Study Participation in All Active Patients Compared to Sham. |
3; 2 | — |
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 who are ineligible for intravenous thrombolysis and endovascular therapy.
Eligibility Criteria
Inclusion criteria
- New focal neurologic deficit consistent with AIS
- NIHSS≥4 or NIHSS 18;
- Presence of any cortical vessel occlusion including ICA, branches of MCA, Anterior Cerebral artery (ACA), Posterior Cerebral artery (PCA), Posterior-Inferior cerebellar artery (PICA);
- Presence of salvageable penumbra with Tmax> 6 sec/ ischemic core volume (ADC 1), mild neurological symptoms (NIHSS <6), large ischemic core (ASPECTS <6), thrombectomy not technically performable due to severe vessel tortuosity, cervical artery chronic occlusion, or other unfavorable angioarchitectural features that preclude endovascular access to the target intracranial vessel. 8) Subject is able to be treated with tDCS within 24 hours of last known well time;
- A signed informed consent is obtained from the patient or patient's legally authorized representative
Exclusion criteria
- Acute intracranial hemorrhage
- Evidence of a large Ischemic core volume (ADC < 620 μm2/s or rCBF< 30%) ≥ 100
- Presence of tDCS contraindications - electrically or magnetically activated intracranial metal and non-metal implants.
- Severe MR contrast allergy or renal dysfunction with eGFR<30ml/min, precluding MRI gadolinium or CT iodine contrast
- Pregnancy
- Signs or symptoms of acute myocardial infarction, including EKG findings, on admission
- Suspicion of aortic dissection on admission
- History of seizure disorder or new seizures with presentation of current stroke
- 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 platelet count of ≤ 100, INR ≥ 3, PTT ≥ 90.
Data sourced from ClinicalTrials.gov (NCT03574038). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.