StrokeDICAST-SFNCT04801446
Transcranial Direct Current Stimulation in Acute Ischemic Stroke Treatment
A study testing Soterix Medical 1X1 tDCS stimulator (active C-tDCS) in people with Stroke, run by General University Hospital, Prague at 1 site in Czechia.
Trial summary
This prospective interventional single center randomized sham controlled dose-escalation study will assess safety, tolerability, feasibility and potential efficacy of transcranial direct current stimulation (tDCS) in acute stroke patients with substantial salvageable penumbra due to a large vessel occlusion who are… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Soterix Medical 1X1 tDCS stimulator (active C-tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteCzechia
- Study dates
- 10 May 2021to 10 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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.
- New focal neurologic deficit consistent with acute ischemic stroke.
- Baseline NIHSS ≥ 4 or NIHSS < 4 in the presence of disabling deficits (e.g. aphasia)
- Presence of acute occlusion of ICA or MCA (including MCA peripheral cortical branches) according to clinical picture and baseline CTA/CTP scan.
- Presence of salvageable penumbra with Tmax > 6 sec/ ischemic core volume (rCBF < 30%) ≥ 1.2 on baseline CTP scan.
- Patient is ineligible for EVT per current national guidelines (Cerebrovascular Section of Czech Neurological Society ČLS JEP).
- 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 (point 30 of Declaration of Helsinki).
Who cannot join
- Acute intracranial hemorrhage including suspected subarachnoid hemorrhage.
- Other than ischemic cause of acute neurological deficit (stroke mimics:postparoxysmal Todd´s palsy, metabolic cause, tumor, meningoencephalitis etc.).
- Evidence of a large Ischemic core volume on baseline CTP: volume of rCBF<30% ≥ 100ml.
- Subacute or chronic subdural hematoma or hygroma.
- Intra-axial malignant brain tumor.
- History of spontaneous ICH in the past.
Show all 21Show fewer
- History of seizure disorder or new seizures with presentation of current stroke.
- History of intracranial surgery.
- Presence of tDCS contraindications: skin lesion at the site of stimulation (open wound, acute inflammation of skin or subcutaneous tissue, burns etc.); skull defect at the site of stimulation (e.g. skull fracture, postcraniectomy); implanted electric device (pacemaker, ICD, DBS, cochlear implant etc.); presence of metal material in head (e.g. metal stent, clamps etc.).
- Thrombocytopenia < 100 000/ul.
- INR > 3,0.
- Heparin or LMWH therapy in last 48 hours with aPTT increased more than 1,5 times over limit of the laboratory.
- History of acute overdose by DOAC.
- Known congenital or acquired increased bleeding propensity.
- Suspected or confirmed pregnancy.
- Known CT iodine contrast allergy.
- Known renal dysfunction (eGFR<30 ml/min.).
- Signs or symptoms of acute myocardial infarction, including ECG findings, on admission.
- Suspicion of aortic dissection on admission.
- 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.
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Department of Neurology, General University Hospital in Prague
Prague, 12000
About this study
Official title: Transcranial Direct Current Stimulation in Acute Ischemic Stroke Treatment - Safety and Feasibility Trial
This prospective interventional single center randomized sham controlled dose-escalation study will assess safety, tolerability, feasibility and potential efficacy of transcranial direct current stimulation (tDCS) in acute stroke patients with substantial salvageable penumbra due to a large vessel occlusion who are ineligible for endovascular therapy (EVT). Patients will be randomized in a 3:1 design, to cathodal versus sham (control) tDCS, at each six designed dose tiers. The dose tiers will be increasing in both intensity and duration of the stimulation. The occurrence of symptomatic intracranial hemorrhage will determine the pace of the escalation through the dose tiers.
- Conditions
- Stroke
- Being tested
- Soterix Medical 1X1 tDCS stimulator (active C-tDCS), Soterix Medical 1X1 tDCS stimulator (sham stimulation)
- Keywords
- stroke, transcranial direct current stimulation, tDCS, neuroprotection
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soterix Medical 1X1 tDCS stimulator (active C-tDCS)Device
Patients will be randomized to active treatment (C-tDCS) vs sham stimulation in a 3:1 ratio. There will be 6 dose tiers, reflecting increasing intensity and duration of stimulation: Tier 1 - 1 mA, single 20 - min cycle; Tier 2- 2 mA, single 20 min cycle; Tier 3 - 1 mA, 2 cycles of 20 min/20 min off; Tier 4- 2 mA, 2 cycles of 20 min/20 min off; Tier 5 - 1 mA, 3 cycles of 20 min/20 min off; Tier 6 - 2 mA, 3 cycles of 20 min/20 min off.
Soterix Medical 1X1 tDCS stimulator (sham stimulation)Device
Patients will be randomized to active treatment (C-tDCS) vs sham stimulation in a 3:1 ratio. Patients in the sham stimulation arm at all the tiers will have the headgear and electrodes in place, and the switch for sham stimulation will be on, i.e. no prolonged electrical stimulation will be delivered.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Direct Current Stimulation | Active comparator | Not described Receives: Device: Soterix Medical 1X1 tDCS stimulator (active C-tDCS) |
| Sham Stimulation | Sham comparator | Not described Receives: Device: Soterix Medical 1X1 tDCS stimulator (sham stimulation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary safety outcome: the rate of symptomatic intracranial hemorrhage (SICH) in the active treatment arm compared to sham arm, and between higher and lower dose tiers.
The presence of SICH will be assessed on 24-hour post-stimulation non-contrast CT scan. SICH will be defined as an intracranial hemorrhage with an increase of ≥ 4 points on the National Institute of Health Stroke Scale (NIHSS) within 24h after stimulation. In case of sudden worsening of neurostatus anytime within first 24 hours after stimulation, first follow-up CT will be performed immediately (earlier). The treatment will be considered to have exhibited adequate safety if tDCS results in lower or equivalent rates of SICH compared to sham.
Measured: At 24-hour post-stimulation
Secondary outcomes (4)
Secondary safety outcome: the rate of asymptomatic intracranial hemorrhage (AICH) in the active treatment arm compared to sham arm, and between higher and lower dose tiers.
The AICH will be defined as an intracranial hemorrhage on 24h post-stimulation non-contrast CT scan that is not associated with NIHSS worsening ≥ 4 within 24 hours after stimulation.The treatment will be considered to have exhibited adequate safety if tDCS results in lower or equivalent rates of AICH compared to sham.
Measured: At 24-hour post-stimulation
Secondary safety outcome: the rate of early neurologic deterioration in the active treatment arm compared to sham arm, and between higher and lower dose tiers.
Early neurological deterioration will be defined as worsening ≥ 4 on NIHSS during the 24-hour period after stimulation without intracranial hemorrhage. The treatment will be considered to have exhibited adequate safety if tDCS results in lower or equivalent rates of early neurological deterioration compared to sham.
Measured: During the 24-hour post-stimulation
Secondary safety outcome: the rate of mortality in the active treatment arm compare to sham arm, and between higher and lower dose tiers.
Mortality will be defined as death or modified Rankin Scale of 6. The treatment will be considered to have exhibited adequate safety if tDCS results in lower or equivalent rates of mortality compared to sham.
Measured: By day 90 post stimulation
Secondary safety outcome: the rate of all serious adverse events occurring during the 90 days of study participation in the active treatment arm compare to sham arm, and between higher and lower dose tiers.
A serious adverse event is any adverse event that is fatal, is lifethreatening, is permanently or substantially disabling, requires or prolongs hospitalization, or requires medical or surgical intervention to prevent one of the above outcomes. The rate of serious adverse events will be compared between the active treatment and sham patients, and between higher and lower dose tiers.The treatment will be considered to have exhibited adequate safety if tDCS results in lower or equivalent rates of serious adverse events compared to sham.
Measured: By day 90 post-stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start10 May 2021
- Primary completion13 Nov 2023
- Study completion10 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Sequential
- Model description
- Traditional 3+3 (rule-based, modified Fibonacci) dose escalation design
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- General University Hospital, Prague
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matej Slovak, General University Hospital, Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04801446
- Sponsor's protocol ID
- 1786/20 S-IV
- Acronym
- DICAST-SF
- Status last verified
- Aug 2024
- First submitted
- 5 Jan 2021
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Slovak M, Kemlink D, Dusek P, Rekova P, Fabian V, Jurka M, Carone D, Perry A, Harston GWJ, Ruzicka E, Altmanova D, Lambert L, Burgetova A, Knotkova H, Datta A, Bikson M, Nitsche MA, Bahr-Hosseini M, Saver JL. Transcranial direct current stimulation is safe and feasible in hyperacute ischemic stroke (DICAST-SF trial). Neurotherapeutics. 2026 Jan;23(1):e00844. doi: 10.1016/j.neurot.2026.e00844. Epub 2026 Feb 1.
PubMed 41629171
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation in Acute Ischemic Stroke Treatment - Safety and Feasibility Trial
- ClinicalTrials.gov ID
- NCT04801446
- Acronym / sponsor ID
- DICAST-SF / 1786/20 S-IV
- Conditions
- Stroke
- Keywords
- stroke, transcranial direct current stimulation, tDCS, neuroprotection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- General University Hospital, PragueUniversity, hospital or other
- Study start
- 10 May 2021 (actual)
- Primary completion
- 13 Nov 2023 (actual)
- Study completion
- 10 Feb 2024 (actual)
- First posted
- 17 Mar 2021 (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.
This prospective interventional single center randomized sham controlled dose-escalation study will assess safety, tolerability, feasibility and potential efficacy of transcranial direct current stimulation (tDCS) in acute stroke patients with substantial salvageable penumbra due to a large vessel occlusion who are ineligible for endovascular therapy (EVT). Patients will be randomized in a 3:1 design, to cathodal versus sham (control) tDCS, at each six designed dose tiers. The dose tiers will be increasing in both intensity and duration of the stimulation. 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
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Traditional 3+3 (rule-based, modified Fibonacci) dose escalation design
| Arm | Type | Receives |
|---|---|---|
| Transcranial Direct Current Stimulation | Active comparator | Device: Soterix Medical 1X1 tDCS stimulator (active C-tDCS) |
| Sham Stimulation | Sham comparator | Device: Soterix Medical 1X1 tDCS stimulator (sham stimulation) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age > 18 years.
- New focal neurologic deficit consistent with acute ischemic stroke.
- Baseline NIHSS ≥ 4 or NIHSS < 4 in the presence of disabling deficits (e.g. aphasia)
- Presence of acute occlusion of ICA or MCA (including MCA peripheral cortical branches) according to clinical picture and baseline CTA/CTP scan.
- Presence of salvageable penumbra with Tmax > 6 sec/ ischemic core volume (rCBF < 30%) ≥ 1.2 on baseline CTP scan.
Key exclusion criteria (21 listed)
- Acute intracranial hemorrhage including suspected subarachnoid hemorrhage.
- Other than ischemic cause of acute neurological deficit (stroke mimics:postparoxysmal Todd´s palsy, metabolic cause, tumor, meningoencephalitis etc.).
- Evidence of a large Ischemic core volume on baseline CTP: volume of rCBF<30% ≥ 100ml.
- Subacute or chronic subdural hematoma or hygroma.
- Intra-axial malignant brain tumor.
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 |
|---|---|---|
| Soterix Medical 1X1 tDCS stimulator (active C-tDCS)Patients will be randomized to active treatment (C-tDCS) vs sham stimulation in a 3:1 ratio. There will be 6 dose tiers, reflecting increasing intensity and duration of stimulation: Tier 1 - 1 mA, single 20 - min cycle; Tier 2- 2 mA, single 20 min cycle; Tier 3 - 1 mA, 2 cycles of 20 min/20 min off; Tier 4- 2 mA, 2 cycles of 20 min/20 min off; Tier 5 - 1 mA, 3 cycles of 20 min/20 min off; Tier 6 - 2 mA, 3 cycles of 20 min/20 min off. | Device | Transcranial Direct Current Stimulation |
| Soterix Medical 1X1 tDCS stimulator (sham stimulation)Patients will be randomized to active treatment (C-tDCS) vs sham stimulation in a 3:1 ratio. Patients in the sham stimulation arm at all the tiers will have the headgear and electrodes in place, and the switch for sham stimulation will be on, i.e. no prolonged electrical stimulation will be delivered. | Device | Sham Stimulation |
Primary outcome
Primary safety outcome: the rate of symptomatic intracranial hemorrhage (SICH) in the active treatment arm compared to sham arm, and between higher and lower dose tiers.
Time frame: At 24-hour post-stimulation
The presence of SICH will be assessed on 24-hour post-stimulation non-contrast CT scan. SICH will be defined as an intracranial hemorrhage with an increase of ≥ 4 points on the National Institute of Health Stroke Scale (NIHSS) within 24h after stimulation. In case of sudden worsening of neurostatus anytime within first 24 hours after stimulation, first follow-up CT will be performed immediately (earlier). The treatment will be considered to have exhibited adequate safety if tDCS results in lower or equivalent rates of SICH compared to sham.
4 secondary outcomes
Secondary safety outcome: the rate of asymptomatic intracranial hemorrhage (AICH) in the active treatment arm compared to sham arm, and between higher and lower dose tiers.
Time frame: At 24-hour post-stimulation
Secondary safety outcome: the rate of early neurologic deterioration in the active treatment arm compared to sham arm, and between higher and lower dose tiers.
Time frame: During the 24-hour post-stimulation
Secondary safety outcome: the rate of mortality in the active treatment arm compare to sham arm, and between higher and lower dose tiers.
Time frame: By day 90 post stimulation
Secondary safety outcome: the rate of all serious adverse events occurring during the 90 days of study participation in the active treatment arm compare to sham arm, and between higher and lower dose tiers.
Time frame: By day 90 post-stimulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Derived from this study: PubMed 41629171Slovak M, Kemlink D, Dusek P, Rekova P, Fabian V, Jurka M, Carone D, Perry A, Harston GWJ, Ruzicka E, Altmanova D, Lambert L, Burgetova A, Knotkova H, Datta A, Bikson M, Nitsche MA, Bahr-Hosseini M, Saver JL. Transcranial direct current stimulation is safe and feasible in hyperacute ischemic stroke (DICAST-SF trial). Neurotherapeutics. 2026 Jan;23(1):e00844. doi: 10.1016/j.neurot.2026.e00844. Epub 2026 Feb 1.
- Individual participant dataSharing planned: No
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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 Soterix Medical 1X1 tDCS stimulator (active C-tDCS) in people with Stroke, run by General University Hospital, Prague at 1 site in Czechia.
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 8 inclusion and 21 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: finished, as of the sponsor's last update on 6 Aug 2024. 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 Czechia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: the rate of symptomatic intracranial hemorrhage (SICH) in the active treatment arm compared to sham arm, and between higher and lower dose tiers. (time frame: At 24-hour post-stimulation). 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 NCT04801446, which also lists 1 linked publication.
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 6 Aug 2024.