NCT03574038: TESSERACT

Transcranial Direct Current Stimulation as a Neuroprotection in Acute Stroke

Completed NA Results posted Last updated 27 June 2023

What this trial tests

NA trial testing Transcranial Direct Current Stimulation in Stroke, Acute in 10 participants. Completed in 1 April 2022.

Timeline

28 September 2018

Primary endpoint
1 April 2022

1 April 2022

Quick facts

Lead sponsor	University of California, Los Angeles
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	triple
Primary purpose	treatment
Enrollment	10
Start date	28 September 2018
Primary completion	1 April 2022
Estimated completion	1 April 2022
Sites	1 location across United States

Drugs / interventions tested

• Transcranial Direct Current Stimulation
• Sham Stimulation

Conditions studied

• Stroke, Acute — all drugs for Stroke, Acute →

Sponsor

University of California, Los Angeles

Who can join

18 and older, any sex, with Stroke, Acute. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Safety Outcome: Rate of Symptomatic Intracranial Hemorrhage (SICH) in the Active Treatment Arms Compared to Sham Arm Primary · At 24-hour post-stimulation

The presence of SICH will be assessed on 24-hour post-stimulation scan. SICH will be defined as an intracranial parenchymal hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage with an increase of 4 or more points on the National Institute of Health Stroke Scale (NIHSS) within 24 hours of stimulation.The treatment will be considered to have exhibited adequate safety if tDCS results in lower or equivalent rates of SICH compared to sham. The NIHSS is a validated quantitative assessment tool to measure stroke-related neurological deficits and ranges from 0 (no neurological deficit

Group	Value	95% CI
Active Stimulation-Tier 1	0
Active Stimulation-Tier 2	1
Sham Stimulation	0

Feasibility Outcome: Speed With Which HD C-tDCS Was Implemented Primary · Time from randomization to tDCS initiation assessed up to 30 minutes

The median time from enrollment to HD C-tDCS initiation in the last 4 enrolled patients included three Active-Tier 2 patients and one sham.

Group	Value	95% CI
Active Stimulation and Sham	12.5	9 – 15

Tolerability Outcome: Percentage of the Patients Completing the Protocol-assigned Stimulation Treatment Primary · After 20 minutes of stimulation period

Percentage of the patients completing the protocol-assigned stimulation treatment

Group	Value	95% CI
Active Stimulation-Tier 1	3
Active Stimulation-Tier 2	4
Sham Stimulation	3

Secondary Safety Outcome: Rate of Early Neurologic Deterioration in All Active Patients Compared to Sham Arm Secondary · During the 24-hour post-stimulation

Early neurological deterioration will be defined as worsening ≥ 4 on NIHSS during the 24-hour period after stimulation without intracranial hemorrhage.

Group	Value	95% CI
Active Stimulation (Tier 1 and 2)	1
Sham Stimulation	0

Secondary Safety Outcome: Rate of Mortality in All Active Patients Compared to Sham Arm, Secondary · By day 90 post stimulation

Mortality will be defined as death or modified Rankin Scale of 6.

Group	Value	95% CI
Active Stimulation (Tier 1 and 2)	2
Sham Stimulation	1

Secondary Safety Outcome: Rate of All Serious Adverse Events Occured During the 90 Days of Study Participation in All Active Patients Compared to Sham. Secondary · By day 90 post-stimulation

A serious adverse event 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. The rate of serious adverse events will be compared between the active treatment and sham patients.

Group	Value	95% CI
Active Stimulation (Tier 1 and 2)	3
Sham Stimulation	2

Per-protocol Exploratory Imaging Efficacy Outcome of Imaging Biomarkers of Neuroprotection and Collateral Enhancement Excluding One Patient With no Penumbra at Baseline on Imaging Core Review and One Patient With Septic Embolization as Stroke Cause. Secondary · At 2-hour and 24-hour post-stimulation

By comparing the baseline MR/CT imaging with the MR/CT imaging at 2-hour (early) and 24-hour (final) post-stimulation, the following were measured: 1) Final penumbra salvage proportion, 2) Final hypoperfusion lesion reduction, 3) Early relative quantitative cerebral blood volume (qrCBV) enhancement.

Final penumbra salvage proportion percentage

Group	Value	95% CI
Transcranial Direct Current Stimulation	66	29 – 80.5
Sham Stimulation	0	0 – 0

Final hypoperfusion lesion proportion percentage change

Group	Value	95% CI
Transcranial Direct Current Stimulation	-100	-100 – -46
Sham Stimulation	325	112 – 412

Early qrCBV percentage change

Group	Value	95% CI
Transcranial Direct Current Stimulation	64	40 – 110
Sham Stimulation	-4	-7 – 1

Per-protocol Exploratory Clinical Efficacy Outcome: Rate of Functional Independence at 3-month in Active vs. Sham Excluding Two Patients, One With no Penumbra Was Present at Baseline on Imaging Core Review and One With Septic Embolization as Stroke Cause. Secondary · At day 90 post stimulation

Rate of modified Rankin Scale (mRS) of 0-2

Group	Value	95% CI
Active Stimulation (Tier 1 and 2)	3
Sham Stimulation	2

Adverse events — posted to ClinicalTrials.gov

Time frame: Three months following the study enrollment. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Active Stimulation-Tier 1

Serious: 1/3 (33%)

Deaths: 0/3

Active Stimulation-Tier 2

Serious: 2/4 (50%)

Deaths: 2/4

Sham Stimulation

Serious: 2/3 (67%)

Deaths: 1/3

Serious adverse events (2 terms)

Reaction	System	Active Stimulation-Tier 1	Active Stimulation-Tier 2	Sham Stimulation
Anticipated serious adverse events	Nervous system disorders	—	—	—
Unanticipated serious adverse event	Nervous system disorders	—	—	—

Other adverse events (2 terms — click to expand)

Reaction	System	Active Stimulation-Tier 1	Active Stimulation-Tier 2	Sham Stimulation
Anticipated AE	Nervous system disorders	—	—	—
Unanticipated adverse event	Nervous system disorders	—	—	—

Most-reported serious reactions: Anticipated serious adverse events, Unanticipated serious adverse event.

Data from ClinicalTrials.gov NCT03574038 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke.
   Elsner B, Kugler J, Pohl M, Mehrholz J. · · 2020 · cited 80× · PMID 33175411 · DOI 10.1002/14651858.cd009645.pub4
2. High-definition Cathodal Direct Current Stimulation for Treatment of Acute Ischemic Stroke: A Randomized Clinical Trial.
   Bahr-Hosseini M, Nael K, Unal G, Iacoboni M, et al · · 2023 · cited 25× · PMID 37342040 · DOI 10.1001/jamanetworkopen.2023.19231
3. From Molecule to Patient Rehabilitation: The Impact of Transcranial Direct Current Stimulation and Magnetic Stimulation on Stroke-A Narrative Review.
   Badoiu A, Mitran SI, Catalin B, Balseanu TA, et al · · 2023 · cited 9× · PMID 36895285 · DOI 10.1155/2023/5044065