Recruiting

Neurostimulation

Sponsor:

QVITI S.A.

Code:

NCT05194566

Conditions

Post-stroke Aphasia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

tACS

Study Details

Brief summary:

The aim of the trial is to determine whether 75Hz transcranial alternating current stimulation (tACS) synchronized with therapeutic linguistic tasks is an effective form of therapy for post-stroke aphasia.

Conditions

Post-stroke Aphasia

Study ID

NCT05194566

Start date

Sep 6, 2023

Status verified date

Feb, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Individuals with aphasia (assessed using the Boston Diagnostic Aphasia Examination) who perform the Naming Task in the range of 10%-60% accuracy will be included in the study. The overall baseline score in the Naming Task will be estimated from the two baseline measurements.

Inclusion Criteria:

  • diagnosis of aphasia: Broca's or mixed (based on the assessment of a Speech Language Pathologist).
  • presence of a focus of injury in the left hemisphere (within one hemisphere only) as a result of the first ischemic or hemorrhagic stroke (based on CT/MRI examination);
  • chronic stage of the disease - time since the stroke occurred over 6 months.
  • ability to achieve an accuracy in the Naming Task of 10-60%.
  • 18-80 years
  • right-handedness before the stroke.
  • ability to give informed written consent.
  • fluency in English.

Exclusion Criteria:

  • severe cognitive, auditory or visual impairment that would preclude cognitive and language testing - inability to follow a two-step command.
  • presence of metal implants in the skull.
  • presence of major untreated or unstable psychiatric disease.
  • history of epilepsy or seizures.
  • ongoing medication that increases the risk of epileptic seizures.
  • presence in the body of cardiac stimulator, pacemaker or vagus nerve stimulator (implanted).
  • history of speech, language, hearing, or intellectual disability during childhood.
  • pregnancy (based on declarations)

Exclusion criteria during the trial:

  • high intolerance to stimulation.
  • occurrence of an epileptic seizure.
  • other previously absent neurological or mental symptoms

Withdrawal criteria:

  • high intolerance to stimulation (participants experience severe discomfort during stimulation);
  • occurrence of an epileptic seizure;
  • other previously absent neurological, physical or mental symptoms.

Study Design

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Real tACS

tACS 75Hz intervention combined with language tasks and breathing exercises. The device will operate in tACS research active stimulation mode.

sham comparator: Sham tACS

tACS sham intervention combined with language tasks and breathing exercises. The device will operate in tACS sham simulation research mode.

Interventions

tACS

Neurostimulation will be done using the Neuro Device tCS, which is a certified transcranial electrical stimulator. The device consists of a stimulator with a touch screen, two electrodes and a soft, flexible cap to ensure stability of the electrodes on the head.

Primary outcome measure

  • Percentage score in the Naming Task (trained words) [ Time Frame: 12-week follow-up ]

Central Contacts and Locations

Locations

Think & Speak Lab at Shirley Ryan AbilityLab

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Tertia Jeppson, M.A., CCC-SLP, CBIS

312-238-6163tjeppson@sralab.org

Principal Investigator:

Leora Cherney, PhD, CCC-SLP, BC-ANCDS, FACRM

Abilities Research Center at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Principal Investigator:

Miguel Escalon, MD, MPH

More Information

Sponsor

QVITI S.A.

Last update posted

Feb 18, 2026

Last verified

Feb, 2026

Keywords

  • speech therapy
  • brain stimulation
  • communication
  • language

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by QVITI S.A. on 2026-02-18.