NCT05194566

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Sep 2023Dec 2026

First Submitted

Initial submission to the registry

January 4, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 18, 2022

Completed
1.6 years until next milestone

Study Start

First participant enrolled

September 6, 2023

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

3.2 years

First QC Date

January 4, 2022

Last Update Submit

February 13, 2026

Conditions

Post-stroke Aphasia

Keywords

speech therapybrain stimulationcommunicationlanguage

Outcome Measures

Primary Outcomes (1)

  • Percentage score in the Naming Task (trained words)

    The Baseline Naming Task consists of 344 images representing nouns and the images will be presented on the computer screen. The task is to name the presented noun by producing the name of the item out loud. The answer is scored on a three-point scale (1 - not able to name correctly, 2 - named with phonological or semantic paraphasia, 3 - correct). Items marked with a score of 3 are considered accurate. From the baseline assessment, a random list of 50 incorrectly named words will be trained in therapy. Minimum score is 0% (inability to name any objects) and maximum score is 100% (accuracy in naming all presented objects), where a higher score indicates a better health outcome

    12-week follow-up

Secondary Outcomes (12)

  • Percentage score in the Naming Task (trained words)

    immediately after the intervention and 6-week follow-up

  • Number of correct answers without supporting cues

    during treatment sessions

  • Accuracy of naming during the therapy session

    during treatment sessions

  • Percentage Score in Naming Task (untrained words)

    immediately after the intervention, 6-week and 12-week follow-up

  • Communication Effectiveness Index (CETI)

    pre-treatment, immediately after the intervention, 6-week and 12-week follow-up

  • +7 more secondary outcomes

Study Arms (2)

Real tACS

ACTIVE COMPARATOR

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

Device: tACS

Sham tACS

SHAM COMPARATOR

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

Device: tACS

Interventions

tACSDEVICE

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.

Also known as: transcranial alternating current stimulation
Real tACSSham tACS

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%.
  • years
  • right-handedness before the stroke.
  • ability to give informed written consent.
  • fluency in English.

You may not qualify if:

  • 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)
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Think & Speak Lab at Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

RECRUITING

Abilities Research Center at Mount Sinai

New York, New York, 10029, United States

RECRUITING

Related Publications (1)

  • Fridriksson J, Elm J, Stark BC, Basilakos A, Rorden C, Sen S, George MS, Gottfried M, Bonilha L. BDNF genotype and tDCS interaction in aphasia treatment. Brain Stimul. 2018 Nov-Dec;11(6):1276-1281. doi: 10.1016/j.brs.2018.08.009. Epub 2018 Aug 18.

    PMID: 30150003BACKGROUND

MeSH Terms

Conditions

Communication DisordersCommunicationLanguage

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Miguel Escalon, MD, MPH

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tertia Jeppson

CONTACT

312-238-6163tjeppson@sralab.org

Aidan Rogers

CONTACT

(718) 308-9450aidan.rogers@mountsinai.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participant, investigator and outcomes assessor are all blinded. Designated research team members will be unblinded in order to manage computerized procedure.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study will employ a between-subject randomized sham-controlled design.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2022

First Posted

January 18, 2022

Study Start

September 6, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

February 18, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Not applicable to study aims

Locations

US(2)