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Recruiting NCT06092814

tACS to Enhance Language Abilities

No phase Interventional Stroke Aphasia, Acquired Aphasia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Active transcranial alternating current stimulation (tACS).
Who it may be relevant to
Registry conditions: Stroke, Aphasia, Acquired, Aphasia. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Transcranial Alternating Current Stimulation (tACS) to Enhance Language Abilities

Overview

The goal of this study is to see if transcranial alternating current stimulation (tACS) can be used to enhance language abilities in people with post-stroke aphasia. Participants will receive real and sham tACS in conjunction with various language tests. Researchers will compare the post-stroke aphasia group with aged matched controls to see if brain response to tACS differs between groups.

Detailed description

This research will investigate whether transcranial alternating current stimulation (tACS), a form of noninvasive brain stimulation, can be used to enhance language abilities in people with aphasia (PWA) due to stroke and healthy older adults when compared to placebo (sham) tACS. The investigators hypothesize that alpha vs. sham tACS will improve language abilities. In addition, the investigators propose that alpha vs. sham tACS will increase local alpha power as well as alpha-induced functional connectivity, and the degree to which alpha tACS increases will be related to the degree of language performance improvement. Finally, the investigators hypothesize that PWA will exhibit abnormalities in alpha-related activity when compared to matched controls, and aphasia severity will be associated with the degree of PWA dysfunction in alpha power and alpha-driven functional connectivity.

Interventions

  • Device Active transcranial alternating current stimulation (tACS)
    Transcranial Alternating Current Stimulation (tACS) is a device that applies a low-intensity electrical current to the brain through electrodes on the scalp.

Primary outcome measures

  • Performance on the Blocked-Cyclic Naming (BCN) Task [Time frame: 5-10 minutes after a single session of active (alpha tACS) and sham (fake tACS).]

Eligibility criteria

Inclusion Criteria for Persons with Aphasia:

  • Presence of aphasia
  • Suffered a single, left hemisphere stroke
  • Stroke ≥6 months old (chronic) at the time of enrollment

Inclusion Criteria for Healthy Controls:

  • Right-handedness
  • Must be able to understand the nature of the study, and give informed consent

Exclusion criteria for Persons with Aphasia:

  • Inability to understand the nature of the study
  • Marked naming impairment
  • Impaired non-verbal, conceptual processing
  • History of significant medical or neurological disorder (other than stroke)
  • History of significant or poorly controlled psychiatric disorders
  • Current abuse of alcohol or drugs, prescription or otherwise
  • Nursing a child, pregnancy, or intent to become pregnant during the study
  • Clinically significant hearing loss
  • Contraindications to tACS
  • Contraindications to MRI

Exclusion Criteria for Healthy Controls

  • Diagnosis of a neurodegenerative disease or clinically significant cognitive complaint
  • Any unrelated neurologic or physical condition that impairs communication ability
  • History of unrelated neurological conditions including but not limited to traumatic brain injury, stroke, or small vessel disease that has resulted in a neurologic deficit
  • Any additional neurological condition that would likely reduce the safety of study participation, including central nervous system (CNS) vasculitis, intracranial tumor, intracranial aneurysm, multiple sclerosis or arteriovenous malformations
  • A medically unstable cardiopulmonary or metabolic disorder
  • Terminal illness associated with survival <12 months
  • Major active psychiatric illness that may interfere with required study procedures or treatments as determined by the enrolling physician
  • Current abuse of alcohol or drugs, prescription or otherwise
  • Contraindications to tACS
  • Contraindications to MRI

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Pennsylvania — Philadelphia

Identifiers

NCT: NCT06092814 · 854139

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗