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tACS to Enhance Language Abilities

Sponsor
University of Pennsylvania (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06092814
Collaborator
(none)
120
Enrollment
1
Location
2
Arms
55.8
Anticipated Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Active transcranial alternating current stimulation (tACS)
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
The proposed study is a within-subject, double-blind & sham-controlledThe proposed study is a within-subject, double-blind & sham-controlled
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Transcranial Alternating Current Stimulation (tACS) to Enhance Language Abilities
Anticipated Study Start Date :
Nov 6, 2023
Anticipated Primary Completion Date :
Jun 30, 2028
Anticipated Study Completion Date :
Jun 30, 2028

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: real-tACS

The active stimulation will consist of an alternating current delivered in the alpha frequency band with a peak-to-peak intensity of 4 milliamps (mA) for 20 minutes. Participants will complete sentence completion and verb generation task during stimulation.

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.
Other Names:
  • Sham transcranial alternating current stimulation [(ACS)

    		•
    Placebo Comparator: sham-tACS

    Sham stimulation involves the delivery of 60 seconds of the actual stimulation waveform ("ramp up") which is then gradually reduced to 0 milliamps (mA) ("ramp down"). Participants will complete sentence completion and verb generation task during stimulation.

    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.
    Other Names:
  • Sham transcranial alternating current stimulation [(ACS)

    		•

    Outcome Measures

    Primary Outcome Measures

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

      The BCN tasks involves naming a set of pictures repeatedly. Sets of pictures come from either the same semantic category (high competition condition; e.g., categorically related: "dog", "cat", "panda") or different semantic categories (low competition condition; e.g., unrelated: dog, eye, crib).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria for Persons with Aphasia:

    1. Presence of aphasia

    2. Suffered a single, left hemisphere stroke

    3. Stroke ≥6 months old (chronic) at the time of enrollment

    Inclusion Criteria for Healthy Controls:

    1. Right-handedness

    2. Must be able to understand the nature of the study, and give informed consent

    Exclusion criteria for Persons with Aphasia:

    1. Inability to understand the nature of the study

    2. Marked naming impairment

    3. Impaired non-verbal, conceptual processing

    4. History of significant medical or neurological disorder (other than stroke)

    5. History of significant or poorly controlled psychiatric disorders

    6. Current abuse of alcohol or drugs, prescription or otherwise

    7. Nursing a child, pregnancy, or intent to become pregnant during the study

    8. Clinically significant hearing loss

    9. Contraindications to tACS

    10. Contraindications to MRI

    Exclusion Criteria for Healthy Controls

    1. Diagnosis of a neurodegenerative disease or clinically significant cognitive complaint

    2. Any unrelated neurologic or physical condition that impairs communication ability

    3. 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

    4. 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

    5. A medically unstable cardiopulmonary or metabolic disorder

    6. Terminal illness associated with survival <12 months

    7. Major active psychiatric illness that may interfere with required study procedures or treatments as determined by the enrolling physician

    8. Current abuse of alcohol or drugs, prescription or otherwise

    9. Contraindications to tACS

    10. Contraindications to MRI

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Pennsylvania Philadelphia Pennsylvania United States 19104

    Sponsors and Collaborators

    • University of Pennsylvania

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Pennsylvania
    ClinicalTrials.gov Identifier:
    NCT06092814
    Other Study ID Numbers:
    • 854139
    First Posted:
    Oct 23, 2023
    Last Update Posted:
    Oct 23, 2023
    Last Verified:
    Oct 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Pennsylvania
    non-invasive brain stimulation
    transcranial alternating current stimulation (tACS)
    EEG
    Additional relevant MeSH terms:
    Aphasia

    Study Results

    No Results Posted as of Oct 23, 2023