NCT06092814

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P75+ for not_applicable stroke

Timeline
28mo left

Started Jul 2024

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress44%
Jul 2024Aug 2028

First Submitted

Initial submission to the registry

September 28, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
9 months until next milestone

Study Start

First participant enrolled

July 12, 2024

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2028

Last Updated

August 8, 2025

Status Verified

August 1, 2025

Enrollment Period

4.1 years

First QC Date

September 28, 2023

Last Update Submit

August 4, 2025

Conditions

Keywords

non-invasive brain stimulationtranscranial alternating current stimulation (tACS)EEG

Outcome Measures

Primary Outcomes (1)

  • Performance on the Blocked-Cyclic Naming (BCN) Task

    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).

    5-10 minutes after a single session of active (alpha tACS) and sham (fake tACS).

Study Arms (2)

real-tACS

ACTIVE COMPARATOR

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)

sham-tACS

PLACEBO COMPARATOR

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)

Interventions

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

Also known as: Sham transcranial alternating current stimulation [(ACS)
real-tACSsham-tACS

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Presence of aphasia
  • Suffered a single, left hemisphere stroke
  • Stroke ≥6 months old (chronic) at the time of enrollment
  • Right-handedness
  • Must be able to understand the nature of the study, and give informed consent

You may not qualify if:

  • 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
  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

StrokeAphasia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSpeech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: The proposed study is a within-subject, double-blind \& sham-controlled
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2023

First Posted

October 23, 2023

Study Start

July 12, 2024

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

August 31, 2028

Last Updated

August 8, 2025

Record last verified: 2025-08

Locations