tACS to Enhance Language Abilities
Transcranial Alternating Current Stimulation (tACS) to Enhance Language Abilities
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Daniela Sacchetti, MS
- Phone Number: 215 573 4336
- Email: danielas@pennmedicine.upenn.edu
Study Contact Backup
- Name: Denise Harvey, PhD
- Phone Number: 215 573 4336
- Email: harveyde@pennmedicine.upenn.edu
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- University of Pennsylvania
-
Contact:
- Daniela Sacchetti, MS
- Phone Number: 215 573 4336
- Email: danielas@pennmedicine.upenn.edu
-
Contact:
- Denise Harvey, PhD
- Phone Number: 215-573-4336
- Email: harveyde@pennmedicine.upenn.edu
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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.
|
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:
|
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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.
|
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:
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
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).
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Neurobehavioral Manifestations
- Communication Disorders
- Language Disorders
- Speech Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Stroke
- Aphasia
Other Study ID Numbers
Other Study ID Numbers
- 854139
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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