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tACS to Enhance Language Abilities

Primary Purpose

Stroke, Aphasia, Acquired, Aphasia

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active transcranial alternating current stimulation (tACS)
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring non-invasive brain stimulation, transcranial alternating current stimulation (tACS), EEG

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

real-tACS

sham-tACS

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
September 28, 2023
Last Updated
October 17, 2023
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT06092814
Brief Title
tACS to Enhance Language Abilities
Official Title
Transcranial Alternating Current Stimulation (tACS) to Enhance Language Abilities
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 6, 2023 (Anticipated)
Primary Completion Date
June 30, 2028 (Anticipated)
Study Completion Date
June 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Aphasia, Acquired, Aphasia
Keywords
non-invasive brain stimulation, transcranial alternating current stimulation (tACS), EEG

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
The proposed study is a within-subject, double-blind & sham-controlled
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
real-tACS
Arm Type
Active Comparator
Arm Description
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.
Arm Title
sham-tACS
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Active transcranial alternating current stimulation (tACS)
Other Intervention Name(s)
Sham transcranial alternating current stimulation [(ACS)
Intervention Description
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 Measure Information:
Title
Performance on the Blocked-Cyclic Naming (BCN) Task
Description
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).
Time Frame
5-10 minutes after a single session of active (alpha tACS) and sham (fake tACS).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniela Sacchetti, MS
Phone
215 573 4336
Email
danielas@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Denise Harvey, PhD
Phone
215 573 4336
Email
harveyde@pennmedicine.upenn.edu
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denise Harvey, PhD
Phone
215-573-4336
Email
harveyde@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Daniela Sacchetti, MS
Phone
215 573 4336
Email
danielas@pennmedicine.upenn.edu

12. IPD Sharing Statement

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tACS to Enhance Language Abilities

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