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Transcranial Alternating Current Stimulation (tACS) in Aphasia

Primary Purpose

Aphasia, Stroke

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
tACS 10-Hz
tACS 40-Hz
tACS sham
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia focused on measuring language, language impairment, transcranial alternating current stimulation, tACS

Eligibility Criteria

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

Inclusion Criteria:

Healthy Controls

  • 18 years of age or older
  • Fluent in English
  • No history of neurological or psychiatric disorders

Stroke Patients

  • Diagnosed with post-stroke aphasia by referring physician/neuropsychologist
  • Consent date >=1 months after stroke onset
  • Right-handed
  • Fluent in English
  • 18 years of age or older

Exclusion Criteria:

  • Severe cognitive, auditory or visual impairments that would preclude cognitive and language testing
  • Presence of major untreated or unstable psychiatric disease
  • A chronic medical condition that is not treated or is unstable
  • The presence of cardiac stimulators or pacemakers
  • Any metal implants in the skull
  • Contraindications to MRI or tACS
  • History of seizures
  • History of dyslexia or other developmental learning disabilities

Sites / Locations

  • Medical College of WisconsinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

tACS 10 Hz low frequency

tACS 40 Hz high frequency

tACS sham

Arm Description

High-Definition-tACS will be delivered via a battery operated alternating current stimulator (Soterix) using two 3x1 center-surround montages. Targets of stimulation will be localized based on the 10-10 International EEG system with center electrodes placed at a frontal and a temporoparietal site. The current is turned on and increased in a ramplike fashion over approximately 30 seconds. Participants will undergo tACS with 10-Hz stimulation for 20-minutes with 1 milliampere (mA) peak-to-peak intensity. Stimulation will be maintained no longer than 20 minutes.

High-Definition-tACS will be delivered via a battery operated alternating current stimulator (Soterix) using two 3x1 center-surround montages. Targets of stimulation will be localized based on the 10-10 International EEG system with center electrodes placed at a frontal and a temporoparietal site. The current is turned on and increased in a ramplike fashion over approximately 30 seconds. Participants will undergo tACS with 40-Hz stimulation for 20-minutes with 1 milliampere (mA) peak-to-peak intensity. Stimulation will be maintained no longer than 20 minutes.

High-Definition-tACS will be delivered via a battery operated alternating current stimulator (Soterix) using two 3x1 center-surround montages. Targets of stimulation will be localized based on the 10-10 International EEG system with center electrodes placed at a frontal and a temporoparietal site. The current is turned on and increased in a ramplike fashion for 10 to 30 seconds and then ramped down. In this way, the participants experience the same initial sensations (mild tingling) as the active tACS groups.

Outcomes

Primary Outcome Measures

tACS frequency-dependent changes in language performance on object and action naming tasks
Improvement on noun and verb retrieval performance as determined by increases in accuracy and decreases in reaction time.
tACS frequency-dependent neurophysiological changes
Concomitant frequency-specific EEG changes in spectral power and phase synchronization are expected.

Secondary Outcome Measures

Individual differences in tACS responsiveness
tACS responsiveness depending on language impairment types, stroke lesion and language lateralization characteristics will be explored.

Full Information

First Posted
May 1, 2020
Last Updated
September 1, 2022
Sponsor
Medical College of Wisconsin
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1. Study Identification

Unique Protocol Identification Number
NCT04375722
Brief Title
Transcranial Alternating Current Stimulation (tACS) in Aphasia
Official Title
Exogenous Tuning of Neural Oscillations as a Mode of Treatment in Post-stroke Aphasia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 4, 2020 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will assess the effects of transcranial alternating current stimulation (tACS) on language recovery after stroke as well as healthy language functions.
Detailed Description
Aphasia is a debilitating disorder, typically resulting from damage to the left hemisphere, that can impair a range of communication abilities, including language production and comprehension, reading, and writing. Approximately 180,000 new cases of aphasia are identified per year, and approximately 1 million or 1 in 250 are living with aphasia in the United States (NIH-NIDCD, 2015). Treatments are limited and provide modest benefits at best. The current emphasis in aphasia rehabilitation is to formulate intensive speech and language therapies and augment therapeutic benefits by providing brain stimulation concurrent with therapies. Transcranial direct current stimulation (tDCS) is one of the most widely used such technique. While tDCS has had relative success in chronic aphasia (>6 months after stroke), it has not been efficacious during subacute stages (<3 months after stroke). But enhancing language recovery early after stroke is desirable because of its potential impact on long-term language outcomes and quality-of-life. The current study will investigate the efficacy of high-definition tACS (HD-tACS) to help restore neural oscillatory activity in aphasia. TACS differs from tDCS in that sinusoidal, alternating currents are delivered rather than constant currents. TACS can manipulate the ongoing oscillatory neuronal activity and potentially increase functional synchronization (or connectivity) between targeted areas. This feature of tACS is quite attractive, given the new body of evidence suggesting that language impairments stem from diminished functional connectivity and disruptions in the language network due to stroke. The selection of tACS frequencies in this study is guided by our preliminary work examining pathological neural oscillations found near stroke-lesioned areas (or perilesional) in aphasia. By exogenously tuning the perilesional oscillations with tACS, the investigators hope to up-regulate communication across these areas and other connected areas to improve language outcome. If successful, tACS will be a powerful and novel treatment approach with reverberating positive impact on long-term recovery. The study will employ HD-tACS in a within-subject and sham-controlled design, using two frequencies (alpha/10 Hz and low-gamma/40 Hz) combined with language tasks and electroencephalography (EEG) to evaluate subsequent behavioral and neurophysiological changes. Investigators plan to recruit 50 participants: 25 stroke survivors with aphasia at lease 1 month after stroke, and 25 healthy controls. Participants will complete language testing that covers a broad range of language functions, medical history, and MRI. Eligible participants will undergo active tACS at 10 Hz or 40 Hz, or sham-tACS. All participants will receive all three stimulation types during separate visits. The tACS administrator and participants will be blinded to the stimulation type. The order of stimulation type will be counterbalanced across participants. Washout period between visits will be at least 48 hours to minimize potential carryover effects. EEG will be acquired before and after tACS during periods of rest (resting-state) and during language tasks. Participants will complete a questionnaire at the end of stimulation visits to assess potential side effects of tACS. Total time enrolled in the study is expected to be 2-3 weeks, which may be longer depending on participant's availability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia, Stroke
Keywords
language, language impairment, transcranial alternating current stimulation, tACS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
In the within-subject design healthy participants and stroke survivors will receive tACS stimulation at 10 Hz, 40 Hz, and sham settings in a randomized order with >48 hours washout period in between stimulation sessions.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Participant, care provider, investigator and outcomes assessor are all blinded. One study team member will be designated as unblinded.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tACS 10 Hz low frequency
Arm Type
Experimental
Arm Description
High-Definition-tACS will be delivered via a battery operated alternating current stimulator (Soterix) using two 3x1 center-surround montages. Targets of stimulation will be localized based on the 10-10 International EEG system with center electrodes placed at a frontal and a temporoparietal site. The current is turned on and increased in a ramplike fashion over approximately 30 seconds. Participants will undergo tACS with 10-Hz stimulation for 20-minutes with 1 milliampere (mA) peak-to-peak intensity. Stimulation will be maintained no longer than 20 minutes.
Arm Title
tACS 40 Hz high frequency
Arm Type
Experimental
Arm Description
High-Definition-tACS will be delivered via a battery operated alternating current stimulator (Soterix) using two 3x1 center-surround montages. Targets of stimulation will be localized based on the 10-10 International EEG system with center electrodes placed at a frontal and a temporoparietal site. The current is turned on and increased in a ramplike fashion over approximately 30 seconds. Participants will undergo tACS with 40-Hz stimulation for 20-minutes with 1 milliampere (mA) peak-to-peak intensity. Stimulation will be maintained no longer than 20 minutes.
Arm Title
tACS sham
Arm Type
Sham Comparator
Arm Description
High-Definition-tACS will be delivered via a battery operated alternating current stimulator (Soterix) using two 3x1 center-surround montages. Targets of stimulation will be localized based on the 10-10 International EEG system with center electrodes placed at a frontal and a temporoparietal site. The current is turned on and increased in a ramplike fashion for 10 to 30 seconds and then ramped down. In this way, the participants experience the same initial sensations (mild tingling) as the active tACS groups.
Intervention Type
Device
Intervention Name(s)
tACS 10-Hz
Intervention Description
Low frequency alternating current will be applied.
Intervention Type
Device
Intervention Name(s)
tACS 40-Hz
Intervention Description
High frequency alternating current will be applied.
Intervention Type
Device
Intervention Name(s)
tACS sham
Intervention Description
Sham stimulation setting will be applied.
Primary Outcome Measure Information:
Title
tACS frequency-dependent changes in language performance on object and action naming tasks
Description
Improvement on noun and verb retrieval performance as determined by increases in accuracy and decreases in reaction time.
Time Frame
Immediate changes monitored after 20 minutes of tACS of each type
Title
tACS frequency-dependent neurophysiological changes
Description
Concomitant frequency-specific EEG changes in spectral power and phase synchronization are expected.
Time Frame
Immediate changes monitored after 20 minutes of tACS of each type
Secondary Outcome Measure Information:
Title
Individual differences in tACS responsiveness
Description
tACS responsiveness depending on language impairment types, stroke lesion and language lateralization characteristics will be explored.
Time Frame
Based on immediate changes monitored after 20 minutes of tACS of each type

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: Healthy Controls 18 years of age or older Fluent in English No history of neurological or psychiatric disorders Stroke Patients Diagnosed with post-stroke aphasia by referring physician/neuropsychologist Consent date >=1 months after stroke onset Right-handed Fluent in English 18 years of age or older Exclusion Criteria: Severe cognitive, auditory or visual impairments that would preclude cognitive and language testing Presence of major untreated or unstable psychiatric disease A chronic medical condition that is not treated or is unstable The presence of cardiac stimulators or pacemakers Any metal implants in the skull Contraindications to MRI or tACS History of seizures History of dyslexia or other developmental learning disabilities
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samantha Drane, MS
Phone
414-955-5891
Ext
4149555894
Email
sdrane@mcw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Priyanka Shah-Basak, PhD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samantha Drane, MS
Phone
414-955-5891
Email
sdrane@mcw.edu

12. IPD Sharing Statement

Plan to Share IPD
No
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Transcranial Alternating Current Stimulation (tACS) in Aphasia

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