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Improving Aphasia Using Electrical Brain Stimulation

Primary Purpose

Stroke, Aphasia

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Active transcranial direct current stimulation (tDCS)

Sham transcranial direct current stimulation (tDCS)

Language Specific Attention Treatment

About this trial

This is an interventional treatment trial for Stroke focused on measuring tDCS, attention, language, speech-language therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18 years or older.
No diagnosis of neurological disorder (other than stroke).
No diagnosis of psychiatric disorder.
No seizure within the past 6 months.
Not pregnant.
In chronic phase of recovery, defined as at least 6 months post-stroke.
Not undergoing speech and language therapy targeting auditory comprehension or attention for the duration of the study.
No metal implants in the head.
No unhealed skull fractures.
Onset of aphasia related to left hemisphere stroke.
Damaged brain tissue from stroke does not overlap with left hemisphere dorsolateral prefrontal cortex.
Mild to moderate aphasia.
Cognitive ability minimally within functional limits.
Able to pass vision and hearing screening (with use of corrective aids if needed; eyeglasses, hearing aids).
Willing to allow audio-recording of study sessions.

Exclusion Criteria:

Younger than 18 years old.
Diagnosis or history of neurological disorder other than stroke.
Diagnosis or history of psychiatric disorder.
History of seizures within the past 6 months.
Pregnant.
<6 months post-stroke (however, if this is only exclusionary criterion met, participant can be re-evaluated at the 6-month mark if still interested in the study)
Currently undergoing speech and language therapy targeting auditory comprehension or attention.
Metal implants in the head.
Currently has a skull fracture.
Onset of aphasia related to etiology other than left hemisphere stroke.
Damaged brain tissue includes left hemisphere dorsolateral prefrontal cortex.
No aphasia or severe aphasia.
Cognitive ability below functional limits.
Unable to pass vision and/or hearing screening with use of corrective aids.
Unwilling to allow audio-recording of study sessions.

Sites / Locations

Syracuse UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active transcranial direct current stimulation (tDCS) paired with speech-language therapy

Sham transcranial direct current stimulation (tDCS) paired with speech-language therapy

Arm Description

Active transcranial direct current stimulation (tDCS) will be delivered using a Soterix mini-CT device. Participants receiving this treatment will be administered 2 milliamperes (mA) of current for 20 minutes/session with the anode electrode placed over F3 and the cathode electrode placed over Fp2 (according to the 1020 system). The tDCS will be paired with 60 minutes of speech-language therapy focusing simultaneously improving auditory comprehension and behavioral attention. All study participants will receive 10 sessions of this combination treatment with no more than one session per day 2-3 times per week.

Sham transcranial direct current stimulation (tDCS) will be delivered using a Soterix mini-CT device. Participants receiving this treatment will be administered 2 milliamperes (mA) of current for 1 minute to simulate the experience of tDCS, after which the current will be ramped down to zero for the remaining 19 minutes of the session with the anode electrode placed over F3 and the cathode electrode placed over Fp2 (according to the 1020 system). The tDCS will be paired with 60 minutes of speech-language therapy focusing simultaneously improving auditory comprehension and behavioral attention. All study participants will receive 10 sessions of this combination treatment with no more than one session per day 2-3 times per week.

Outcomes

Primary Outcome Measures

Change from baseline in auditory comprehension on Language Specific Attention Treatment Probe Task

Tests participants' ability to comprehend auditory information at the sentence level. This outcome measure consists of untrained sentences from the speech and language therapy protocol.

Secondary Outcome Measures

Change from baseline on Continuous Performance Test

Tests participants' ability to sustain attention on a task

Change from baseline on Attention Network Test

Tests different types of attention (alerting, orienting, executive)

Change from baseline on The Scenario Test

Assesses functional communication and discourse using pictures and scenario prompts.

Change from baseline on an Auditory Digit Span Task

Assesses auditory working memory by asking participants to recall strings of numbers.

Change from baseline on The Revised Token Test

Assesses auditory comprehension in persons with aphasia by asking participants to point to tokens given a verbally presented instruction.

Full Information

NCT ID

NCT04963803

First Posted

June 21, 2021

Last Updated

August 15, 2022

Sponsor

Syracuse University

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

1. Study Identification

Unique Protocol Identification Number

NCT04963803

Brief Title

Improving Aphasia Using Electrical Brain Stimulation

Official Title

Improving Aphasia Outcomes Through tDCS-Mediated Attention Management

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 12, 2021 (Actual)

Primary Completion Date

August 31, 2023 (Anticipated)

Study Completion Date

August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Syracuse University

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Language and communication are essential for almost every aspect of human life, but for people who have aphasia, a language processing disorder that can occur after stroke or brain injury, even simple conversations can become a formidable challenge. Speech and language therapy can help people recover their language ability, but often requires months or even years of therapy before a person is able to overcome these challenges. This research will investigate non-invasive brain stimulation as a way to enhance the effects of speech and language therapy, which may ultimately lead to better and faster recovery from stroke and aphasia. The investigators hypothesize that participants with aphasia who receive speech and language therapy paired with active electrical brain stimulation will improve significantly more on a language comprehension task than those who receive speech and language therapy paired with sham stimulation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Aphasia

Keywords

tDCS, attention, language, speech-language therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active transcranial direct current stimulation (tDCS) paired with speech-language therapy

Arm Type

Experimental

Arm Description

Arm Title

Sham transcranial direct current stimulation (tDCS) paired with speech-language therapy

Arm Type

Sham Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Active transcranial direct current stimulation (tDCS)

Intervention Description

Active transcranial direct current stimulation will be delivered using a Soterix mini-CT device. Participants receiving this treatment will be administered 2 milliamperes (mA) of current for 20 minutes/session for 10 sessions.

Intervention Type

Device

Intervention Name(s)

Sham transcranial direct current stimulation (tDCS)

Intervention Description

Sham transcranial direct current stimulation will be delivered using a Soterix mini-CT device. Participants receiving this treatment will be administered 2 milliamperes (mA) of current for 1 minute to simulate the experience of tDCS, after which the current will be ramped down to zero for the remaining 19 minutes of the session. Participants in this arm will receive sham stimulation for 10 sessions.

Intervention Type

Behavioral

Intervention Name(s)

Language Specific Attention Treatment

Intervention Description

This is a specific type of speech-language therapy that focuses on simultaneously improving auditory comprehension and behavioral attention. All study participants will receive 10 sessions of this treatment.

Primary Outcome Measure Information:

Title

Change from baseline in auditory comprehension on Language Specific Attention Treatment Probe Task

Description

Tests participants' ability to comprehend auditory information at the sentence level. This outcome measure consists of untrained sentences from the speech and language therapy protocol.

Time Frame

baseline; following completion of 10 treatment sessions, 5-6 weeks; 10-11 weeks

Secondary Outcome Measure Information:

Title

Change from baseline on Continuous Performance Test

Description

Tests participants' ability to sustain attention on a task

Time Frame

baseline; following completion of 10 treatment sessions, 5-6 weeks; 10-11 weeks

Title

Change from baseline on Attention Network Test

Description

Tests different types of attention (alerting, orienting, executive)

Time Frame

baseline; following completion of 10 treatment sessions, 5-6 weeks; 10-11 weeks

Title

Change from baseline on The Scenario Test

Description

Assesses functional communication and discourse using pictures and scenario prompts.

Time Frame

baseline; following completion of 10 treatment sessions, 5-6 weeks; 10-11 weeks

Title

Change from baseline on an Auditory Digit Span Task

Description

Assesses auditory working memory by asking participants to recall strings of numbers.

Time Frame

baseline; following completion of 10 treatment sessions, 5-6 weeks; 10-11 weeks

Title

Change from baseline on The Revised Token Test

Description

Assesses auditory comprehension in persons with aphasia by asking participants to point to tokens given a verbally presented instruction.

Time Frame

baseline; following completion of 10 treatment sessions, 5-6 weeks; 10-11 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 years or older. No diagnosis of neurological disorder (other than stroke). No diagnosis of psychiatric disorder. No seizure within the past 6 months. Not pregnant. In chronic phase of recovery, defined as at least 6 months post-stroke. Not undergoing speech and language therapy targeting auditory comprehension or attention for the duration of the study. No metal implants in the head. No unhealed skull fractures. Onset of aphasia related to left hemisphere stroke. Damaged brain tissue from stroke does not overlap with left hemisphere dorsolateral prefrontal cortex. Mild to moderate aphasia. Cognitive ability minimally within functional limits. Able to pass vision and hearing screening (with use of corrective aids if needed; eyeglasses, hearing aids). Willing to allow audio-recording of study sessions. Exclusion Criteria: Younger than 18 years old. Diagnosis or history of neurological disorder other than stroke. Diagnosis or history of psychiatric disorder. History of seizures within the past 6 months. Pregnant. <6 months post-stroke (however, if this is only exclusionary criterion met, participant can be re-evaluated at the 6-month mark if still interested in the study) Currently undergoing speech and language therapy targeting auditory comprehension or attention. Metal implants in the head. Currently has a skull fracture. Onset of aphasia related to etiology other than left hemisphere stroke. Damaged brain tissue includes left hemisphere dorsolateral prefrontal cortex. No aphasia or severe aphasia. Cognitive ability below functional limits. Unable to pass vision and/or hearing screening with use of corrective aids. Unwilling to allow audio-recording of study sessions.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ellyn A Riley, PHD

Phone

315-443-9621

earil100@syr.edu

Facility Information:

Facility Name

Syracuse University

City

Syracuse

State/Province

New York

ZIP/Postal Code

13244

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ellyn A Riley, PhD

Phone

315-443-9621

earil100@syr.edu

First Name & Middle Initial & Last Name & Degree

Ellyn A Riley, PhD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

The final dataset will include self-reported demographic data (e.g., age, race, gender), medical information related to participant's stroke (e.g., date of onset, lesion location), and behavioral data obtained from cognitive and language tasks administered in the Syracuse University Aphasia Lab as part of the study. The final computerized dataset will be stripped of all personal identifiers. The investigators will make the data and associated documentation available to users only via a signed data-sharing agreement that stipulates a commitment to: (1) only use the data for research purposes and not to identify any individual participants, (2) securely storing the data via password-protected databases and secure servers, and (3) destroying or returning the data after analyses are completed. Data sharing will be available upon publication of the main study findings.

IPD Sharing Time Frame

Starting 1 year after publication.

IPD Sharing Access Criteria

The investigators will make the data and associated documentation available to users only via a signed data-sharing agreement that stipulates a commitment to: (1) only use the data for research purposes and not to identify any individual participants, (2) securely storing the data via password-protected databases and secure servers, and (3) destroying or returning the data after analyses are completed.

Citations:

PubMed Identifier

28201833

Citation

Peach RK, Nathan MR, Beck KM. Language-Specific Attention Treatment for Aphasia: Description and Preliminary Findings. Semin Speech Lang. 2017 Feb;38(1):5-16. doi: 10.1055/s-0036-1597260. Epub 2017 Feb 15.

Results Reference

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PubMed Identifier

31348732

Citation

Peach RK, Beck KM, Gorman M, Fisher C. Clinical Outcomes Following Language-Specific Attention Treatment Versus Direct Attention Training for Aphasia: A Comparative Effectiveness Study. J Speech Lang Hear Res. 2019 Aug 15;62(8):2785-2811. doi: 10.1044/2019_JSLHR-L-18-0504. Epub 2019 Jul 25.

Results Reference

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PubMed Identifier

30128538

Citation

Fridriksson J, Rorden C, Elm J, Sen S, George MS, Bonilha L. Transcranial Direct Current Stimulation vs Sham Stimulation to Treat Aphasia After Stroke: A Randomized Clinical Trial. JAMA Neurol. 2018 Dec 1;75(12):1470-1476. doi: 10.1001/jamaneurol.2018.2287.

Results Reference

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PubMed Identifier

31300247

Citation

Riley EA, Wu Y. Artificial grammar learning with transcranial direct current stimulation (tDCS): A pilot study. Brain Stimul. 2019 Sep-Oct;12(5):1307-1308. doi: 10.1016/j.brs.2019.07.002. Epub 2019 Jul 2. No abstract available.

Results Reference

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PubMed Identifier

22524787

Citation

Petersen SE, Posner MI. The attention system of the human brain: 20 years after. Annu Rev Neurosci. 2012;35:73-89. doi: 10.1146/annurev-neuro-062111-150525. Epub 2012 Apr 12.

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PubMed Identifier

26652115

Citation

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PubMed Identifier

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Citation

Floel A, Rosser N, Michka O, Knecht S, Breitenstein C. Noninvasive brain stimulation improves language learning. J Cogn Neurosci. 2008 Aug;20(8):1415-22. doi: 10.1162/jocn.2008.20098.

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Citation

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Improving Aphasia Using Electrical Brain Stimulation

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