Improving Aphasia Using Electrical Brain Stimulation

Study Overview
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Brief Summary
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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.

Official Title
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Improving Aphasia Outcomes Through tDCS-Mediated Attention Management

Conditions
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Stroke, Aphasia

Intervention / Treatment
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* Device: Active transcranial direct current stimulation (tDCS)
* Device: Sham transcranial direct current stimulation (tDCS)
* Behavioral: Language Specific Attention Treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active transcranial direct current stimulation (tDCS) paired with speech-language therapy<br>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. | Device: Active transcranial direct current stimulation (tDCS)<br>* 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.<br>Behavioral: Language Specific Attention Treatment<br>* 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.<br>|
| Sham Comparator: Sham transcranial direct current stimulation (tDCS) paired with speech-language therapy<br>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. | Device: Sham transcranial direct current stimulation (tDCS)<br>* 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.<br>Behavioral: Language Specific Attention Treatment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline; following completion of 10 treatment sessions, 5-6 weeks; 10-11 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline on Continuous Performance Test | Tests participants' ability to sustain attention on a task | baseline; following completion of 10 treatment sessions, 5-6 weeks; 10-11 weeks | 
| Change from baseline on Attention Network Test | Tests different types of attention (alerting, orienting, executive) | baseline; following completion of 10 treatment sessions, 5-6 weeks; 10-11 weeks | 
| Change from baseline on The Scenario Test | Assesses functional communication and discourse using pictures and scenario prompts. | baseline; following completion of 10 treatment sessions, 5-6 weeks; 10-11 weeks | 
| Change from baseline on an Auditory Digit Span Task | Assesses auditory working memory by asking participants to recall strings of numbers. | baseline; following completion of 10 treatment sessions, 5-6 weeks; 10-11 weeks | 
| 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. | baseline; following completion of 10 treatment sessions, 5-6 weeks; 10-11 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tDCS, attention, language, speech-language therapy