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Transcranial Direct Current Stimulation (tDCS) for Aphasia

N/A

Recruiting

Research Sponsored by Syracuse University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No unhealed skull fractures

No seizure within the past 6 months

Must not have

Damaged brain tissue includes left hemisphere dorsolateral prefrontal cortex

Younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

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

Summary

This trial will investigate whether active electrical brain stimulation can help people with aphasia recover their language ability faster than those who receive sham stimulation.

Who is the study for?

This trial is for adults over 18 with mild to moderate aphasia from a left hemisphere stroke, at least 6 months post-stroke. Participants must not be undergoing specific speech therapy during the study, have no metal head implants, seizures in the past 6 months, severe psychiatric disorders or unhealed skull fractures. They should be able to hear and see well enough (with aids if needed) for testing.

What is being tested?

The study tests if brain stimulation paired with language therapy helps people with aphasia recover better than just language therapy alone. Some will get real electrical brain stimulation (active tDCS), while others get fake stimulation (sham tDCS), along with their language treatment.

What are the potential side effects?

Transcranial direct current stimulation may cause discomfort at the electrode site on the scalp, itching, tingling, headache or fatigue during application. Serious side effects are rare but can include mania or hypomania in vulnerable individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I do not have any unhealed skull fractures.

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I haven't had a seizure in the last 6 months.

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I have not been diagnosed with a psychiatric disorder.

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I am 18 years old or older.

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I developed speech difficulties after a stroke in the left side of my brain.

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I have some difficulty speaking or understanding language.

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I have not been diagnosed with a neurological disorder, except for a stroke.

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My thinking and memory skills are good enough for daily activities.

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I am not receiving speech therapy for understanding or focus during the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My brain injury affects the front part of my left brain.

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I am under 18 years old.

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My speech difficulties are not due to a stroke in the left side of my brain.

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I have metal implants in my head.

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I currently have a broken skull.

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I have difficulty with thinking or memory tasks.

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I have not had a seizure in the last 6 months.

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I have a neurological condition that is not a stroke.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; following completion of 10 treatment sessions, 5-6 weeks; 10-11 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Change from baseline on Attention Network Test

Change from baseline on Continuous Performance Test

Change from baseline on The Revised Token Test

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active transcranial direct current stimulation (tDCS) paired with speech-language therapyExperimental Treatment2 Interventions

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.

Group II: Sham transcranial direct current stimulation (tDCS) paired with speech-language therapyPlacebo Group2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Active transcranial direct current stimulation (tDCS)

2017

N/A

~40

0 / 17Eligibility criteria met