Improving Aphasia Using Electrical Brain Stimulation

Not Applicable

Active, not recruiting

• Conditions: Stroke; Aphasia
• Interventions: Device: Sham transcranial direct current stimulation (tDCS); Device: Active transcranial direct current stimulation (tDCS); Behavioral: Language Specific Attention Treatment

• Registration Number: NCT04963803
• Lead Sponsor: Syracuse University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-21
• Study Start: 2021-07-12
• Study First Submitted QC: 2021-07-14
• Study First Posted: 2021-07-15
• Primary Completion: 2024-11-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-20
• Last Update Posted: 2024-12-27
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

1. 18 years or older.
2. No diagnosis of neurological disorder (other than stroke).
3. No diagnosis of psychiatric disorder.
4. No seizure within the past 6 months.
5. Not pregnant.
6. In chronic phase of recovery, defined as at least 6 months post-stroke.
7. Not undergoing speech and language therapy targeting auditory comprehension or attention for the duration of the study.
8. No metal implants in the head.
9. No unhealed skull fractures.
10. Onset of aphasia related to left hemisphere stroke.
11. Damaged brain tissue from stroke does not overlap with left hemisphere dorsolateral prefrontal cortex.
12. Mild to moderate aphasia.
13. Cognitive ability minimally within functional limits.
14. Able to pass vision and hearing screening (with use of corrective aids if needed; eyeglasses, hearing aids).
15. Willing to allow audio-recording of study sessions.

Exclusion Criteria

1. Younger than 18 years old.
2. Diagnosis or history of neurological disorder other than stroke.
3. Diagnosis or history of psychiatric disorder.
4. History of seizures within the past 6 months.
5. Pregnant.
6. <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)
7. Currently undergoing speech and language therapy targeting auditory comprehension or attention.
8. Metal implants in the head.
9. Currently has a skull fracture.
10. Onset of aphasia related to etiology other than left hemisphere stroke.
11. Damaged brain tissue includes left hemisphere dorsolateral prefrontal cortex.
12. No aphasia or severe aphasia.
13. Cognitive ability below functional limits.
14. Unable to pass vision and/or hearing screening with use of corrective aids.
15. Unwilling to allow audio-recording of study sessions.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active transcranial direct current stimulation (tDCS) paired with speech-language therapy	Language Specific Attention Treatment	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) paired with speech-language therapy	Sham transcranial direct current stimulation (tDCS)	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.
Active transcranial direct current stimulation (tDCS) paired with speech-language therapy	Active transcranial direct current stimulation (tDCS)	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) paired with speech-language therapy	Language Specific Attention Treatment	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline in auditory comprehension on Language Specific Attention Treatment Probe Task	baseline; following completion of 10 treatment sessions, 5-6 weeks; 10-11 weeks	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

Name	Time	Method
Change from baseline on Attention Network Test	baseline; following completion of 10 treatment sessions, 5-6 weeks; 10-11 weeks	Tests different types of attention (alerting, orienting, executive)
Change from baseline on The Revised Token Test	baseline; following completion of 10 treatment sessions, 5-6 weeks; 10-11 weeks	Assesses auditory comprehension in persons with aphasia by asking participants to point to tokens given a verbally presented instruction.
Change from baseline on Continuous Performance Test	baseline; following completion of 10 treatment sessions, 5-6 weeks; 10-11 weeks	Tests participants' ability to sustain attention on a task
Change from baseline on The Scenario Test	baseline; following completion of 10 treatment sessions, 5-6 weeks; 10-11 weeks	Assesses functional communication and discourse using pictures and scenario prompts.
Change from baseline on an Auditory Digit Span Task	baseline; following completion of 10 treatment sessions, 5-6 weeks; 10-11 weeks	Assesses auditory working memory by asking participants to recall strings of numbers.

Trial Locations

Locations (1)

Syracuse University; 🇺🇸 Syracuse, New York, United States