Targeted TDCS to Enhance Speech-Language Treatment Outcome in Persons With Chronic Post-Stroke Aphasia.

NCT ID: NCT04432883

Last Updated: 2025-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-18

Study Completion Date

2027-04-30

Brief Summary

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62 patients who are one year post stroke and have Aphasia as a result of that stroke will be recruited. Participants will have 4 assessment sessions and 15 treatment sessions. The TDCS will be to right Inferior Frontal Gyrus (IFG) (25 active, 25 sham) for 15 days. A combined semantic feature analysis/phonological components analysis treatment will be paired with the stimulation. Two assessment sessions will be pretreatment, 1 session immediately post-treatment, and 1 session at 3 months follow-up.

Detailed Description

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Our long-term goal is to develop safe and effective treatments for the communication problems of Aphasia due to stroke that restore patients to higher levels of functioning, decrease disability, and promote higher quality of life. While language therapy for aphasia is effective, improvements are typically slow, and gains may be small. Noninvasive brain stimulation has been suggested as a method to enhance outcomes from language therapy. This study will examine whether outcomes for language therapy with brain stimulation are different from outcomes for language therapy without brain stimulation in people with aphasia. Our central hypotheses are (1) targeted right hemisphere HDtDCS (RH-HD-tDCS) administered in combination with language treatment will result in greater changes in naming accuracy than language treatment with the sham RH-HD-tDCS (2) RH-HD-tDCS plus language treatment will result in greater increases in communication within the affected hemisphere compared to language treatment plus sham RH-HD-tDCS (3) RH-HD-tDCS plus language treatment will result in greater increases in perilesional areas working together immediately post-treatment compared to language treatment plus sham RH-HD-tDCS

Conditions

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Stroke Aphasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Study Groups

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Experimental: Active cathodal tDCS + Speech-language training

In this arm, 31 patients with stroke induced Aphasia will undergo 15 sessions of active tDCS (x 30 minutes of stimulation) combined with 1 hour simultaneous speech-language training on consecutive weekdays.

Group Type ACTIVE_COMPARATOR

Active Comparator: Experimental: Active cathodal tDCS + language training

Intervention Type DEVICE

Cathodal tDCS raises neuronal membrane potentials, leading to decreased probability of depolarization from incoming stimuli.

Speech and Language training involves a combined semantic feature analysis and phonological components analysis treatment.

Comparator: Placebo cathodal tDCS + Speech-language training

In this arm, 31 patients with stroke induced Aphasia will undergo 15 sessions of sham tDCS (x 30 minutes sham) combined with 1 hour simultaneous speech-language training on consecutive weekdays..

Group Type SHAM_COMPARATOR

Sham Comparator: Placebo cathodal tDCS + Speech and language

Intervention Type BEHAVIORAL

Speech and Language training involves a combined semantic feature analysis and phonological components analysis treatment. .

Interventions

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Active Comparator: Experimental: Active cathodal tDCS + language training

Cathodal tDCS raises neuronal membrane potentials, leading to decreased probability of depolarization from incoming stimuli.

Speech and Language training involves a combined semantic feature analysis and phonological components analysis treatment.

Intervention Type DEVICE

Sham Comparator: Placebo cathodal tDCS + Speech and language

Speech and Language training involves a combined semantic feature analysis and phonological components analysis treatment. .

Intervention Type BEHAVIORAL

Other Intervention Names

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Behavioral: Speech and Language Training

Eligibility Criteria

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Inclusion Criteria

1. aged 25-85
2. must be greater than 6 months post-stroke
3. must have a diagnosis of aphasia based on impaired performance on the Western Aphasia Battery-Revised, Boston Naming Test, or during discourse production
4. must be left-hemisphere dominant as demonstrated by aphasia onset subsequent to left hemisphere damage
5. must be stimulable for naming

Exclusion Criteria

1. comorbid neurological disease.
2. damage to the anterior right hemisphere.
3. significant mood disorder.
4. substance/alcohol dependence or abuse within the past year
5. presence of any implanted electrical device or contraindications to tDCS or MRI
6. recent medical instability (within 4 weeks)
7. pregnancy
Minimum Eligible Age

25 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role collaborator

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role collaborator

University of New Mexico

OTHER

Sponsor Role lead

Responsible Party

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Jessica Richardson

Assistant Professor: SOM Neurosurgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jessica Richardson, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico

Locations

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University of New Mexico Center for Brain Recovery and Repair

Albuquerque, New Mexico, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jessica Richardson, Ph.D.

Role: CONTACT

505 277-1765

Honey Hubbard

Role: CONTACT

505-433-7766

Facility Contacts

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Darbi Gill

Role: primary

505-925-4043

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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1P20GM109089-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01DC018282

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UNM HRRC #16-091

Identifier Type: -

Identifier Source: org_study_id

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