Transcranial Direct Current Stimulation and Aphasia Language Therapy

NCT01486654 | Completed Phase 1

• 2 other identifiers: 1-kaye1R21DC009876-01A1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effectiveness of small amounts of electrical current, applied without surgery to the brain, in combination with speech-language treatment, on the language outcome of study subjects with nonfluent aphasia (i.e. difficulty with the comprehension and expression of spoken and written language) following a stroke.

Conditions

Nonfluent Aphasia; Stroke

Keywords

Cortical stimulation; Ischemic Stroke; Aphasia; Speech and Language Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Aphasia Quotient (AQ) on the Western Aphasia Battery

  Change from Baseline in Western Aphasia Battery at 6 weeks

Secondary Outcomes (7)

• Functional communication skills

  Change from Baseline in functional communication skills at 6 weeks

• Participation in everyday activities

  Change from Baseline in participation in everyday activities at 6 weeks

• Western Aphasia Battery - Reading and Writing scores

  Change from Baseline in Western Aphasia Battery Reading and Writing scores at 6 weeks

• Western Aphasia Battery Aphasia Quotient (Maintenance)

  Change in Western Aphasia Battery AQ from 6 weeks to 12 weeks

• Western Aphasia Battery Reading and Writing Scores (Maintenance)

  Change in WAB Reading and Writing Skills from 6 weeks to 12 weeks

Study Arms (3)

Anodal stimulation

ACTIVE COMPARATOR

Device: Transcranial Direct Current Stimulation - Anodal stimulation

Cathodal stimulation

ACTIVE COMPARATOR

Device: Transcranial Direct Current Stimulation - Cathodal stimulation

Sham stimulation

PLACEBO COMPARATOR

Device: Transcranial Direct Current Stimulation - Sham stimulation

Interventions

Transcranial Direct Current Stimulation - Cathodal stimulation DEVICE

Cathodal transcranial direct stimulation (tDCS) to the left hemisphere, 1.0 mA for 13 minutes, is received five days a week, for six weeks, during the initial 13 minutes of 90 minutes of speech-language treatment.

Also known as: Cortical stimulation, Transcranial direct current stimulation

Cathodal stimulation

Transcranial Direct Current Stimulation - Anodal stimulation DEVICE

Anodal transcranial direct stimulation (tDCS) to the left hemisphere, 1.0 mA for 13 minutes, is received five days a week, for six weeks, during the initial 13 minutes of 90 minutes of speech-language treatment.

Also known as: Cortical stimulation, Transcranial direct current stimulation

Anodal stimulation

Transcranial Direct Current Stimulation - Sham stimulation DEVICE

Sham stimulation provided together with 90 minutes of speech language therapy, 5 days a week, for 6 weeks.

Also known as: No stimulation

Sham stimulation

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A single unilateral left-hemisphere infarct that is confirmed by CT scan or MRI
• Nonfluent aphasia, with a mean length of utterance of 0-4 words and an Aphasia Quotient score on the Western Aphasia Battery of 25-70
• Age 21 or older
• At least 6 months post-stroke
• Premorbidly right-handed, as determined by the Edinburgh Handedness Inventory
• Premorbidly literate in English
• Completed at least an eighth grade education
• Visual acuity no worse than 20/100 corrected in the better eye
• Auditory acuity, aided in the better ear, no worse than 30 dB HL on a pure tone hearing screening (conducted at 500, 1000, 2000, and 4000 Hz.)

You may not qualify if:

• Any other neurological condition (other than cerebral vascular disease) that could potentially affect cognition or speech, such as Parkinson's Disease, Alzheimer's Dementia, traumatic brain injury
• Any significant psychiatric history prior to the stroke, such as severe major depression or psychotic disorder requiring hospitalization; subjects with mood disorders who are currently stable on treatment will be considered
• Active substance abuse
• Seizure disorder that precludes safe participation in this trial
• Absence of left hemisphere activation during two of the three fMRI tasks
• Presence of lesions that encompass premotor cortex from the Sylvian fissure to a point high on the convexity

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Center for Aphasia Research & Treatment, Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Aphasia, Broca; Stroke; Ischemic Stroke; Aphasia; Speech

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Verbal Behavior; Communication; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Leora R Cherney, PhD

  Rehabilitation Institute of Chicago, Chicago, IL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 2, 2011
• First Posted: December 6, 2011
• Study Start: March 1, 2010
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 15, 2017

Record last verified: 2017-05

Locations

US (1)