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Effects of Transcranial Direct Current Stimulation (tDCS) on Language

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ClinicalTrials.gov Identifier: NCT04166513
Recruitment Status : Recruiting
First Posted : November 18, 2019
Last Update Posted : December 3, 2019
Sponsor:
Information provided by (Responsible Party):
Sara Pillay, Medical College of Wisconsin

Brief Summary:
This study will investigate the effects of mild electrical stimulation in conjunction with speech therapy for people with post-stroke aphasia to enhance language recovery.

Condition or disease Intervention/treatment Phase
Stroke Aphasia Device: Transcranial Direct Current Stimulation Device: Sham Transcranial Direct Current Stimulation Behavioral: Phonologic-Focused Speech Therapy Behavioral: Semantic-Focused Speech Therapy Not Applicable

Detailed Description:

Aphasia is a disturbance of language, primarily caused by brain injury to the left cerebral hemisphere. Aphasia treatments include speech and language therapy and pharmacologic therapy, but several studies have found that these treatments are not completely effective for patients with aphasia, leaving them with residual deficits that significantly add to the cost of stroke-related care. Additionally, the amount and frequency of speech and language therapy delivered may have a critical effect on recovery. Therefore, there is a need for new treatments or adjuncts to existing treatments, such as brain stimulation interventions, that have the potential to show greater improvements in patients with aphasia. One such new approach for non-invasive brain stimulation is transcranial direct current stimulation (tDCS).

This study will examine the effects of tDCS during speech therapy to further examine which method or methods is best for patient recovery. Patients enrolled in the study will undergo language testing that covers a broad range of language functions. Functional Magnetic Resonance Imaging (fMRI) will be completed before and after speech therapy intervention arms to investigate the neural processes affected by tDCS and speech therapy.

Study design:

Patients will be randomly assigned to one of 4 groups in a double-blind, partial crossover design. Patients will receive one of two different speech therapy treatment interventions to focus on specific processing deficits. Participants will undergo neuropsychological evaluation assessment before receiving sham or anodal-tDCS for 10 therapy sessions. Participants will then be re-tested using the behavioral assessment measure before crossing over to either receive sham or anodal-tDCS (whichever they have not already received), within the same speech therapy arm. They will complete a final behavioral assessment at the completion of the treatment.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Partial crossover design. Participants will maintain one of two speech therapy modalities throughout the study, but will crossover from active to sham stimulation (or vice versa).
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Care provider, participant, and investigator are unmasked for speech therapy modality, but all are masked for tDCS sham or active status.
Primary Purpose: Treatment
Official Title: Effects of tDCS on Language Recovery in Post-Stroke Aphasia
Actual Study Start Date : December 1, 2019
Estimated Primary Completion Date : December 31, 2029
Estimated Study Completion Date : December 31, 2029

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active tDCS with Phonologic-Focused Speech Therapy
Participants will receive phonologic-focused speech therapy with anodal-tDCS for 10 therapy sessions before.
Device: Transcranial Direct Current Stimulation
High-Definition-tDCS will be delivered via a battery-driven constant direct current stimulator (Soterix) using a 4x1 montage (1 central anodal electrode and 4 cathodal electrodes) arranged in a HD-cap. The current is turned on and increased in a ramplike fashion over approximately 30 seconds until reaching a strength of no more than 2mA, with a current density equal to 0.08mA/cm2. Stimulation will be maintained no longer than 20 minutes.
Other Names:
  • HD-tDCS
  • tDCS

Behavioral: Phonologic-Focused Speech Therapy
Participants are asked to generate or choose from a list phonologic information about a target picture.
Other Name: Phonologic Component Analysis

Sham Comparator: Sham tDCS with Phonologic-Focused Speech Therapy
Participants will receive phonologic-focused speech therapy with sham tDCS for 10 therapy sessions.
Device: Sham Transcranial Direct Current Stimulation
High-Definition-tDCS will be delivered via a battery-driven constant direct current stimulator (Soterix) using a 4x1 montage (1 central anodal electrode and 4 cathodal electrodes) arranged in a HD-cap. The current is turned on and increased in a ramplike fashion for 10 to 30 seconds and then ramped down. In this way, the participants experience the same initial sensations (mild tingling) as the tDCS group.
Other Names:
  • Sham tDCS
  • Sham HD-tDCS

Behavioral: Phonologic-Focused Speech Therapy
Participants are asked to generate or choose from a list phonologic information about a target picture.
Other Name: Phonologic Component Analysis

Active Comparator: Active tDCS with Semantic-Focused Speech Therapy
Participants will receive semantic-focused speech therapy with anodal-tDCS for 10 therapy sessions.
Device: Transcranial Direct Current Stimulation
High-Definition-tDCS will be delivered via a battery-driven constant direct current stimulator (Soterix) using a 4x1 montage (1 central anodal electrode and 4 cathodal electrodes) arranged in a HD-cap. The current is turned on and increased in a ramplike fashion over approximately 30 seconds until reaching a strength of no more than 2mA, with a current density equal to 0.08mA/cm2. Stimulation will be maintained no longer than 20 minutes.
Other Names:
  • HD-tDCS
  • tDCS

Behavioral: Semantic-Focused Speech Therapy
Participants who have difficulty retrieving an object name are given hierarchical clues or asked questions about the objects function as a way of activating the semantic network for that object, leading to eventual retrieval of the target word.
Other Name: Semantic Feature Analysis

Sham Comparator: Sham tDCS with Semantic-Focused Speech Therapy
Participants will receive semantic-focused speech therapy with sham tDCS for 10 therapy sessions.
Device: Sham Transcranial Direct Current Stimulation
High-Definition-tDCS will be delivered via a battery-driven constant direct current stimulator (Soterix) using a 4x1 montage (1 central anodal electrode and 4 cathodal electrodes) arranged in a HD-cap. The current is turned on and increased in a ramplike fashion for 10 to 30 seconds and then ramped down. In this way, the participants experience the same initial sensations (mild tingling) as the tDCS group.
Other Names:
  • Sham tDCS
  • Sham HD-tDCS

Behavioral: Semantic-Focused Speech Therapy
Participants who have difficulty retrieving an object name are given hierarchical clues or asked questions about the objects function as a way of activating the semantic network for that object, leading to eventual retrieval of the target word.
Other Name: Semantic Feature Analysis




Primary Outcome Measures :
  1. Language performance on Picture Naming and Reading Tasks [ Time Frame: Through the study completion, about 6 months ]
    Improvement on trained and untrained items used during therapy. Items will consist of words and pictures that participants will name. Percent change between pre-assessment and post-therapy time 1 and between post-therapy time 2 will be the primary behavioral outcome measure.


Secondary Outcome Measures :
  1. fMRI [ Time Frame: Through the study completion, about 6 months ]
    Participants will undergo resting-state fMRI and task-fMRI at 3 time points during the study (pre-assessment, post-therapy time 1 and post-therapy time 2. Rs-FMRI functional connectivity changes between time points will be assessed to examine how network brain connectivity changes as a result of speech therapy and tDCS intervention. Task-based fMRI will be used to create a laterality index to determine which hemisphere of the brain is more dominant for language pre-therapy, and if this laterality changes as a result of therapy. Change scores between assessment time points will be the primary outcome measure.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a language deficit from focal neurologic damage (e.g. stroke, tumor).
  • Patients must be adults and have English-language fluency.
  • Patients must be eligible to undergo MRI.

Exclusion Criteria:

  • Advanced neurodegenerative disease (i.e. Stage 3 Alzheimer's disease) or neurologic disorder (e.g. idiopathic epilepsy, Parkinson's disease, ALS)
  • Severe psychopathology (e.g. schizophrenia, bipolar disorder, acute major depressive episode)
  • No suspected or diagnosed uncorrectable hearing or vision difficulties, or developmental disabilities (i.e. intellectual disability or learning disability).
  • Contraindications to MRI such as claustrophobia, implanted electronic devices, MRI-incompatible metal in the body, extreme obesity, pregnancy, inability to lie flat, and inability to see or hear stimulus materials

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04166513


Contacts
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Contact: Samantha Drane 414-955-5891 sdrane@mcw.edu

Locations
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United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Samantha Drane, MS    414-955-5891    sdrane@mcw.edu   
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
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Principal Investigator: Sara Pillay, PhD Medical College of Wisconsin

Publications:
Boysen AE, Wertz RT. Clinician Costs in Aphasia Treatment: How Much Is a Word Worth? Clin. Aphasiology 1996;24:207-213.
Boyle M, Coelho CA. Application of semantic feature analysis as a treatment for aphasic dysnomia. Am. J. Speech Lang. Pathol. 1995;4(4):94-98
Leonard C, Rochon E, Laird L. Treating naming impairments in aphasia: Findings from a phonological components analysis treatment. Aphasiology 2008;22(9):923-947.

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Responsible Party: Sara Pillay, Assistant Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT04166513     History of Changes
Other Study ID Numbers: 33162
First Posted: November 18, 2019    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Sara Pillay, Medical College of Wisconsin:
tDCS
treatment
brain stimulation
Additional relevant MeSH terms:
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Aphasia
Nervous System Diseases
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms