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Trial record 19 of 45 for:    NOT MRI NOT Imaging NOT intensive NOT auditory NOT thermal NOT mirror NOT TENS NOT tactile NOT motion NOT Passy NOT music NOT flow NOT vibration NOT fluid NOT ASIS NOT traditional | Recruiting, Not yet recruiting, Available Studies | Stroke | Deep Brain Stimulation OR magnetic OR transcranial direct current

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

Tracking Information
First Submitted Date  ICMJE November 8, 2019
First Posted Date  ICMJE November 18, 2019
Last Update Posted Date December 3, 2019
Actual Study Start Date  ICMJE December 1, 2019
Estimated Primary Completion Date December 31, 2029   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04166513 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2019)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Transcranial Direct Current Stimulation (tDCS) on Language
Official Title  ICMJE Effects of tDCS on Language Recovery in Post-Stroke Aphasia
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Stroke
  • Aphasia
Intervention  ICMJE
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: Active tDCS with Phonologic-Focused Speech Therapy
    Participants will receive phonologic-focused speech therapy with anodal-tDCS for 10 therapy sessions before.
    Interventions:
    • Device: Transcranial Direct Current Stimulation
    • Behavioral: Phonologic-Focused Speech Therapy
  • Sham Comparator: Sham tDCS with Phonologic-Focused Speech Therapy
    Participants will receive phonologic-focused speech therapy with sham tDCS for 10 therapy sessions.
    Interventions:
    • Device: Sham Transcranial Direct Current Stimulation
    • Behavioral: Phonologic-Focused Speech Therapy
  • Active Comparator: Active tDCS with Semantic-Focused Speech Therapy
    Participants will receive semantic-focused speech therapy with anodal-tDCS for 10 therapy sessions.
    Interventions:
    • Device: Transcranial Direct Current Stimulation
    • Behavioral: Semantic-Focused Speech Therapy
  • Sham Comparator: Sham tDCS with Semantic-Focused Speech Therapy
    Participants will receive semantic-focused speech therapy with sham tDCS for 10 therapy sessions.
    Interventions:
    • Device: Sham Transcranial Direct Current Stimulation
    • Behavioral: Semantic-Focused Speech Therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 14, 2019)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2029
Estimated Primary Completion Date December 31, 2029   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Samantha Drane 414-955-5891 sdrane@mcw.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04166513
Other Study ID Numbers  ICMJE 33162
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sara Pillay, Medical College of Wisconsin
Study Sponsor  ICMJE Medical College of Wisconsin
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sara Pillay, PhD Medical College of Wisconsin
PRS Account Medical College of Wisconsin
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP