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HD-tDCS for Phonological Impairment in Aphasia

Sponsor
Medical College of Wisconsin (Other)
Overall Status
Recruiting
CT.gov ID
NCT06010030
Collaborator
(none)
200
Enrollment
1
Location
2
Arms
112.3
Anticipated Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Targeted Transcranial Direct Current Stimulation
  • Behavioral: Speech Therapy
 N/A

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 2 speech therapy groups as well as randomly assigned to one of 2 stimulation groups (active anodal stimulation or sham). Patients will receive one of two different speech therapy treatment interventions to focus on specific processing deficits. Participants will undergo neuropsychological evaluation and fMRI assessment before receiving targeted anodal-tDCS or sham-tDCS for 10 therapy sessions. Participants will then be re-tested using the behavioral assessment measure and fMRI before crossing over to receive the tDCS intervention again, along with the same speech therapy arm. They will complete a behavioral assessment and fMRI at 3 months post Treatment 2 and a final behavioral assessment at 6 months post Treatment 2.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Participants will maintain one of two speech therapy modalities throughout the study and be assigned to either targeted anodal-tDCS or sham-tDCS.Participants will maintain one of two speech therapy modalities throughout the study and be assigned to either targeted anodal-tDCS or sham-tDCS.
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description:
Care provider, participant, and outcome assessor are masked for tDCS status.
Primary Purpose:
Treatment
Official Title:
A Randomized Clinical Trial of tDCS to Remediate Phonological Impairment in Aphasia
Anticipated Study Start Date :
Aug 25, 2023
Anticipated Primary Completion Date :
Jan 1, 2033
Anticipated Study Completion Date :
Jan 1, 2033

Arms and Interventions

Arm Intervention/Treatment
Experimental: HD-tDCS

Participants will be randomized to receive either anodal HD-tDCS or sham-tDCS.

Device: Targeted 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. Anodal or sham tDCS will be administered.
Other Names:
  • HD-tDCS
  • tDCS

    		•
    Experimental: Speech Therapy

    Participants will be randomized to receive either phonologic-focused speech therapy or semantic-focused speech therapy

    Behavioral: Speech Therapy
    Participants will receive either semantic or phonological focused speech therapy

    Outcome Measures

    Primary Outcome Measures

    1. Behavioral outcome [Upon the completion of therapy cycle (a cycle consists of 10 intervention days) and 10 weeks post completion of therapy]

      Percent improvement on behavioral outcomes after each therapy cycle will be the primary behavioral outcome measure.

    Secondary Outcome Measures

    1. fMRI [3 time points: pre-assessment, 10 weeks post-therapy cycle A and 10 weeks post-therapy cycle B]

      fMRI functional changes between time points

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients must be 18 or older.

    Patients may not be older than 85.

    Patients must have a language deficit from left-sided focal neurologic damage (e.g. stroke, tumor).

    Patients must be adults and have English-language fluency.

    Patients must be eligible to undergo MRI.

    Beyond meeting the inclusion criteria, no preference will be given on the basis of race, ethnicity or gender.

    Exclusion Criteria:
    • Advanced neurodegenerative disease (i.e. Stage 3 Alzheimer's disease)

    Neurologic disease (e.g. idiopathic epilepsy, seizure disorders that are not well managed, Parkinson's disease, ALS),

    Severe psychopathology (e.g. schizophrenia, bipolar disorder, acute major depressive episode)

    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, inability to see or hear stimulus materials.

    Younger than 18 or older than 85.

    < 6 months post tumor resection.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical College of Wisconsin Milwaukee Wisconsin United States 53226

    Sponsors and Collaborators

    • Medical College of Wisconsin

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Sara Pillay, Assistant Professor, Medical College of Wisconsin
    ClinicalTrials.gov Identifier:
    NCT06010030
    Other Study ID Numbers:
    • PRO00046308
    First Posted:
    Aug 24, 2023
    Last Update Posted:
    Aug 25, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Aphasia
    Articulation Disorders

    Study Results

    No Results Posted as of Aug 25, 2023