Effects of Transcranial Direct Current Stimulation in Post-stroke Aphasia

Sponsor
Johns Hopkins University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02622945
Collaborator
(none)
0
1
2
76
0

Study Details

Study Description

Brief Summary

This study aims to determine whether transcranial direct current stimulation (tDCS) paired with speech-language therapy is more beneficial than speech-language therapy alone in acute and chronic post-stroke aphasia.

Condition or Disease Intervention/Treatment Phase
  • Device: Active tDCS plus Speech-Language Therapy
  • Device: Sham plus Speech-Language Therapy
N/A

Detailed Description

This study aims to determine whether behavioral word-retrieval therapy coupled with anodal tDCS will improve the fluency and name retrieval performance of participants with post-stroke aphasia more efficiently and for greater duration than language therapy alone (i.e. in the sham condition).

tDCS neuronal targets will be selected in this order:

  1. left posterior superior-middle temporal gyrus (an area critical for word retrieval and word comprehension),

  2. left posterior frontal areas found to be responsible for lexical selection if the first area is infarcted, or

  3. right cerebellum (important for learning, and consistently activated in naming task) if both of the other areas are infarcted.

The same areas will be stimulated during the first tDCS and sham periods. If the participant returns for a second period of tDCS and sham with language therapy, the right cerebellum will be stimulated (if it was the only uninfarcted target area investigators will stimulate this area again). For cerebellar stimulation, either anodal or cathodal will be used as studies show that anodal or cathodal stimulation has an effect on cognitive functions.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Transcranial Direct Current Stimulation in Acute and Chronic Post-stroke Aphasia
Study Start Date :
Feb 1, 2014
Anticipated Primary Completion Date :
Jun 1, 2020
Anticipated Study Completion Date :
Jun 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Active tDCS plus Speech-Language Therapy

Active tDCS will be applied at the beginning of 45min speech-language therapy session and will last for 20 min. Language therapy will be oral and written naming. This is a cross-over study so all participants will receive this arm but the order will be randomized.

Device: Active tDCS plus Speech-Language Therapy
Stimulation will be delivered by a battery-driven constant current stimulator. The electrical current will be administered to a pre-specified region of the brain not affected by the lesion(perilesional areas, right hemisphere or cerebellum). The stimulation will be delivered at an intensity of 2mA (estimated current density 0.04 mA/cm2; estimated total charge 0.048C/cm2) in a ramp-like fashion for a maximum of 20 minutes. Speech-language therapy will be oral and written naming.
Other Names:
  • Active tDCS and speech-therapy
  • Sham Comparator: Sham plus Speech-Language Therapy

    Sham tDCS will be applied at the beginning of 45min speech-language therapy session. Language therapy will be oral and written naming. This is a cross-over study so all participants will receive this arm but the order will be randomized.

    Device: Sham plus Speech-Language Therapy
    Speech-Language therapy will be administered during sham stimulation. Current will be administered in a ramp-line fashion but after the ramping the intensity will drop to 0 mA. Speech-language therapy will be oral and written naming.
    Other Names:
  • Sham tDCS plus speech-therapy
  • Outcome Measures

    Primary Outcome Measures

    1. Change in picture naming scores in trained and untrained items [Before and after 15 sessions of intervention (3 weeks) and at 2 weeks and 2 months follow-ups]

    Secondary Outcome Measures

    1. Change in Philadelphia Naming Test: Picture naming of everyday objects, different from training set [Before and after 15 sessions of intervention (3 weeks) and at 2 weeks and 2 months follow-ups]

    2. Change in Written naming of objects and actions [Before and after 15 sessions of intervention (3 weeks) and at 2 weeks and 2 months follow-ups]

      The investigators will evaluate the absolute number as well as the percent change of the list of objects and actions assigned for intervention as trained and untrained items.

    3. Change in working memory (digit span) [Before and after 15 sessions of intervention (3 weeks) and at 2 weeks and 2 months follow-ups]

    4. Change in verbal fluency [Before and after 15 sessions of intervention (3 weeks) and at 2 weeks and 2 months follow-ups]

      The investigators will use letter (F, A, S) and semantic fluency measures (animals, fruits and vegetables) and the investigators will measure how many were added or omitted at follow-up intervals.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Clinically diagnosed with with post-stroke aphasia and word-retrieval deficits

    • Premorbid speakers of English

    • Diagnosis will be based on neuropsychological testing, language testing (most commonly the Western Aphasia Battery), MRI and clinical assessment

    • Stroke size: any l

    • Location: Left hemisphere strokes only from any etiology.

    • Time since stroke onset: 1 day to 20 years.

    Exclusion Criteria:
    • uncorrected visual or hearing impairment by self report

    • other premorbid neurological disorder affecting the brain

    • any other language-based learning disorder or other neurodegenerative disorder such as Alzheimer's Disease or Primary Progressive Aphasia

    • premorbidly diagnosed with a developmental language disorder

    • Pregnant women will also be excluded

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Johns Hopkins Medicine Baltimore Maryland United States 21287

    Sponsors and Collaborators

    • Johns Hopkins University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Johns Hopkins University
    ClinicalTrials.gov Identifier:
    NCT02622945
    Other Study ID Numbers:
    • NA00078932
    First Posted:
    Dec 7, 2015
    Last Update Posted:
    Nov 26, 2018
    Last Verified:
    Nov 1, 2018
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 26, 2018