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Effects of Transcranial Direct Current Stimulation in Post-stroke Aphasia

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ClinicalTrials.gov Identifier: NCT02622945
Recruitment Status : Recruiting
First Posted : December 7, 2015
Last Update Posted : August 23, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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
Aphasia Device: Active tDCS plus Speech-Language Therapy Device: Sham plus Speech-Language Therapy Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 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 : February 2014
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia

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 Name: 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 Name: Sham tDCS plus speech-therapy




Primary Outcome Measures :
  1. Change in picture naming scores in trained and untrained items [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: Before and after 15 sessions of intervention (3 weeks) and at 2 weeks and 2 months follow-ups ]
  4. Change in verbal fluency [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02622945


Contacts
Contact: Kyrana Tsapkini, PhD 410-614-2464 tsapkini@jhmi.edu
Contact: Argye Hillis, MD 410-614-2381 argye@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Medicine Recruiting
Baltimore, Maryland, United States, 21287
Contact: Argye Hillis, MD    410-614-2381    argye@jhmi.edu   
Principal Investigator: Kyrana Tsapkini, PhD         
Principal Investigator: Argye Hillis, MD         
Sub-Investigator: Rajani Sebastian, PhD         
Sponsors and Collaborators
Johns Hopkins University

Publications:
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02622945     History of Changes
Other Study ID Numbers: NA00078932
First Posted: December 7, 2015    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms