Transcranial Direct Current Stimulation Investigations of Language Processing in Aphasia
1 other identifier
interventional
25
0 countries
N/A
Brief Summary
This study proposes to use transcranial direct current stimulation (tDCS) in patients with chronic strokes and aphasia in order to characterize and enhance the mechanisms of language recovery following injury. Prior to enrollment subjects will undergo six "site-finding' sessions involving various placements of positively charged (anodal), negatively charged (cathodal), and sham stimulation over the damaged and intact hemispheres of the brain, along with standard tests of language. Subjects who are found to experience a transient improvement in language ability in this initial experiment will participate in an incomplete cross-over design study to determine if 10 sessions of tDCS stimulation lead to prolonged language benefit when delivered to the hemisphere and at the polarity shown previously to respond best to stimulation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2010
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 11, 2019
CompletedFirst Posted
Study publicly available on registry
August 1, 2019
CompletedAugust 1, 2019
July 1, 2019
4.9 years
July 11, 2019
July 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in naming ability after tDCS at different brain areas
We will contrast naming ability before and after daily tDCS at 5 different brain regions. A change in naming ability as a function of tDCS to a specific brain region will be taken as evidence that stimulation of that brain region is relevant to the performance of the behavioral task in question.
2 weeks
Change in overall aphasia severity after tDCS treatment
We will contrast overall aphasia severity before and after tDCS comparing real vs. sham stimulation. A decrease in aphasia severity which is greater at real stimulation vs. sham stimulation suggests that tDCS may be a viable tool to improving language in post-stroke aphasia.
Through study completion, about 2 months
Study Arms (3)
Site-Finding
EXPERIMENTALEach subject will receive anodal, cathodal, and sham stimulation to both the ipsilesional and contralesional hemispheres in a series of six sessions (one condition per session), each separated by at least two days. During anodal and cathodal tDCS sessions, subjects will receive stimulation for 20 minutes with a current of 2.0 mA using a 5x5 cm electrode. During sham tDCS, a 2.0 mA current will be delivered for approximately 30 seconds before being extinguished over a course of seconds. The participant will complete pre/post language testing at each session in order to determine if the subject is a tDCS responder and if so, which site produces the best transient language improvement in that individual. Subjects who do not respond to tDCS will not be invited to move forward to the treatment phase.
Real tDCS
ACTIVE COMPARATORHalf of our tDCS responders will be randomized to a group receiving 10 sessions (divided in to two five-day periods) of real tDCS. During real tDCS sessions, subjects will receive stimulation for 20 minutes at a current of 2.0 mA with a 5x5 cm electrode at their optimal responder site previously determined.
Sham tDCS
SHAM COMPARATORHalf of our tDCS responders will be randomized to a group receiving 10 sessions (divided in to two five-day periods) of sham tDCS. During sham tDCS, a 2.0 mA current will be delivered for approximately 30 seconds at the beginning of the sham condition before being extinguished over the course of seconds. Individuals randomized into the sham arm will be offered the option to crossover to real tDCS after their participation is complete.
Interventions
Transcranial direct current stimulation (tDCS) is a form of non-invasive neuromodulation that uses constant, low (1-2mA), direct current delivered via electrodes on the head.
Eligibility Criteria
You may qualify if:
- \. Presence of aphasia attributable to one or more unilateral left hemispheric stroke(s)
- \. Must speak English as a native language
- \. Must be able to understand the nature of the study, and give informed consent
You may not qualify if:
- \. Subjects with bilateral strokes.
- \. History of neurologic illness(es) other than stroke
- \. Current unstable medical illness(es)
- \. Epilepsy or Seizure(s) within the last six months
- \. Subjects with metallic objects in the face or head other than dental apparatus such as braces, fillings, and implants.
- \. Subjects with Pacemakers or ICDs
- \. Diagnosed psychiatric disorders
- \. Pregnancy
- \. Current alcohol or drug abuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Participants will be blinded to which tDCS group (real or sham) they are initially enrolled in; however, since only the sham group crosses over this will signal to subject that they are now getting real stimulation.
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2019
First Posted
August 1, 2019
Study Start
July 1, 2010
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
August 1, 2019
Record last verified: 2019-07