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N/A N=58 Randomized Quadruple-blind Treatment

Stimulating Language in Subacute StrokE

Stroke

Enrolled (actual)
58
Serious AEs
7.8%
Results posted
Sep 2022
Primary outcome: Primary: Change in Accuracy of Naming Untrained Pictures (Philadelphia Naming Test (PNT)) Pre-treatment to 1 Week Post-treatment — 22.3; 18.5 score on a scale — p=0.54

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
A-tDCS (1 mA) (Device); SALT (Behavioral); Sham (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Johns Hopkins University
Primary completion
Nov 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Accuracy of Naming Untrained Pictures (Philadelphia Naming Test (PNT)) Pre-treatment to 1 Week Post-treatment
22.3; 18.5 0.54
SECONDARY
Change in Accuracy of Naming Untrained Pictures (Philadelphia Naming Test) Pre-treatment to 5-weeks Post-treatment
29.95; 20.82
SECONDARY
Change in Content of Picture Description Pre-treatment to 1 Week Post-treatment
4.10; 1.66
SECONDARY
Change in Efficiency of Picture Description Pre-treatment to 1 Week Post-treatment
-12.23; -1.29
SECONDARY
Change in Content of Picture Description Pre-treatment to 5 Weeks Post-treatment
5.42; 1.42
SECONDARY
Change in Efficiency of Picture Description Pre-treatment to 5 Weeks Post-treatment
-12.64; 2.47
SECONDARY
Change in Stroke Impact Scale (SIS) Pre-treatment to Post-treatment
2.56; 3.85
SECONDARY
Change in Stroke Impact Scale (SIS) Pre-treatment to 5 Weeks Post-treatment
2.08; 4.18
SECONDARY
Change in Accuracy of Naming Untrained Pictures (Philadelphia Naming Test) Pre-treatment to 20-weeks Post-treatment
34.04; 25.55
SECONDARY
Change in Content of Picture Description Pre-treatment to 20-weeks Post-treatment
5.15; 3.28
SECONDARY
Change in the Efficiency of Picture Description Pre-treatment to 20 Weeks Post-treatment
-14.75; 6.53
SECONDARY
Change in Stroke Impact Scale (SIS) Pre-treatment to 20 Weeks Post-treatment
2.60; 4.28

Summary

The investigators will study the effects of transcranial direct current (tDCS) stimulation during language therapy for naming in individuals with aphasia in the acute and subacute post stroke period. Naming difficulties are a persistent and common symptom in aphasia after left-hemisphere (LH) stroke. Behavioral therapy (speech and language therapy; SALT) is the mainstay treatment for post stroke aphasia. Transcranial direct cortical stimulation (tDCS) is a promising adjunct to traditional SALT. tDCS is a safe, non-invasive, non-painful electrical stimulation of the brain which modulates cortical excitability by application of weak electrical currents in the form of direct current brain polarization. It is usually administered via saline-soaked surface sponge electrodes attached to the scalp and connected to a direct current stimulator with low intensities. Most studies are conducted in the chronic phase after stroke. Because neuroplasticity is greatest early after stroke, there is reason to believe tDCS might be most effective in the acute-subacute period. However, only two studies have evaluated tDCS paired with language therapy in group studies of acute to subacute aphasic stroke patients and only one of these was sham-controlled. Furthermore, no studies (of which we are aware) have combined tDCS with therapy to facilitate naming in post stroke aphasia, as shown to be effective in studies of chronic stroke. In this study, the investigators will evaluate whether tDCS combined with SALT improves naming in individuals with aphasia in the acute and subacute post stroke period, more than SALT alone in a randomized, double-blind, sham-controlled trial. The investigators will test the hypothesis that anodal tDCS (A-tDCS) over a targeted region and computer-delivered SALT is associated with greater gains in accuracy in naming pictures, compared to sham combined with the same computer-delivered SALT in post stroke aphasia.

Eligibility Criteria

Inclusion Criteria

  • Participant Inclusion Criteria

Participants must satisfy the following inclusion criteria to be considered eligible for entry into this study:

  • Participants must have sustained an acute ischemic left hemisphere stroke.
  • Participants must be fluent speakers of English by self-report.
  • Participants must be capable of giving informed consent or indicating another to provide informed consent.
  • Participants must be age 18 or older.
  • Participants must be premorbidly right handed.
  • Participants must be within 3 months of onset of stroke.
  • Participants must have an aphasia diagnosis as confirmed by the Western Aphasia Battery-Revised.
  • Participants must achieve at least 65% accuracy on screening task (comparable to treatment task) on 1 of 3 attempts

Exclusion Criteria

  • Participant Exclusion Criteria

Participants with any of the following characteristics will not be eligible for entry into this study:

  • Previous neurological or psychiatric disease, including previous symptomatic stroke.
  • Seizures during the previous 12 months.
  • Uncorrected visual loss or hearing loss by self-report.
  • Use of medications that lower the seizure threshold (e.g., methylphenidate, amphetamine salts).
  • Use of N-methyl-D-aspartate (NMDA) antagonists (e.g., memantine).
  • History of brain surgery or any metal in the head.
  • Scalp sensitivity (per participant report).
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02674490). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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