A Phase 2 interventional study of Activa Dose II Real tDCS and Activa Dose II Sham tDCS in Aphasia, sponsored by University of South Carolina. Completed at 2 sites in United States. Open to participants aged 25 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-08-20.
Sponsored by University of South Carolina · Phase 2, Interventional, and Treatment
The purpose of this study is to assess the changes in language processing of patients with chronic, post-stroke aphasia following the application of brain stimulation. The brain stimulation the investigators administer is called transcranial direct current stimulation (tDCS). It involves passing a weak electrical current through the brain between two electrodes in the form of damp sponges. One sponge will be placed over a specified area on the damaged left hemisphere, while the other sponge will be placed on the right scalp. Computer-controlled speech-language treatment will be administered during the application of tDCS.
Stroke is the leading cause of adult disability in the United States. Approximately one-third of all strokes result in acute language impairment (aphasia), with approximately one-fifth suffering from chronic aphasia. Unfortunately, the prognosis for moderate to severe chronic aphasia remains grim, as current behavioral treatment approaches usually offer only limited-to-modest benefit. Recent advancements in understanding the relationship between low current electrical brain stimulation and cortical plasticity suggest that the effect of behavioral aphasia treatment could possibly be enhanced using anodal transcranial direct current stimulation (A-tDCS). Indeed, we have shown how A-tDCS can significantly boost the effect of behavioral aphasia treatment. Based on these results as well as our other studies aimed at understanding how favorable brain plasticity correlates with positive treatment outcome in aphasia, we propose to conduct a Phase II clinical trial utilizing a futility design. Consistent with the goals of Program Announcement PAR-08-204 by the National Institute on Deafness and Other Communication Disorders (NIDCD), we plan to "evaluate whether there is sufficient evidence of short term improvement in humans to justify a phase III trial."
365 studies on the registry are indexed under Aphasia; 89 are open to participants now.
This study's enrollment of 74 is above the median of 30 across 316 interventional studies indexed under Aphasia.
Browse Aphasia studies →University of South Carolina is the lead sponsor of 191 studies on the registry; 41 are open to participants now.
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Exclusion Criteria:
Actual delivery of electrical stimulation
Device: Activa Dose II Real tDCS
Sham delivery of electrical stimulation
Device: Activa Dose II Sham tDCS
20 minutes of 1 milliamp active tDCS per treatment day (15 total sessions)
20 minutes of sham stimulation per treatment day (15 total sessions)
The Philadelphia Naming Test (PNT) Plus the Naming 80 (a Portion of the Trained Items).
The PNT includes 175 items and has a minimum score of 0 (zero items named correctly) and a maximum score of 175 (all items named correctly). The Naming 80 includes a portion of the trained treatment items (N=80) with a minimum score of 0 (zero items named correctly) and a maximum score of 80 (all items named correctly). For both scales, higher values represent better outcome. The average of two administrations of the PNT were added to the the average of two administrations of the Naming 80 for both time points. The outcome measure is the change in that value (averaged PNT + averaged Naming 80) from baseline to immediately post-treatment. Only two timepoints are used for this calculation: baseline and immediately post-treatment.
Time frame: Immediately post-treatment
| Milestone | Activa Dose II Real tDCS | Activa Dose II Sham tDCS |
|---|---|---|
| Started | 34 | 40 |
| Received 15 treatment sessions | 33 | 39 |
| Completed | 31 | 38 |
| Not completed | 3 | 2 |
| Withdrew: Lost to follow-up | 3 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Adverse event | 0 | 1 |
The PNT includes 175 items and has a minimum score of 0 (zero items named correctly) and a maximum score of 175 (all items named correctly). The Naming 80 includes a portion of the trained treatment items (N=80) with a minimum score of 0 (zero items named correctly) and a maximum score of 80 (all items named correctly). For both scales, higher values represent better outcome. The average of two administrations of the PNT were added to the the average of two administrations of the Naming 80 for both time points. The outcome measure is the change in that value (averaged PNT + averaged Naming 80) from baseline to immediately post-treatment. Only two timepoints are used for this calculation: baseline and immediately post-treatment.
| PNT and Naming 80 score | Activa Dose II Real tDCS | Activa Dose II Sham tDCS |
|---|---|---|
| The Philadelphia Naming Test (PNT) Plus the Naming 80 (a Portion of the Trained Items). | 13.9 (9.0 to 18.7) | 8.2 (3.8 to 12.6) |
Collected over Non-serious adverse events were collected until immediate post treatment testing sessions (2 weeks), and serious adverse events were collected until end of study (24 weeks).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Activa Dose II Real tDCS | 0/34 (0%) | 0/34 (0%) | 3/34 (8.8%) |
| Activa Dose II Sham tDCS | 0/40 (0%) | 1/40 (2.5%) | 3/40 (7.5%) |
| Event | Activa Dose II Real tDCS | Activa Dose II Sham tDCS |
|---|---|---|
| ConvulsionNervous system disorders | 0/34 | 1/40 |
| Event | Activa Dose II Real tDCS | Activa Dose II Sham tDCS |
|---|---|---|
| ErythemaSkin and subcutaneous tissue disorders | 2/34 | 0/40 |
| DizzinessNervous system disorders | 1/34 | 2/40 |
| HeadacheNervous system disorders | 0/34 | 1/40 |
| HypertensionVascular disorders | 0/34 | 1/40 |
| Age, Continuous(years) | Activa Dose II Real tDCS | Activa Dose II Sham tDCS | Total |
|---|---|---|---|
| Mean | 60 ± 11 | 60 ± 10 | 60 ± 10 |
| Sex: Female, Male(Participants) | Activa Dose II Real tDCS | Activa Dose II Sham tDCS | Total |
|---|---|---|---|
| Female | 10 | 12 | 22 |
| Male | 24 | 28 | 52 |
| Race (NIH/OMB)(Participants) | Activa Dose II Real tDCS | Activa Dose II Sham tDCS | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 1 | 2 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 6 | 4 | 10 |
| White | 27 | 35 | 62 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Activa Dose II Real tDCS | Activa Dose II Sham tDCS | Total |
|---|---|---|---|
| United States | 34 | 40 | 74 |
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University of South Carolina