Aphasia
Conditions
Keywords
Aphasia, Brain, Stimulation, Communication, Stoke, Post, Phase II Clinical Trial, Treatment, tDCS, Fridriksson
Brief summary
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.
Detailed description
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.
Interventions
DEVICEActiva Dose II Real tDCS
20 minutes of 1 milliamp active tDCS per treatment day (15 total sessions)
DEVICEActiva Dose II Sham tDCS
20 minutes of sham stimulation per treatment day (15 total sessions)
Sponsors
National Institute on Deafness and Other Communication Disorders (NIDCD)
Medical University of South Carolina
University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients must be willing and able to give informed consent. 2. Patients must be willing and able to comply with study requirements. 3. Patients must be between 25- and 80-years of age. 4. Patients must be native English speakers. 5. Patients must be pre-morbidly right-handed. 6. Patients must have sustained a one-time ischemic stroke in the left-hemisphere. 7. Patients must be greater than 6-months post-stroke. 8. Patients must have an aphasia diagnosis as confirmed by the Western Aphasia Battery-Revised. 9. Patients must be MRI-compatible (e.g., no metal implants, not claustrophobic, etc.). 10. Patients must achieve at least 65% accuracy on naming task during screening -
Exclusion criteria
1. History of brain surgery 2. Seizures during the previous 12 months 3. Sensitive scalp (per patient report) 4. Able to overtly name more than an average of 140 out of 175 items during the pre-treatment picture naming test (Philadelphia Naming Test) during Visits 2 or 3. 5. Unable to overtly name at least an average of 5 out of 80 items during the pre-treatment functional magnetic resonance imaging (fMRI) sessions during Visits 2 or 3.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Philadelphia Naming Test (PNT) Plus the Naming 80 (a Portion of the Trained Items). | Immediately post-treatment | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Activa Dose II Real tDCS Actual delivery of electrical stimulation
Activa Dose II Real tDCS | 34 |
| Activa Dose II Sham tDCS Sham delivery of electrical stimulation
Activa Dose II Sham tDCS | 40 |
| Total | 74 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lost to Follow-up | 3 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Activa Dose II Real tDCS | Total | Activa Dose II Sham tDCS |
|---|---|---|---|
| Age, Continuous | 60 years STANDARD_DEVIATION 11 | 60 years STANDARD_DEVIATION 10 | 60 years STANDARD_DEVIATION 10 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 10 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 27 Participants | 62 Participants | 35 Participants |
| Region of Enrollment United States | 34 participants | 74 participants | 40 participants |
| Sex: Female, Male Female | 10 Participants | 22 Participants | 12 Participants |
| Sex: Female, Male Male | 24 Participants | 52 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 40 |
| other Total, other adverse events | 3 / 34 | 3 / 40 |
| serious Total, serious adverse events | 0 / 34 | 1 / 40 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Activa Dose II Real tDCS | The Philadelphia Naming Test (PNT) Plus the Naming 80 (a Portion of the Trained Items). | 13.9 PNT and Naming 80 score |
| Activa Dose II Sham tDCS | The Philadelphia Naming Test (PNT) Plus the Naming 80 (a Portion of the Trained Items). | 8.2 PNT and Naming 80 score |