Brain Stimulation and Aphasia Treatment

Phase 2

Completed

• Conditions: Aphasia
• Interventions: Device: Activa Dose II Sham tDCS; Device: Activa Dose II Real tDCS

• Registration Number: NCT01686373
• Lead Sponsor: University of South Carolina

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."

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-09-07
• Study First Submitted QC: 2012-09-12
• Study First Posted: 2012-09-18
• Primary Completion: 2017-05
• Study Completion: 2017-10
• Results First Submitted: 2019-04-17
• Status Verified: 2019-07
• Results First Submitted QC: 2019-07-31
• Last Update Submitted: 2019-07-31
• Results First Posted: 2019-08-20
• Last Update Posted: 2019-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Activa Dose II Sham tDCS	Activa Dose II Sham tDCS	Sham delivery of electrical stimulation
Activa Dose II Real tDCS	Activa Dose II Real tDCS	Actual delivery of electrical stimulation

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

University of South Carolina (USC); 🇺🇸 Columbia, South Carolina, United States