Adults 18 to 75, any sex, with Aphasia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Boston Naming TestPrimary· Baseline, 2 months and 6-months after the last rTMS treatment session
The Boston Naming Test is an assessment of confrontation naming, where a score ranges from 0 (no items named correctly) to 36 (all items named correctly)
Group
Value
95% CI
Active TMS 2-month Follow-Up
10.3
± 20.0
Active TMS 6-month Follow-Up
37.7
± 31.2
Picture Description of the Boston Diagnostic Aphasia ExamSecondary· Baseline and 2 months after the last rTMS treatment session
The picture description of the Boston Diagnostic Aphasia Exam is a measurement of spontaneous speech, elicited by a picture description. It is not a scale. Quantitative Production Analysis (QPA) is used to analyze the production of words related to the picture stimulus. Total number of Narrative Words produced, defined as total words minus stereotyped utterances, task-related comments, or comments cued by administrator, was determined using QPA as a measure of discourse productivity.
Group
Value
95% CI
Active TMS
10.4
± 16.3
Sham TMS
1.2
± 15.0
Boston Diagnostic Aphasia Exam - Word Discrimination SubtestSecondary· Baseline and 2 months after the last rTMS treatment session
The Boston Diagnostic Aphasia Exam - Word Discrimination Subtest is an assessment of auditory comprehension via word discrimination, where a score ranges from 0 (no items correct) to 72 (all items correct)
Group
Value
95% CI
Active TMS
1.78
± 6.83
Sham TMS
0.32
± 1.51
Boston Diagnostic Aphasia Examination - Commands SubtestSecondary· Baseline and 2 months after the last rTMS treatment
The Boston Diagnostic Aphasia Examination - Commands Subtest is an assessment of auditory comprehension via command following, where a score ranges from 0 (no items correctly performed) to 15 (all items correctly performed). Percent change was calculated by taking the mean performance at 2-months after rTMS treatment and subtracting mean performance at baseline, then dividing by the mean baseline performance and multiplying by 100.
Group
Value
95% CI
Active TMS
2.22
± 12.08
Sham TMS
8.00
± 10.26
Sponsor's own description
Stroke often causes substantial problems in speaking or understanding speech. Treatments for these problems are currently very limited. Limited studies to date suggest that repetitive Transcranial Magnetic Stimulation (TMS) to the side of the brain opposite to the side on which the stroke occurred may improve language function. The investigators are testing this hypothesis by giving daily 20 minute sessions of repeated TMS to the right (unaffected) side of the brain; the investigators test language function with a variety of tests both before and after the treatment with TMS and subjects are required to undergo functional MRI scans before and after treatment. TMS is a procedure in which a coil is placed next to the head of the subject and an electrical current passes through the coil causing a magnetic field that, in turn, causes a small electric current in the portion of the brain underneath the coil.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Pennsylvania
Last refreshed: 26 November 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04777214.