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NCT04777214

TMS in Aphasia Recovery

Completed NA Results posted Last updated 26 November 2021
What this trial tests

NA trial testing Repetitive Transcranial Magnetic Stimulation in Aphasia in 24 participants. Completed in 30 August 2011.

Timeline
26 June 2007
Primary endpoint
30 August 2011
30 August 2011

Quick facts

Lead sponsorUniversity of Pennsylvania
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment24
Start date26 June 2007
Primary completion30 August 2011
Estimated completion30 August 2011
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Pennsylvania

Who can join

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 Test Primary · 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)

GroupValue95% CI
Active TMS 2-month Follow-Up10.3± 20.0
Active TMS 6-month Follow-Up37.7± 31.2
Picture Description of the Boston Diagnostic Aphasia Exam Secondary · 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.

GroupValue95% CI
Active TMS10.4± 16.3
Sham TMS1.2± 15.0
Boston Diagnostic Aphasia Exam - Word Discrimination Subtest Secondary · 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)

GroupValue95% CI
Active TMS1.78± 6.83
Sham TMS0.32± 1.51
Boston Diagnostic Aphasia Examination - Commands Subtest Secondary · 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.

GroupValue95% CI
Active TMS2.22± 12.08
Sham TMS8.00± 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.

Verify or expand the search:

Other trials of Repetitive Transcranial Magnetic Stimulation

Trials testing the same drug.

Other recruiting trials for Aphasia

Currently open trials in the same condition.

Other University of Pennsylvania trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing