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NCT03651700 · ClinicalTrials.gov registry record · Phase 2

Transcranial Magnetic Stimulation and Constraint Induced Language Therapy for Chronic Aphasia

A Phase 2 study of Aphasia, sponsored by H. Branch Coslett.

Completed
Registry status
Phase 2
Development phase
86
Enrollment target
1
Study location

NCT03651700 is a Phase 2 study of Aphasia that has completed, run by H. Branch Coslett. The registered enrollment target is 86 participants, roughly in line with the 81-participant average among 42 other Aphasia trials with a reported enrollment target. The trial reports 1 study location across 1 state.

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The verdict

NCT03651700, a Phase 2 study of Aphasia, has completed, sponsored by H. Branch Coslett.

COMPLETED
Registry status
Phase 2
Development phase
86 participants
Enrollment target
1
Study location

Study Summary

Transcranial Magnetic Stimulation (TMS) has been demonstrated to improve language function in subjects with chronic aphasia in a number of small studies, many of which did not include a control group. Although the treatment appears promising, data to date do not permit an adequate assessment of the utility of the technique. The investigators propose to study the effects of TMS combined with Constraint Induced Language Therapy (CILT) in 75 subjects with chronic aphasia. Subjects will be randomized in a 2:1 ratio to TMS with CILT or sham TMS with CILT. One Hz TMS at 90% motor threshold will be delivered to the right inferior frontal gyrus for 20 minutes in 10 sessions over 2 weeks; language therapy will be provided for one hour immediately after the conclusion of each session of TMS. Change from baseline in the Western Aphasia Battery Aphasia Quotient at 6 months after the end of TMS treatment will serve as the primary outcome measure.

Conditions Studied

Aphasia

Interventions

  • DEVICE Sham TMS
  • DEVICE Active TMS
  • BEHAVIORAL CILT

Study Locations (1)

Pennsylvania

  • University of Pennsylvania - Philadelphia

Trial Details

FieldValue
Enrollment Target 86 participants
Start Date 2019-03-28
Est. Completion 2024-08-31
Phase Phase 2

Sponsor

H. Branch Coslett

1 total trials

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What the Registry Record Tells You About NCT03651700

The ClinicalTrials.gov registry entry for NCT03651700 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 86 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 81-participant average among 42 other Aphasia trials with a reported enrollment target. The listed sponsor is H. Branch Coslett, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Aphasia appearing as the primary indexed condition, and to 3 interventions - of which Sham TMS is the first listed.

NCT03651700 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT03651700 about?

NCT03651700 is a clinical study titled "Transcranial Magnetic Stimulation and Constraint Induced Language Therapy for Chronic Aphasia". Transcranial Magnetic Stimulation (TMS) has been demonstrated to improve language function in subjects with chronic aphasia in a number of small studies, many of which did not include a control group. Although the treatment appears promising, data to date do not permit an adequate assessment of the ...

What is the current status of trial NCT03651700?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 86 participants. The study started on 2019-03-28. Estimated completion is 2024-08-31.

What conditions does trial NCT03651700 study?

This clinical trial studies the following conditions: Aphasia.

What interventions are being tested in trial NCT03651700?

The interventions under investigation include: Sham TMS (DEVICE), Active TMS (DEVICE), CILT (BEHAVIORAL).

Who is sponsoring clinical trial NCT03651700?

This trial is sponsored by H. Branch Coslett, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03651700 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.