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Transcranial Magnetic Stimulation

TMS + CILT for Aphasia

Phase 2

Waitlist Available

Led By H. Branch Coslett, MD

Research Sponsored by H. Branch Coslett

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must be able to understand the nature of the study, and give informed consent

Clinical evidence and MRI or CT verification of a single left hemisphere stroke with moderate to severe aphasia

Must not have

Previous head trauma with loss of consciousness for more than 5 minutes

Multiple strokes (excluding small lacunar strokes) as defined by brain imaging

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-months post-treatment

Summary

This trial will study the effects of combining Transcranial Magnetic Stimulation (TMS) with Constraint Induced Language Therapy (CILT) in subjects with chronic aphasia. The primary outcome measure will be change from baseline in the Western Aphasia Battery Aphasia Quotient at 6 months after the end of TMS treatment.

Who is the study for?

This trial is for individuals with chronic aphasia due to a single left hemisphere stroke that occurred at least 6 months ago. Participants must have moderate to severe speech impairment, verified by MRI or CT, and be able to understand the study and consent. People with multiple strokes (except small ones), substance abuse history, significant head trauma, psychiatric illness, long-term use of certain CNS drugs, or signs of dementia cannot join.

What is being tested?

The trial tests if Transcranial Magnetic Stimulation (TMS) combined with Constraint Induced Language Therapy (CILT) can improve language in people with chronic aphasia. Subjects will either receive real TMS or a sham treatment alongside CILT in sessions over two weeks. The main goal is to see how their language scores change after six months.

What are the potential side effects?

Possible side effects from TMS may include discomfort at the stimulation site, headache, lightheadedness, seizures (rarely), and hearing damage if ear protection isn't used during treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I understand the study's purpose and agree to participate.

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I had a stroke on the left side of my brain and have significant speech difficulties.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a head injury that made me lose consciousness for over 5 minutes.

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I have had multiple strokes, confirmed by brain scans.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-months post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-months post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-months post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in WAB-AQ

Secondary study objectives

Change in PNT

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active TMSActive Control2 Interventions

There will be 10 TMS sessions over 2 consecutive weeks in which 20 minutes (1200 pulses) of 1 Hz active TMS will be delivered to the inferior pars triangular. Each TMS treatment session will be immediately followed by a 60-90 minute session of Constrained Induced Language Therapy (CILT).

Group II: Sham TMSPlacebo Group2 Interventions

There will be 10 TMS sessions over 2 consecutive weeks in which 20 minutes (1200 pulses) of 1 Hz sham TMS will be delivered to the inferior pars triangular. Sham TMS will be administered with a sham TMS coil that looks and sounds like the active coil but does not generate a magnetic field. Each TMS treatment session will be immediately followed by a 60-90 minute session of Constrained Induced Language Therapy (CILT).

0 / 4Eligibility criteria met