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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-months post-treatment

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in WAB-AQ

Secondary outcome measures

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute on Deafness and Other Communication Disorders (NIDCD)NIH

328 Previous Clinical Trials

178,213 Total Patients Enrolled

37 Trials studying Aphasia

2,706 Patients Enrolled for Aphasia

H. Branch CoslettLead Sponsor

National Institutes of Health (NIH)NIH

2,696 Previous Clinical Trials

6,952,456 Total Patients Enrolled

8 Trials studying Aphasia

1,719 Patients Enrolled for Aphasia

Media Library

Active TMS (Transcranial Magnetic Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT03651700 — Phase 2

Aphasia Research Study Groups: Active TMS, Sham TMS

Aphasia Clinical Trial 2023: Active TMS Highlights & Side Effects. Trial Name: NCT03651700 — Phase 2

Active TMS (Transcranial Magnetic Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03651700 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

May I join the research endeavor?

"Eligibility requirements for this medical trial state that participants must be diagnosed with aphasia and between the ages of 18-80. A maximum of 83 patients may join the study."

Answered by AI

Has Transcranial Magnetic Stimulation been validated by the FDA?

"As this is a Phase 2 Clinical Trial, with minimal evidence for efficacy and some data to support safety, our team at Power has assigned Active TMS a score of 2."

Answered by AI

Is the age of consent sufficient to qualify for enrollment in this research?

"This research is looking for participants who are aged 18 years and above, but below 80."

Answered by AI

How many participants are being accepted into this research endeavor?

"Affirmative. Clinicaltrials.gov data suggests that participant recruitment for this medical trial, which commenced on March 28th 2019, is ongoing. This project seeks 83 test subjects from a single site."

Answered by AI

Are there any remaining vacancies in this experiment for participants?

"The clinicaltrials.gov website shows that this research is currently recruiting participants. The trial was initially launched on March 28th 2019 and its details were recently updated on August 15th 2022."

Answered by AI

Recent research and studies

Journal of Speech, Language, and Hearing ResearchJournal

A System for Quantifying the Informativeness and Efficiency of the Connected Speech of Adults with Aphasia

Nicholas, Linda E., and Robert H. Brookshire. 1993. “A System for Quantifying the Informativeness and Efficiency of the Connected Speech of Adults with Aphasia”. Journal of Speech, Language, and Hearing Research. American Speech Language Hearing Association. doi:10.1044/jshr.3602.338.

StrokeJournal

Effects of Noninvasive Brain Stimulation on Language Networks and Recovery in Early Poststroke Aphasia

Thiel, Alexander, Alexander Hartmann, Ilona Rubi-Fessen, Carole Anglade, Lutz Kracht, Nora Weiduschat, Josef Kessler, Thomas Rommel, and Wolf-Dieter Heiss. 2013. “Effects of Noninvasive Brain Stimulation on Language Networks and Recovery in Early Poststroke Aphasia”. Stroke. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/strokeaha.111.000574.

StrokeJournal

Constraint-induced Therapy of Chronic Aphasia After Stroke

Pulvermüller, Friedemann, Bettina Neininger, Thomas Elbert, Bettina Mohr, Brigitte Rockstroh, Peter Koebbel, and Edward Taub. 2001. “Constraint-induced Therapy of Chronic Aphasia After Stroke”. Stroke. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/01.str.32.7.1621.

NeurologyJournal