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.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 1 Secondary · Reporting Duration: 6-months post-treatment
6-months post-treatment
Change in PNT
Change in WAB-AQ
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
2 Treatment Groups
Active TMS
1 of 2
Sham TMS
1 of 2
Active Control
Non-Treatment Group
83 Total Participants · 2 Treatment Groups
Primary Treatment: Active TMS · Has Placebo Group · Phase 2
Active TMSActiveComparator Group · 2 Interventions: Active TMS, CILT · Intervention Types: Device, Behavioral
Sham TMSShamComparator Group · 2 Interventions: Sham TMS, CILT · Intervention Types: Device, Behavioral
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6-months post-treatment
Who is running the clinical trial?
H. Branch CoslettLead Sponsor
National Institutes of Health (NIH)NIH
2,472 Previous Clinical Trials
24,591,073 Total Patients Enrolled
8 Trials studying Aphasia
1,689 Patients Enrolled for Aphasia
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
292 Previous Clinical Trials
175,732 Total Patients Enrolled
35 Trials studying Aphasia
2,535 Patients Enrolled for Aphasia
H. Branch Coslett, MD4.04 ReviewsPrincipal Investigator - University of Pennsylvania
University of Pennsylvania
2 Previous Clinical Trials
54 Total Patients Enrolled
1 Trials studying Aphasia
24 Patients Enrolled for Aphasia
Eligibility Criteria
Age 18 - 80 · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You had a stroke at least 6 months ago.
References
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- Medina, Jared, Catherine Norise, Olufunsho Faseyitan, H. Branch Coslett, Peter E. Turkeltaub, and Roy H. Hamilton. 2012. “Finding the Right Words: Transcranial Magnetic Stimulation Improves Discourse Productivity in Non-fluent Aphasia After Stroke”. Aphasiology. Informa UK Limited. doi:10.1080/02687038.2012.710316.
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- Hamilton, Roy H., Linda Sanders, Jennifer Benson, Olufunsho Faseyitan, Catherine Norise, Margaret Naeser, Paula Martin, and H. Branch Coslett. 2010. “Stimulating Conversation: Enhancement of Elicited Propositional Speech in a Patient with Chronic Non-fluent Aphasia Following Transcranial Magnetic Stimulation”. Brain and Language. Elsevier BV. doi:10.1016/j.bandl.2010.01.001.
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- Avenanti, A., M. Coccia, E. Ladavas, L. Provinciali, and M. G. Ceravolo. 2012. “Low-frequency Rtms Promotes Use-dependent Motor Plasticity in Chronic Stroke: A Randomized Trial”. Neurology. Ovid Technologies (Wolters Kluwer Health). doi:10.1212/wnl.0b013e3182436558.
- Hamilton, Roy H., Linda Sanders, Jennifer Benson, Olufunsho Faseyitan, Catherine Norise, Margaret Naeser, Paula Martin, and H. Branch Coslett. 2010. “Stimulating Conversation: Enhancement of Elicited Propositional Speech in a Patient with Chronic Non-fluent Aphasia Following Transcranial Magnetic Stimulation”. Brain and Language. Elsevier BV. doi:10.1016/j.bandl.2010.01.001.
- Martin, Paula, Margaret Naeser, Hugo Theoret, Jose Maria Tormos, Marjorie Nicholas, Jacquie Kurland, Felipe Fregni, Heidi Seekins, Karl Doron, and Alvaro Pascual-Leone. 2004. “Transcranial Magnetic Stimulation as a Complementary Treatment for Aphasia”. Seminars in Speech and Language. Georg Thieme Verlag KG. doi:10.1055/s-2004-825654.
- Medina, Jared, Catherine Norise, Olufunsho Faseyitan, H. Branch Coslett, Peter E. Turkeltaub, and Roy H. Hamilton. 2012. “Finding the Right Words: Transcranial Magnetic Stimulation Improves Discourse Productivity in Non-fluent Aphasia After Stroke”. Aphasiology. Informa UK Limited. doi:10.1080/02687038.2012.710316.
- Naeser, Margaret A., Paula I. Martin, Kristine Lundgren, Reva Klein, Jerome Kaplan, Ethan Treglia, Michael Ho, Marjorie Nicholas, Miguel Alonso, and Alvaro Pascual-Leone. 2010. “Improved Language in a Chronic Nonfluent Aphasia Patient After Treatment with CPAP and TMS”. Cognitive and Behavioral Neurology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/wnn.0b013e3181bf2d20.
- NAESER, M, P MARTIN, M NICHOLAS, E BAKER, H SEEKINS, M KOBAYASHI, H THEORET, F FREGNI, J MARIATORMOS, and J KURLAND. 2005. “Improved Picture Naming in Chronic Aphasia After TMS to Part of Right Broca?s Area: An Open-protocol Study”. Brain and Language. Elsevier BV. doi:10.1016/j.bandl.2004.08.004.
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- H. Branch Coslett 2019. "Transcranial Magnetic Stimulation and Constraint Induced Language Therapy for Chronic Aphasia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03651700.
Frequently Asked Questions
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." - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
Unverified Answer
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." - Anonymous Online Contributor
Unverified Answer