Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
10 participants
INTERVENTIONAL
2023-01-09
2023-12-31
Brief Summary
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Detailed Description
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TMS is a non-invasive procedure (in other words, it takes place outside your body). A coil will be placed over your head. The coil sends magnetic pulses to your brain to stimulate, or excite, neurons. Most studies using TMS stimulate one area of the brain at a time, but this does not tell us how to improve the network connections between brain areas.
For this study, we plan to stimulate two language areas of the brain to improve these network connections. To do this, we will use a form of TMS called "cortico-cortical paired associative stimulation" (ccPAS). This type of TMS involves applying paired pulses to two different brain areas that have been "disconnected" from each other after a stroke. The pulses are delivered with a time difference, on other words, one pulse after another.
If you choose to participate, you will be randomly assigned to one of two groups. There is a 50% chance you will receive active brain stimulation with speech-language therapy and a 50% chance that you will receive inactive or sham stimulation (no brain stimulation) along with speech-language therapy. Neither you nor the clinician on the research project will choose - or know - which group you are assigned to. Only the person administering the stimulation will know.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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ccPAS group
Patients under this group will receive ccPAS followed by speech-language therapy.
Cortico-cortical paired associative stimulation
Two brain areas will be stimulated with transcranial magnetic stimulation pulses. The pulses will be delivered with a time difference, on other words, one pulse after another.
Sham ccPAS group
Patients under this group will receive sham ccPAS followed by speech-language therapy.
Sham cortico-cortical paired associative stimulation
Two brain areas will be stimulated with sham transcranial magnetic stimulation. The sham pulses will be delivered with a time difference, on other words, one pulse after another.
Interventions
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Cortico-cortical paired associative stimulation
Two brain areas will be stimulated with transcranial magnetic stimulation pulses. The pulses will be delivered with a time difference, on other words, one pulse after another.
Sham cortico-cortical paired associative stimulation
Two brain areas will be stimulated with sham transcranial magnetic stimulation. The sham pulses will be delivered with a time difference, on other words, one pulse after another.
Eligibility Criteria
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Inclusion Criteria
2. ≧ six months post-stroke onset
3. WAB-R Fluency, Grammatical Competence, and Paraphasias Score between 2-6
4. 18+ years of age
5. Premorbidly right-handed
6. English-speaking
7. Ability to participate in fMRI / TMS protocol
Exclusion Criteria
2. Metal in the body (rods, plates, screws, shrapnel, dentures, IUD) or metallic particles in the eye
3. Surgical clips in the head or previous neurosurgery
4. Any magnetic particles in the body
5. Cochlear implants
6. Prosthetic heart valves
7. Epilepsy or any other type of seizure history
8. History of significant head trauma (i.e., extended loss of consciousness, neurological sequelae)
9. Significant other disease (heart disease, malignant tumors, mental disorders)
10. Significant claustrophobia
11. Ménière's disease
12. Medications that increase risk of seizures, for instance antipsychotic and antidepressant medications acting primarily on the central nervous system, which lower the seizure threshold such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressants
13. Non-prescribed drug use, for instance recreational marijuana
14. Unable to refrain from using any alcohol and nicotine products for at least 24 hours before the study Visits.
18 Years
ALL
No
Sponsors
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Shirley Ryan AbilityLab
OTHER
Responsible Party
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Julio C Hernandez Pavon
Research Scientist
Principal Investigators
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Julio Hernandez Pavon, PhD
Role: PRINCIPAL_INVESTIGATOR
Shirley Ryan AbilityLab
Locations
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Shirley Ryan AbilityLab
Chicago, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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Julio Hernandez Pavon, PhD
Role: primary
Laura Kinsey, MS, CCC-SLP
Role: backup
Other Identifiers
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STU00217734
Identifier Type: -
Identifier Source: org_study_id