Status:
COMPLETED
TMS in Aphasia Recovery
Lead Sponsor:
University of Pennsylvania
Conditions:
Aphasia
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Stroke often causes substantial problems in speaking or understanding speech. Treatments for these problems are currently very limited. Limited studies to date suggest that repetitive Transcranial Mag...
Eligibility Criteria
Inclusion
- Aphasic patients will have had single, unilateral left hemisphere ischemic stroke, which spared the supplementary motor area (SMA)
- With the exception of lacunar infarcts less than ≤ 1.5 cm (as measured by neuroimaging), the stroke causing the patients' impairments must be the only stroke.
- Aphasic patients will be at least 6 months post-stroke and have mild-severe, non-fluent speech
- Participants must be able to understand the nature of the study, and give informed consent
Exclusion
- Patients with more than one stroke
- Primary hemorrhagic stroke. Note: It is recognized that some ischemic strokes may have a minor amount of hemosiderin in the parenchyma. If this occurs, this is not considered a "hemorrhagic stroke" referred to in this exclusion criterion.
- Intracranial metallic bodies from prior neurosurgical procedure
- Signs of increased intracranial pressure as assessed by ophthalmic exam and patient symptoms
- Implanted pacemaker, medication pump, vagal nerve stimulator, deep brain stimulator, TENS unit or ventriculoperitoneal shunt
- History of seizure or unexplained loss of consciousness during the year prior to the initiation of the study
- Pregnancy. If the patient cannot rule out pregnancy then a pregnancy test will be conducted prior to inclusion into the study
- Family history of epilepsy
- Acute, unstable medical conditions
- History of substance abuse within the last 6 months
- Abnormal neurologic exam other than as signs of the condition studied in the present protocol
- History of known structural brain abnormality other than as signs of the condition studied in the present protocol
- History of tinnitus
- History of bipolar disorder
- Consumption of medicines known to lower the seizure threshold
- History of head injury with unconsciousness lasting more than 5 minutes
- Previous brain surgery
- Other medical or neurologic conditions, aside from stroke, in which the likelihood of developing a seizure is known to be increased
- Other medical or neurologic conditions, in which a seizure would be particularly harmful
- Significant cardiac disease
- Intracardiac lines of any type
- Current serious or unstable medical illness, including renal, hepatic, cardiovascular, gastrointestinal, endocrinologic, neurologic, immunologic, or hematological disease, that could require admission to a hospital within 3 months, or that death is anticipated within 3 years, or that requires daily supervision by a health professional
- Administration of any investigational drug within 5 half-lives of the drug prior to testing
Key Trial Info
Start Date :
June 26 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04777214
Start Date
June 26 2007
End Date
August 30 2011
Last Update
November 26 2021
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104