Clinical trial NCT04777214: TMS in Aphasia Recovery
Official title: A Blinded Randomized Sham-Controlled Incomplete Crossover Trial of Low-Frequency Contralesional Repetitive Transcranial Magnetic Stimulation in the Treatment of Aphasia in Patients With Chronic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphasia
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2021-03-02
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study involves two arms. The study involves a sham treatment control for half of the patients; all patients randomized to the sham treatment will be enrolled in the treatment phase after completing the sham treatment. Patients will be randomly assigned to the treatment arm or the sham treatment arm of the study. There are 3 phases: a pre-treatment evaluation phase in which baseline language and imaging data are obtained and the optimal site for stimulation is determined; a treatment phase during which TMS is delivered on 10 occasions; and a post-treatment phase during which effects of the treatment will be assessed using behavioral measures as well as fMRI at 2 and 6-months. Participants in the sham arm will undergo the same behavioral testing, MRI, and fMRI that will be administered in the treatment protocol. After the 2-month follow up visit, patients in the sham arm will be told that they did not receive real TMS and will be offered the opportunity to enter the treatment arm.
Primary purpose: TREATMENT

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 Magnetic Stimulation (TMS) to the side of the brain opposite to the side on which the stroke occurred may improve language function. The investigators are testing this hypothesis by giving daily 20 minute sessions of repeated TMS to the right (unaffected) side of the brain; the investigators test language function with a variety of tests both before and after the treatment with TMS and subjects are required to undergo functional MRI scans before and after treatment. TMS is a procedure in which a coil is placed next to the head of the subject and an electrical current passes through the coil causing a magnetic field that, in turn, causes a small electric current in the portion of the brain underneath the coil.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Boston Naming Test
timeFrame: Baseline, 2 months and 6-months after the last rTMS treatment session
Secondary outcomes:
Other outcomes:
measure: Picture Description of the Boston Diagnostic Aphasia Exam
timeFrame: Baseline and 2 months after the last rTMS treatment session
measure: Boston Diagnostic Aphasia Exam - Word Discrimination Subtest
timeFrame: Baseline and 2 months after the last rTMS treatment session
measure: Boston Diagnostic Aphasia Examination - Commands Subtest
timeFrame: Baseline and 2 months after the last rTMS treatment
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: H. Branch Coslett, MD
role: PRINCIPAL_INVESTIGATOR
References: