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Completed

NCT Number: NCT04777214

TMS in Aphasia Recovery

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

repetitive transcranial magnetic stimulation

Device

Active TMS will be at 90% motor threshold

Sham TMS

Device

Sham TMS will be administered

Primary outcomes

  1. Boston Naming Test

    Time frame: Baseline, 2 months and 6-months after the last rTMS treatment session

    The Boston Naming Test is an assessment of confrontation naming, where a score ranges from 0 (no items named correctly) to 36 (all items named correctly)

Other outcomes

  1. Picture Description of the Boston Diagnostic Aphasia Exam

    Time frame: Baseline and 2 months after the last rTMS treatment session

    The picture description of the Boston Diagnostic Aphasia Exam is a measurement of spontaneous speech, elicited by a picture description. It is not a scale. Quantitative Production Analysis (QPA) is used to analyze the production of words related to the picture stimulus. Total number of Narrative Words produced, defined as total words minus stereotyped utterances, task-related comments, or comments cued by administrator, was determined using QPA as a measure of discourse productivity.

  2. Boston Diagnostic Aphasia Exam - Word Discrimination Subtest

    Time frame: Baseline and 2 months after the last rTMS treatment session

    The Boston Diagnostic Aphasia Exam - Word Discrimination Subtest is an assessment of auditory comprehension via word discrimination, where a score ranges from 0 (no items correct) to 72 (all items correct)

  3. Boston Diagnostic Aphasia Examination - Commands Subtest

    Time frame: Baseline and 2 months after the last rTMS treatment

    The Boston Diagnostic Aphasia Examination - Commands Subtest is an assessment of auditory comprehension via command following, where a score ranges from 0 (no items correctly performed) to 15 (all items correctly performed). Percent change was calculated by taking the mean performance at 2-months after rTMS treatment and subtracting mean performance at baseline, then dividing by the mean baseline performance and multiplying by 100.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Mar 2, 2021
Registry last updated
Nov 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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