Back to resultsTMS in Aphasia Recovery
Primary Purpose
Aphasia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation
Sham TMS
Sponsored by
About this trial
This is an interventional treatment trial for Aphasia
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
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Active TMS
Sham TMS
Arm Description
There are 10 TMS sessions over 2 consecutive weeks in which 20 minutes (1200 pulses) of 1 Hz active TMS are delivered to a previously determined optimal response site in right frontal lobe.
There are 10 TMS sessions over 2 consecutive weeks in which 20 minutes (1200 pulses) of 1 Hz TMS are delivered, however, the coil will be rotated 90 degrees during stimulation.
Outcomes
Primary Outcome Measures
Boston Naming Test
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT04777214
First Posted
February 2, 2021
Last Updated
October 27, 2021
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT04777214
Brief Title
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
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
June 26, 2007 (Actual)
Primary Completion Date
August 30, 2011 (Actual)
Study Completion Date
August 30, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare Provider
Masking Description
The procedure for localizing the site of stimulation and TMS administration will be identical to the treatment arm, except the coil will be rotated 90 degrees during the process/administration.
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active TMS
Arm Type
Active Comparator
Arm Description
There are 10 TMS sessions over 2 consecutive weeks in which 20 minutes (1200 pulses) of 1 Hz active TMS are delivered to a previously determined optimal response site in right frontal lobe.
Arm Title
Sham TMS
Arm Type
Sham Comparator
Arm Description
There are 10 TMS sessions over 2 consecutive weeks in which 20 minutes (1200 pulses) of 1 Hz TMS are delivered, however, the coil will be rotated 90 degrees during stimulation.
Intervention Type
Device
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation
Intervention Description
Active TMS will be at 90% motor threshold
Intervention Type
Device
Intervention Name(s)
Sham TMS
Intervention Description
Sham TMS will be administered
Primary Outcome Measure Information:
Title
Boston Naming Test
Description
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)
Time Frame
Baseline, 2 months and 6-months after the last rTMS treatment session
Other Pre-specified Outcome Measures:
Title
Picture Description of the Boston Diagnostic Aphasia Exam
Description
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.
Time Frame
Baseline and 2 months after the last rTMS treatment session
Title
Boston Diagnostic Aphasia Exam - Word Discrimination Subtest
Description
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)
Time Frame
Baseline and 2 months after the last rTMS treatment session
Title
Boston Diagnostic Aphasia Examination - Commands Subtest
Description
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.
Time Frame
Baseline and 2 months after the last rTMS treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
H. Branch Coslett, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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TMS in Aphasia Recovery
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