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TMS in Aphasia Recovery

NCT ID: NCT04777214

Last Updated: 2021-11-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-26

Study Completion Date

2011-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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Aphasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
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.

Study Groups

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Active TMS

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.

Group Type ACTIVE_COMPARATOR

Repetitive Transcranial Magnetic Stimulation

Intervention Type DEVICE

Active TMS will be at 90% motor threshold

Sham TMS

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.

Group Type SHAM_COMPARATOR

Sham TMS

Intervention Type DEVICE

Sham TMS will be administered

Interventions

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Repetitive Transcranial Magnetic Stimulation

Active TMS will be at 90% motor threshold

Intervention Type DEVICE

Sham TMS

Sham TMS will be administered

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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H. Branch Coslett

Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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H. Branch Coslett, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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805362

Identifier Type: -

Identifier Source: org_study_id