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Effects of rTMS on Brain Activation in Aphasia

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ClinicalTrials.gov Identifier: NCT03292471
Recruitment Status : Recruiting
First Posted : September 25, 2017
Last Update Posted : July 10, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
This study will investigate the use of repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation method, to improve word-finding abilities in Veterans and non-Veterans with chronic language problems following stroke (aphasia). Improving word-finding is important because word-finding difficulties are among the most common and debilitating consequences of aphasia. Although rTMS has shown promise as a treatment approach, not all individuals with aphasia show the same level of benefit. Specifically, this study will use functional magnetic resonance imaging (fMRI) to examine whether the likelihood of improved word-finding abilities following rTMS depends on pre-intervention language-related brain activity and will examine changes in brain activity in response to stimulation. A better understanding of how and for whom rTMS works will 1) help to identify the best candidates for rTMS treatment, 2) optimize rTMS treatment protocols to improve patient outcomes, and 3) improve the investigators' understanding of how the brain re-organizes language functions following stroke.

Condition or disease Intervention/treatment Phase
Aphasia, Acquired Device: Transcranial Magnetic Stimulation Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be assigned to receive 10 sessions of inhibitory rTMS to right hemisphere pars triangularis (RH PTr), either preceded by a 6 Hz priming rTMS stimulation sequence or not.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Immediate and Cumulative Effects of rTMS on Brain Activation in Chronic Aphasia
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia

Arm Intervention/treatment
Experimental: Inhibitory only
Inhibitory 1Hz rTMS will be applied continuously for 1200 pulses (20 minutes) 5 days per week across 2 weeks (10 sessions total).
Device: Transcranial Magnetic Stimulation
rTMS is a non-invasive brain stimulation technique in which a focal, time-varying magnetic field is applied to a specific brain area to induce neuronal depolarization. rTMS can be used to selectively target a given brain region with a resolution as focal as 0.5 cm3 .Typically, administering a slow (1 Hz) sequence of magnetic pulses via rTMS temporarily reduces cortical excitability in the targeted brain region.
Other Name: rTMS

Experimental: Excitatory primed
The inhibitory sequence described above will be preceded for each session by priming stimulation which will consist of intermittent 6-Hz rTMS applied in 5 second trains with 25 second intervals between trains for a total 600 pulses (10 minutes).
Device: Transcranial Magnetic Stimulation
rTMS is a non-invasive brain stimulation technique in which a focal, time-varying magnetic field is applied to a specific brain area to induce neuronal depolarization. rTMS can be used to selectively target a given brain region with a resolution as focal as 0.5 cm3 .Typically, administering a slow (1 Hz) sequence of magnetic pulses via rTMS temporarily reduces cortical excitability in the targeted brain region.
Other Name: rTMS




Primary Outcome Measures :
  1. Change in Philadelphia Naming Test (PNT) performance [ Time Frame: Pre- to post treatment (an average of 3 weeks), and at 2 month follow-up ]
    The Philadelphia Naming Test is a performance-based measure commonly used to assess naming (word production) ability among adults with aphasia.


Secondary Outcome Measures :
  1. Change in Naming-related functional brain activation [ Time Frame: Pre- to post treatment (an average of 3 weeks), and at 2 month follow-up ]
    Participants will be asked to name pictures aloud while in the MRI scanner.

  2. Change in Comprehensive Aphasia Test (CAT) performance [ Time Frame: Pre- to post treatment (an average of 3 weeks), and at 2 month follow-up ]
    The Comprehensive Aphasia Test is a performance-based measure of language processing across multiple language domains commonly used to assess language-processing ability among adults with aphasia.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aphasia due to unilateral left-hemisphere stroke
  • Greater than 6 months post aphasia onset
  • English as a first language
  • No contraindications to MRI or TMS including:

    • pregnancy
    • presence of ferromagnetic substances in the head with the exception of dental fillings, stents or aneurysm clips documented to be MRI compatible
    • presence of any implanted devices including cardiac pacemaker, implanted cardiac defibrillator, insulin pump, cochlear implant, or drug infusion device
    • history of epilepsy; use of medications that are known to lower seizure threshold
    • severe claustrophobia

Exclusion Criteria:

  • History for progressive neurological disease or premorbid language disorder
  • Presence of severe motor speech disorder
  • Drug or alcohol dependence, or significant mood or behavioral disorder that is not currently stable or medically managed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03292471


Contacts
Contact: Michelle L Gravier, PhD (412) 360-6486 michelle.gravier@va.gov
Contact: Michael W Dickey, PhD (412) 954-4767 Michael.Dickey@va.gov

Locations
United States, Pennsylvania
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA Recruiting
Pittsburgh, Pennsylvania, United States, 15240
Contact: Mary Sullivan, BA    412-360-6472    Mary.Sullivan@va.gov   
Principal Investigator: Michelle L. Gravier, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Michelle L. Gravier, PhD VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03292471     History of Changes
Other Study ID Numbers: B2566-P
I21RX002566-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
Aphasia
Rehabilitation
Stroke

Additional relevant MeSH terms:
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms