Effects of rTMS on Brain Activation in Aphasia
Immediate and Cumulative Effects of rTMS on Brain Activation in Chronic Aphasia
2 other identifiers
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2017
CompletedFirst Posted
Study publicly available on registry
September 25, 2017
CompletedStudy Start
First participant enrolled
January 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedResults Posted
Study results publicly available
January 21, 2022
CompletedDecember 20, 2022
December 1, 2022
2 years
September 8, 2017
September 20, 2021
December 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Philadelphia Naming Test (PNT) Performance
The Philadelphia Naming Test is a performance-based measure commonly used to assess naming (word production) ability among adults with aphasia. The minimum raw score is 0 and the maximum is 175 (higher scores reflect more accurate naming/better naming ability).
Pre- to post treatment (an average of 3 weeks), and at 2 month follow-up
Secondary Outcomes (1)
Change in Comprehensive Aphasia Test (CAT) Performance
Pre- to post treatment (an average of 3 weeks), and at 2 month follow-up
Study Arms (2)
Inhibitory only
EXPERIMENTALInhibitory 1Hz rTMS will be applied continuously for 1200 pulses (20 minutes) 5 days per week across 2 weeks (10 sessions total).
Excitatory primed
EXPERIMENTALThe 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).
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Unable to collect all planned functional MRI data due to technical difficulties/scanner out of service.
Results Point of Contact
- Title
- Dr. Michelle Gravier
- Organization
- VA Pittsburgh/California State University, East Bay
Study Officials
- PRINCIPAL INVESTIGATOR
Michelle L. Gravier, PhD
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2017
First Posted
September 25, 2017
Study Start
January 1, 2018
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
December 20, 2022
Results First Posted
January 21, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share