Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
50 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-09-01
Study Completion Date
2036-12-31
Brief Summary
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The investigator proposes to examine the effects of excitatory transcranial magnetic stimulation (TMS) combined with semantic feature analysis (SFA) language therapy to improve word-finding abilities in stroke survivors with aphasia (SWA).
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Detailed Description
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In this project, the investigator will use functional neuroimaging and inhibitory TMS to determine precise therapy-responsive targets for excitatory TMS therapy with SFA. One group of stroke survivors will receive SFA + TMS targeting the precision site, and another group will receive SFA + TMS targeting a control site. The primary outcome will be changes in picture naming accuracy. We expect that excitatory TMS targeting a precision site would result in larger improvements in naming accuracy than TMS targeting a control site. Results will provide the efficacy of precision TMS in post-stroke aphasia.
Conditions
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Aphasia
Stroke
Language
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Participants
Study Groups
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Precision TMS
SFA will be administered immediately after precision TMS
Group Type
ACTIVE_COMPARATOR
Precision TMS with SFA
Intervention Type
DEVICE
Excitatory TMS delivered using a precision site finding approach and intermittent theta burst stimulation protocol
Control TMS
SFA will be administered immediately after control TMS
Group Type
PLACEBO_COMPARATOR
Control TMS with SFA
Intervention Type
DEVICE
Excitatory TMS using intermittent theta burst stimulation delivered to a control vertex site.
Interventions
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Precision TMS with SFA
Excitatory TMS delivered using a precision site finding approach and intermittent theta burst stimulation protocol
Intervention Type
DEVICE
Control TMS with SFA
Excitatory TMS using intermittent theta burst stimulation delivered to a control vertex site.
Intervention Type
DEVICE
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with left hemisphere stroke
* Consent date \>= 1 month after stroke onset
* Fluent in English
* 18 years of age or older
* Consent date \>= 1 month after stroke onset
* Fluent in English
* 18 years of age or older
Exclusion Criteria
* Severe cognitive, auditory or visual impairments that would preclude cognitive and language testing
* Presence of major untreated or unstable psychiatric disease (e.g. schizophrenia, bipolar disease)
* A chronic medical condition that is not treated or is unstable
* The presence of cardiac stimulators or pacemakers or intracardiac lines, neurostimulators, medication infusion device, any other implants near the scalp (e.g., cochlear implants) or in the eye, metal in the body (e.g., splinters, fragments, clips)
* Pregnancy
* History of skull fractures, or skin diseases
* History of ongoing or unmanaged seizures
* Presence of factors that potentially decrease seizure thresholds: on pro-convulsant medications, untreated sleep deprivation or insomnia, ongoing alcoholism or illegal drug abuse (e.g., cocaine or MDMA users)
* History of dyslexia or other developmental learning disabilities
* Presence of major untreated or unstable psychiatric disease (e.g. schizophrenia, bipolar disease)
* A chronic medical condition that is not treated or is unstable
* The presence of cardiac stimulators or pacemakers or intracardiac lines, neurostimulators, medication infusion device, any other implants near the scalp (e.g., cochlear implants) or in the eye, metal in the body (e.g., splinters, fragments, clips)
* Pregnancy
* History of skull fractures, or skin diseases
* History of ongoing or unmanaged seizures
* Presence of factors that potentially decrease seizure thresholds: on pro-convulsant medications, untreated sleep deprivation or insomnia, ongoing alcoholism or illegal drug abuse (e.g., cocaine or MDMA users)
* History of dyslexia or other developmental learning disabilities
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Medical College of Wisconsin
OTHER
Sponsor Role
lead
Responsible Party
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Priyanka Shah-Basak, PhD
Assistant Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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References
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Patrício, Brígida F, Luis M. T. Jesus and Madeline N. Cruice. "Quality of life of the caregivers of people with aphasia. A systematic review." (2013).
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Lefaucheur JP, Aleman A, Baeken C, Benninger DH, Brunelin J, Di Lazzaro V, Filipovic SR, Grefkes C, Hasan A, Hummel FC, Jaaskelainen SK, Langguth B, Leocani L, Londero A, Nardone R, Nguyen JP, Nyffeler T, Oliveira-Maia AJ, Oliviero A, Padberg F, Palm U, Paulus W, Poulet E, Quartarone A, Rachid F, Rektorova I, Rossi S, Sahlsten H, Schecklmann M, Szekely D, Ziemann U. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014-2018). Clin Neurophysiol. 2020 Feb;131(2):474-528. doi: 10.1016/j.clinph.2019.11.002. Epub 2020 Jan 1.
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Shah-Basak PP, Wurzman R, Purcell JB, Gervits F, Hamilton R. Fields or flows? A comparative metaanalysis of transcranial magnetic and direct current stimulation to treat post-stroke aphasia. Restor Neurol Neurosci. 2016 May 2;34(4):537-58. doi: 10.3233/RNN-150616.
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Norise C, Hamilton RH. Non-invasive Brain Stimulation in the Treatment of Post-stroke and Neurodegenerative Aphasia: Parallels, Differences, and Lessons Learned. Front Hum Neurosci. 2017 Jan 23;10:675. doi: 10.3389/fnhum.2016.00675. eCollection 2016.
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Kielar A, Patterson D, Chou YH. Efficacy of repetitive transcranial magnetic stimulation in treating stroke aphasia: Systematic review and meta-analysis. Clin Neurophysiol. 2022 Aug;140:196-227. doi: 10.1016/j.clinph.2022.04.017. Epub 2022 May 5.
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Chou TY, Wang JC, Lin MY, Tsai PY. Low-Frequency vs. Theta Burst Transcranial Magnetic Stimulation for the Treatment of Chronic Non-fluent Aphasia in Stroke: A Proof-of-Concept Study. Front Aging Neurosci. 2022 Jan 14;13:800377. doi: 10.3389/fnagi.2021.800377. eCollection 2021.
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Shah-Basak PP, Norise C, Garcia G, Torres J, Faseyitan O, Hamilton RH. Individualized treatment with transcranial direct current stimulation in patients with chronic non-fluent aphasia due to stroke. Front Hum Neurosci. 2015 Apr 21;9:201. doi: 10.3389/fnhum.2015.00201. eCollection 2015.
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Szaflarski JP, Griffis J, Vannest J, Allendorfer JB, Nenert R, Amara AW, Sung V, Walker HC, Martin AN, Mark VW, Zhou X. A feasibility study of combined intermittent theta burst stimulation and modified constraint-induced aphasia therapy in chronic post-stroke aphasia. Restor Neurol Neurosci. 2018;36(4):503-518. doi: 10.3233/RNN-180812.
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Szaflarski JP, Vannest J, Wu SW, DiFrancesco MW, Banks C, Gilbert DL. Excitatory repetitive transcranial magnetic stimulation induces improvements in chronic post-stroke aphasia. Med Sci Monit. 2011 Feb 25;17(3):CR132-9. doi: 10.12659/msm.881446.
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Shah-Basak P, Boukrina O, Li XR, Jebahi F, Kielar A. Targeted neurorehabilitation strategies in post-stroke aphasia. Restor Neurol Neurosci. 2023;41(3-4):129-191. doi: 10.3233/RNN-231344.
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Other Identifiers
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PRO00053951
Identifier Type: -
Identifier Source: org_study_id
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