Precision Neuromodulation in Post-Stroke Aphasia Using TMS
| Registry | NCT06974279, acronym TaMS |
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| Status | Recruiting |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, parallel, masking: single, treatment |
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| Enrollment | 50 (Estimated) |
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| Sponsor | Medical College of Wisconsin (Other) |
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| Conditions | Aphasia, Stroke, Language |
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| Interventions | Precision TMS with SFA, Control TMS with SFA (Device) |
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| Dates | start 2025-09-01, primary completion 2036-12-31 (estimated), completion 2036-12-31 (estimated), first posted 2025-05-15, last updated 2026-07-10 |
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| Locations | 1 site in United States |
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Related Papers Related Patents Related Grants Related Experts
All trials for Aphasia All trials for Stroke All trials of Precision TMS with SFA All trials of Control TMS with SFA
-Summary
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
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.
+Arms and interventions
| Arm | Type | Interventions | Description |
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| Precision TMS | Active comparator | Device: Precision TMS with SFA | SFA will be administered immediately after precision TMS |
| Control TMS | Placebo comparator | Device: Control TMS with SFA | SFA will be administered immediately after control TMS |
- Precision TMS with SFA (Device): Excitatory TMS delivered using a precision site finding approach and intermittent theta burst stimulation protocol
- Control TMS with SFA (Device): Excitatory TMS using intermittent theta burst stimulation delivered to a control vertex site.
+Outcome measures
Primary outcomes
- Accuracy on a picture naming test [immediately after and 8-12 weeks after last SFA+TMS treatment]: Changes in accuracy on untrained stimuli after SFA+TMS compared between groups (precision, control).
+Eligibility
Sex: All, ages: 18 Years to any
Inclusion Criteria:
* Diagnosed with left hemisphere stroke
* 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
+Locations (1)
| Facility | City | Country | Status |
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| Medical College of Wisconsin | Milwaukee, Wisconsin | United States | Recruiting |
+Publications
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