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Recruiting NCT06974279

Post-Stroke Aphasia TMS

No phase Interventional Aphasia Stroke Language

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Precision TMS with SFA, Control TMS with SFA.
Who it may be relevant to
Registry conditions: Aphasia, Stroke, Language. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Precision Neuromodulation in Post-Stroke Aphasia Using TMS

Overview

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).

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.

Interventions

  • Device Precision TMS with SFA
    Excitatory TMS delivered using a precision site finding approach and intermittent theta burst stimulation protocol
  • Device Control TMS with SFA
    Excitatory TMS using intermittent theta burst stimulation delivered to a control vertex site.

Primary outcome measures

  • Accuracy on a picture naming test [Time frame: immediately after and 8-12 weeks after last SFA+TMS treatment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Medical College of Wisconsin — Milwaukee

Publications

  • 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).
  • Esteban, O., Blair, R., Markiewicz, C. J., Berleant, S. L., Moodie, C., Ma, F., Isik, A. I., Erramuzpe, A., Goncalves, M., Poldrack, R. A., & Gorgolewski, K. J. (2017). poldracklab/fmriprep: 1.0.0-rc5 (1.0.0-rc5). Zenodo. https://doi.org/10.5281/zenodo.996169
  • Hallett M. Transcranial magnetic stimulation: a primer. Neuron. 2007 Jul 19;55(2):187-99. doi: 10.1016/j.neuron.2007.06.026. PMID 17640522
  • Griffis JC, Nenert R, Allendorfer JB, Szaflarski JP. Interhemispheric Plasticity following Intermittent Theta Burst Stimulation in Chronic Poststroke Aphasia. Neural Plast. 2016;2016:4796906. doi: 10.1155/2016/4796906. Epub 2016 Jan 10. PMID 26881111
  • Rossi S, Hallett M, Rossini PM, Pascual-Leone A. Screening questionnaire before TMS: an update. Clin Neurophysiol. 2011 Aug;122(8):1686. doi: 10.1016/j.clinph.2010.12.037. Epub 2011 Jan 11. No abstract available. PMID 21227747
  • Keel JC, Smith MJ, Wassermann EM. A safety screening questionnaire for transcranial magnetic stimulation. Clin Neurophysiol. 2001 Apr;112(4):720. doi: 10.1016/s1388-2457(00)00518-6. No abstract available. PMID 11332408
  • Wassermann EM. Risk and safety of repetitive transcranial magnetic stimulation: report and suggested guidelines from the International Workshop on the Safety of Repetitive Transcranial Magnetic Stimulation, June 5-7, 1996. Electroencephalogr Clin Neurophysiol. 1998 Jan;108(1):1-16. doi: 10.1016/s0168-5597(97)00096-8. PMID 9474057
  • Oberman L, Edwards D, Eldaief M, Pascual-Leone A. Safety of theta burst transcranial magnetic stimulation: a systematic review of the literature. J Clin Neurophysiol. 2011 Feb;28(1):67-74. doi: 10.1097/WNP.0b013e318205135f. PMID 21221011

Identifiers

NCT: NCT06974279 · PRO00053951

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗