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Recruiting NCT05425615

Language Processing and TMS

No phase Interventional Stroke Aphasia 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: Transcranial Magnetic Stimulation.
Who it may be relevant to
Registry conditions: Stroke, Aphasia, Language. Basic parameters: 18 years — 85 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

Probing Language Processes Using Transcranial Magnetic Stimulation

Overview

This study will examine the effect of TMS on people with stroke and aphasia as well as healthy individuals.

Detailed description

To examine the brain's structure and specific language function and interactive relationships, investigators will implement repetitive or rapid TMS protocols in an active (or sham)-controlled, within-subject, randomized studies. Aims will evaluate the effects of short-term changes on each of the semantic or phonological language process of interest in isolation and changes in the interaction between language sub-processes and their interaction with other cognitive domains that directly or indirectly affect language functions. The brain targets for TMS application will be informed by existing evidence on (correlational but not causal) associations between language regions and specific language processes from numerous prior neuroimaging (e.g., functional magnetic resonance imaging or fMRI) and neuropsychological studies. Healthy individuals and/or stroke survivors with aphasia will be recruited to address these aims.

Interventions

  • Device Transcranial Magnetic Stimulation
    Deymed DuoMag XT-100 rTMS

Primary outcome measures

  • Reaction time on language task performance [Time frame: Language tasks administered immediately before and/or after TMS administration (same day).]
  • Accuracy on language task performance [Time frame: Language tasks administered immediately before and/or after TMS administration (same day).]

Eligibility criteria

Inclusion criteria

  • Diagnosed with left hemisphere stroke
  • Consent date >= 1 month after stroke onset
  • Right-handed
  • Fluent in English
  • 18 years of age or older

Exclusion criteria

  • Severe cognitive, auditory or visual impairments that would preclude cognitive and language testing
  • Non-decisional per decisionality questionnaire or other clinical assessment
  • Presence of major untreated or unstable psychiatric disease (e.g. schizophrenia, bipolar disease)
  • A chronic medical condition that is not treated or is unstable
  • 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
  • Pregnancy
  • History of skull fractures, or skin diseases
  • History of ongoing or unmanaged seizures or a family history of epilepsy
  • 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: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Basic science

Study locations

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

Publications

  • Chen R, Classen J, Gerloff C, Celnik P, Wassermann EM, Hallett M, Cohen LG. Depression of motor cortex excitability by low-frequency transcranial magnetic stimulation. Neurology. 1997 May;48(5):1398-403. doi: 10.1212/wnl.48.5.1398. PMID 9153480
  • Devlin JT, Watkins KE. Stimulating language: insights from TMS. Brain. 2007 Mar;130(Pt 3):610-22. doi: 10.1093/brain/awl331. Epub 2006 Nov 29. PMID 17138570
  • Epstein CM. Transcranial magnetic stimulation: language function. J Clin Neurophysiol. 1998 Jul;15(4):325-32. doi: 10.1097/00004691-199807000-00004. PMID 9736466
  • 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
  • Hamilton RH, Chrysikou EG, Coslett B. Mechanisms of aphasia recovery after stroke and the role of noninvasive brain stimulation. Brain Lang. 2011 Jul;118(1-2):40-50. doi: 10.1016/j.bandl.2011.02.005. Epub 2011 Apr 2. PMID 21459427
  • Huang YZ, Edwards MJ, Rounis E, Bhatia KP, Rothwell JC. Theta burst stimulation of the human motor cortex. Neuron. 2005 Jan 20;45(2):201-6. doi: 10.1016/j.neuron.2004.12.033. PMID 15664172
  • 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
  • Lehtinen H, Makela JP, Makela T, Lioumis P, Metsahonkala L, Hokkanen L, Wilenius J, Gaily E. Language mapping with navigated transcranial magnetic stimulation in pediatric and adult patients undergoing epilepsy surgery: Comparison with extraoperative direct cortical stimulation. Epilepsia Open. 2018 Apr 6;3(2):224-235. doi: 10.1002/epi4.12110. eCollection 2018 Jun. PMID 29881801

Identifiers

NCT: NCT05425615 · 43228

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗