Clinical trial NCT05425615: Language Processing and TMS
Official title: Probing Language Processes Using Transcranial Magnetic Stimulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Aphasia
Language
Keywords: TMS
Transcranial Magnetic Stimulation
Aphasia
Semantic processing
Phonological processing
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multiple studies will be conducted in parallel. But within a study, the interventional assignment will be set to cross-over with 3-4 arms.
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

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

  1. cardiac stimulators or pacemakers or intracardiac lines
  2. neurostimulators
  3. medication infusion device
  4. any other implants near the scalp (e.g., cochlear implants) or in the eye
  5. 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

Primary outcomes:
measure: Reaction time on language task performance
timeFrame: Language tasks administered immediately before and/or after TMS administration (same day).
measure: Accuracy on language task performance
timeFrame: Language tasks administered immediately before and/or after TMS administration (same day).
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Priyanka Shah-Basak, PhD
role: PRINCIPAL_INVESTIGATOR
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