Language Processing and TMS

Stroke Clinical Trial

Official title:

Probing Language Processes Using Transcranial Magnetic Stimulation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05425615
• Other study ID #: 43228
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: June 2032

Study information

• Verified date: March 2024
• Source: Medical College of Wisconsin
• Contact: Sidney Schoenrock
• Phone: 414-955-7579
• Email: sschoenrock[@]mcw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 135
• Est. completion date: June 2032
• Est. primary completion date: June 2032
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Aphasia
• Language
• Stroke

Intervention

Device:
• Transcranial Magnetic Stimulation
Deymed DuoMag XT-35 rTMS

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

References & Publications (22)

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. — View Citation

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. — View Citation

Epstein CM. Transcranial magnetic stimulation: language function. J Clin Neurophysiol. 1998 Jul;15(4):325-32. doi: 10.1097/00004691-199807000-00004. — View Citation

Hallett M. Transcranial magnetic stimulation: a primer. Neuron. 2007 Jul 19;55(2):187-99. doi: 10.1016/j.neuron.2007.06.026. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Lerner AJ, Wassermann EM, Tamir DI. Seizures from transcranial magnetic stimulation 2012-2016: Results of a survey of active laboratories and clinics. Clin Neurophysiol. 2019 Aug;130(8):1409-1416. doi: 10.1016/j.clinph.2019.03.016. Epub 2019 Apr 6. — View Citation

Narayana S, Gibbs SK, Fulton SP, McGregor AL, Mudigoudar B, Weatherspoon SE, Boop FA, Wheless JW. Clinical Utility of Transcranial Magnetic Stimulation (TMS) in the Presurgical Evaluation of Motor, Speech, and Language Functions in Young Children With Refractory Epilepsy or Brain Tumor: Preliminary Evidence. Front Neurol. 2021 May 19;12:650830. doi: 10.3389/fneur.2021.650830. eCollection 2021. — View Citation

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. — View Citation

Pascual-Leone A, Bartres-Faz D, Keenan JP. Transcranial magnetic stimulation: studying the brain-behaviour relationship by induction of 'virtual lesions'. Philos Trans R Soc Lond B Biol Sci. 1999 Jul 29;354(1387):1229-38. doi: 10.1098/rstb.1999.0476. — View Citation

Pascual-Leone A, Walsh V, Rothwell J. Transcranial magnetic stimulation in cognitive neuroscience--virtual lesion, chronometry, and functional connectivity. Curr Opin Neurobiol. 2000 Apr;10(2):232-7. doi: 10.1016/s0959-4388(00)00081-7. — View Citation

Rossi S, Antal A, Bestmann S, Bikson M, Brewer C, Brockmoller J, Carpenter LL, Cincotta M, Chen R, Daskalakis JD, Di Lazzaro V, Fox MD, George MS, Gilbert D, Kimiskidis VK, Koch G, Ilmoniemi RJ, Lefaucheur JP, Leocani L, Lisanby SH, Miniussi C, Padberg F, Pascual-Leone A, Paulus W, Peterchev AV, Quartarone A, Rotenberg A, Rothwell J, Rossini PM, Santarnecchi E, Shafi MM, Siebner HR, Ugawa Y, Wassermann EM, Zangen A, Ziemann U, Hallett M; basis of this article began with a Consensus Statement from the IFCN Workshop on "Present, Future of TMS: Safety, Ethical Guidelines", Siena, October 17-20, 2018, updating through April 2020. Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines. Clin Neurophysiol. 2021 Jan;132(1):269-306. doi: 10.1016/j.clinph.2020.10.003. Epub 2020 Oct 24. — View Citation

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. — View Citation

Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14. — View Citation

Rossini PM, Burke D, Chen R, Cohen LG, Daskalakis Z, Di Iorio R, Di Lazzaro V, Ferreri F, Fitzgerald PB, George MS, Hallett M, Lefaucheur JP, Langguth B, Matsumoto H, Miniussi C, Nitsche MA, Pascual-Leone A, Paulus W, Rossi S, Rothwell JC, Siebner HR, Ugawa Y, Walsh V, Ziemann U. Non-invasive electrical and magnetic stimulation of the brain, spinal cord, roots and peripheral nerves: Basic principles and procedures for routine clinical and research application. An updated report from an I.F.C.N. Committee. Clin Neurophysiol. 2015 Jun;126(6):1071-1107. doi: 10.1016/j.clinph.2015.02.001. Epub 2015 Feb 10. — View Citation

Rossini PM, Rossi S. Clinical applications of motor evoked potentials. Electroencephalogr Clin Neurophysiol. 1998 Mar;106(3):180-94. doi: 10.1016/s0013-4694(97)00097-7. — View Citation

Shrout PE, Rodgers JL. Psychology, Science, and Knowledge Construction: Broadening Perspectives from the Replication Crisis. Annu Rev Psychol. 2018 Jan 4;69:487-510. doi: 10.1146/annurev-psych-122216-011845. — View Citation

Walsh V, Cowey A. Transcranial magnetic stimulation and cognitive neuroscience. Nat Rev Neurosci. 2000 Oct;1(1):73-9. doi: 10.1038/35036239. — View Citation

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. — View Citation

Wilson SM, Eriksson DK, Schneck SM, Lucanie JM. A quick aphasia battery for efficient, reliable, and multidimensional assessment of language function. PLoS One. 2018 Feb 9;13(2):e0192773. doi: 10.1371/journal.pone.0192773. eCollection 2018. Erratum In: PLoS One. 2018 Jun 15;13(6):e0199469. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reaction time on language task performance	Improvement on language task performance as measured by decrease in reaction time.	Language tasks administered immediately before and/or after TMS administration (same day).
Primary	Accuracy on language task performance	Improvement on language task performance as measured by increase in accuracy.	Language tasks administered immediately before and/or after TMS administration (same day).