Study Results
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Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2023-10-03
2033-01-01
Brief Summary
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Detailed Description
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This study will examine the effects of tDCS during speech therapy to further examine which method or methods is best for patient recovery. Patients enrolled in the study will undergo language testing that covers a broad range of language functions. Functional Magnetic Resonance Imaging (fMRI) will be completed before and after speech therapy intervention arms to investigate the neural processes affected by tDCS and speech therapy.
Study design:
Patients will be randomly assigned to one of 2 speech therapy groups as well as randomly assigned to one of 2 stimulation groups (active anodal stimulation or sham). Patients will receive one of two different speech therapy treatment interventions to focus on specific processing deficits. Participants will undergo neuropsychological evaluation and fMRI assessment before receiving targeted anodal-tDCS or sham-tDCS for 10 therapy sessions. Participants will then be re-tested using the behavioral assessment measure and fMRI before crossing over to receive the tDCS intervention again, along with the same speech therapy arm. They will complete a behavioral assessment and fMRI at 3 months post Treatment 2 and a final behavioral assessment at 6 months post Treatment 2.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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HD-tDCS
Participants will be randomized to receive either anodal HD-tDCS or sham-tDCS.
Targeted Transcranial Direct Current Stimulation
High-Definition-tDCS will be delivered via a battery-driven constant direct current stimulator (Soterix) using a 4x1 montage (1 central anodal electrode and 4 cathodal electrodes) arranged in a HD-cap. Anodal or sham tDCS will be administered.
Speech Therapy
Participants will be randomized to receive either phonologic-focused speech therapy or semantic-focused speech therapy
Speech Therapy
Participants will receive either semantic or phonological focused speech therapy
Interventions
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Targeted Transcranial Direct Current Stimulation
High-Definition-tDCS will be delivered via a battery-driven constant direct current stimulator (Soterix) using a 4x1 montage (1 central anodal electrode and 4 cathodal electrodes) arranged in a HD-cap. Anodal or sham tDCS will be administered.
Speech Therapy
Participants will receive either semantic or phonological focused speech therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Patients may not be older than 85.
Patients must have a language deficit from left-sided focal neurologic damage (e.g. stroke, tumor).
Patients must be adults and have English-language fluency.
Patients must be eligible to undergo MRI.
Exclusion Criteria
Neurologic disease (e.g. idiopathic epilepsy, seizure disorders that are not well managed, Parkinson's disease, ALS),
Severe psychopathology (e.g. schizophrenia, bipolar disorder, acute major depressive episode)
Suspected or diagnosed uncorrectable hearing or vision difficulties, or developmental disabilities (i.e. intellectual disability or learning disability).
Contraindications to MRI such as claustrophobia, implanted electronic devices, MRI-incompatible metal in the body, extreme obesity, pregnancy, inability to lie flat, inability to see or hear stimulus materials.
Younger than 18 or older than 85.
\< 6 months post tumor resection.
18 Years
85 Years
ALL
No
Sponsors
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Medical College of Wisconsin
OTHER
Responsible Party
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Priyanka Shah-Basak, PhD
Assistant Professor
Locations
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Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Sara Pillay, Ph.D
Role: backup
References
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Greener J, Enderby P, Whurr R. Pharmacological treatment for aphasia following stroke. Cochrane Database Syst Rev. 2001;2001(4):CD000424. doi: 10.1002/14651858.CD000424.
Kelly H, Brady MC, Enderby P. Speech and language therapy for aphasia following stroke. Cochrane Database Syst Rev. 2010 May 12;(5):CD000425. doi: 10.1002/14651858.CD000425.pub2.
Lincoln NB, McGuirk E, Mulley GP, Lendrem W, Jones AC, Mitchell JR. Effectiveness of speech therapy for aphasic stroke patients. A randomised controlled trial. Lancet. 1984 Jun 2;1(8388):1197-200. doi: 10.1016/s0140-6736(84)91690-8.
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Ellis C, Dismuke C, Edwards KK. Longitudinal trends in aphasia in the United States. NeuroRehabilitation. 2010;27(4):327-33. doi: 10.3233/NRE-2010-0616.
Boysen AE, Wertz RT. Clinician Costs in Aphasia Treatment: How Much Is a Word Worth? Clin. Aphasiology 1996;24:207-213
Meinzer M, Djundja D, Barthel G, Elbert T, Rockstroh B. Long-term stability of improved language functions in chronic aphasia after constraint-induced aphasia therapy. Stroke. 2005 Jul;36(7):1462-6. doi: 10.1161/01.STR.0000169941.29831.2a. Epub 2005 Jun 9.
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Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol. 2000 Sep 15;527 Pt 3(Pt 3):633-9. doi: 10.1111/j.1469-7793.2000.t01-1-00633.x.
Nitsche MA, Paulus W. Sustained excitability elevations induced by transcranial DC motor cortex stimulation in humans. Neurology. 2001 Nov 27;57(10):1899-901. doi: 10.1212/wnl.57.10.1899.
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Darkow R, Martin A, Wurtz A, Floel A, Meinzer M. Transcranial direct current stimulation effects on neural processing in post-stroke aphasia. Hum Brain Mapp. 2017 Mar;38(3):1518-1531. doi: 10.1002/hbm.23469. Epub 2016 Nov 11.
Meinzer M, Jahnigen S, Copland DA, Darkow R, Grittner U, Avirame K, Rodriguez AD, Lindenberg R, Floel A. Transcranial direct current stimulation over multiple days improves learning and maintenance of a novel vocabulary. Cortex. 2014 Jan;50:137-47. doi: 10.1016/j.cortex.2013.07.013. Epub 2013 Aug 6.
Reis J, Schambra HM, Cohen LG, Buch ER, Fritsch B, Zarahn E, Celnik PA, Krakauer JW. Noninvasive cortical stimulation enhances motor skill acquisition over multiple days through an effect on consolidation. Proc Natl Acad Sci U S A. 2009 Feb 3;106(5):1590-5. doi: 10.1073/pnas.0805413106. Epub 2009 Jan 21.
Cohen Kadosh R, Soskic S, Iuculano T, Kanai R, Walsh V. Modulating neuronal activity produces specific and long-lasting changes in numerical competence. Curr Biol. 2010 Nov 23;20(22):2016-20. doi: 10.1016/j.cub.2010.10.007. Epub 2010 Nov 4.
Vestito L, Rosellini S, Mantero M, Bandini F. Long-term effects of transcranial direct-current stimulation in chronic post-stroke aphasia: a pilot study. Front Hum Neurosci. 2014 Oct 14;8:785. doi: 10.3389/fnhum.2014.00785. eCollection 2014.
Gandiga PC, Hummel FC, Cohen LG. Transcranial DC stimulation (tDCS): a tool for double-blind sham-controlled clinical studies in brain stimulation. Clin Neurophysiol. 2006 Apr;117(4):845-50. doi: 10.1016/j.clinph.2005.12.003. Epub 2006 Jan 19.
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Iyer MB, Mattu U, Grafman J, Lomarev M, Sato S, Wassermann EM. Safety and cognitive effect of frontal DC brain polarization in healthy individuals. Neurology. 2005 Mar 8;64(5):872-5. doi: 10.1212/01.WNL.0000152986.07469.E9.
Brunoni AR, Amadera J, Berbel B, Volz MS, Rizzerio BG, Fregni F. A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Int J Neuropsychopharmacol. 2011 Sep;14(8):1133-45. doi: 10.1017/S1461145710001690. Epub 2011 Feb 15.
Pillay SB, Stengel BC, Humphries C, Book DS, Binder JR. Cerebral localization of impaired phonological retrieval during rhyme judgment. Ann Neurol. 2014 Nov;76(5):738-46. doi: 10.1002/ana.24266. Epub 2014 Sep 19.
Saffran EM, Marin OS. Reading without phonology: evidence from aphasia. Q J Exp Psychol. 1977 Aug;29(3):515-25. doi: 10.1080/14640747708400627. No abstract available.
Caramazza A, Berndt RS, Basili AG. The selective impairment of phonological processing: a case study. Brain Lang. 1983 Jan;18(1):128-74. doi: 10.1016/0093-934x(83)90011-1.
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Pillay SB, Gross WL, Graves WW, Humphries C, Book DS, Binder JR. The Neural Basis of Successful Word Reading in Aphasia. J Cogn Neurosci. 2018 Apr;30(4):514-525. doi: 10.1162/jocn_a_01214. Epub 2017 Dec 6.
Binder JR, Desai RH, Graves WW, Conant LL. Where is the semantic system? A critical review and meta-analysis of 120 functional neuroimaging studies. Cereb Cortex. 2009 Dec;19(12):2767-96. doi: 10.1093/cercor/bhp055. Epub 2009 Mar 27.
U.S. Census Bureau. State & County QuickFacts: Milwaukee County, Wisconsin [Internet]. [date unknown];[cited 2018 Jan 11 ] Available from: https://factfinder.census.gov/faces/tableservices/jsf/pages/productview.xhtml?src=CF
Poreisz C, Boros K, Antal A, Paulus W. Safety aspects of transcranial direct current stimulation concerning healthy subjects and patients. Brain Res Bull. 2007 May 30;72(4-6):208-14. doi: 10.1016/j.brainresbull.2007.01.004. Epub 2007 Jan 24.
Wilson SM, Yen M, Eriksson DK. An adaptive semantic matching paradigm for reliable and valid language mapping in individuals with aphasia. Hum Brain Mapp. 2018 Aug;39(8):3285-3307. doi: 10.1002/hbm.24077. Epub 2018 Apr 17.
Yen M, DeMarco AT, Wilson SM. Adaptive paradigms for mapping phonological regions in individual participants. Neuroimage. 2019 Apr 1;189:368-379. doi: 10.1016/j.neuroimage.2019.01.040. Epub 2019 Jan 18.
Nitsche MA, Liebetanz D, Lang N, Antal A, Tergau F, Paulus W. Safety criteria for transcranial direct current stimulation (tDCS) in humans. Clin Neurophysiol. 2003 Nov;114(11):2220-2; author reply 2222-3. doi: 10.1016/s1388-2457(03)00235-9. No abstract available.
Other Identifiers
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PRO00046308
Identifier Type: -
Identifier Source: org_study_id
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