Transcranial Direct Current Stimulation and Cognitive Remediation Therapy for Interictal Dysfunction in Epilepsy
NCT ID: NCT02950506
Last Updated: 2022-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2020-01-01
2020-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Active tDCS
There will be a total of 14 visits in the study: will complete a screening visit, an initial visit, 10 session visits with active tDCS(transcranial direct current stimulation) andcognitive remediation therapy, and follow--up visits immediately (within 5 days), 1 and 3 months after the last intervention. Subjects will be informed of their group assignment at the end of the study.
transcranial direct current stimulation
The anode will be placed over left DLPFC at F3, according to the 10-20 international system for EEG electrode placement. The cathode will be placed over the contralateral supraorbital area. They will be placed via two saline soaked electrode sponges (3 cm x 4.5 cm).After electrodes have been placed, the participants will be instructed to log into CRT software using a unique patient identifier. The CRT software that will be used will be Cogmed working memory training program (Pearson Education, Inc.)Active tDCS will be applied at a ramp-like fashion from 0 to 2mA over 10 seconds, and will be ramped down for the last 10 seconds of stimulation. Active tDCS will last 20 minutes each session. The sham procedure involves only 30 seconds of stimulation at 2mA.
Cognitive Remediation Therapy
The CRT software that will be used will be Cogmed working memory training program (Pearson Education, Inc.). Cogmed is a targeted computerized training program that has been shown to improve working memory and attention. (Spencer-Smith 2015).
Sham tDCS
There will be a total of 14 visits in the study: will complete a screening visit, an initial visit, 10 session visits with sham tDCS and cognitive remediation therapy, and follow--up visits immediately (within 5 days), 1 and 3 months after the last intervention. Subjects will be informed of their group assignment at the end of the study.
Cognitive Remediation Therapy
The CRT software that will be used will be Cogmed working memory training program (Pearson Education, Inc.). Cogmed is a targeted computerized training program that has been shown to improve working memory and attention. (Spencer-Smith 2015).
Interventions
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transcranial direct current stimulation
The anode will be placed over left DLPFC at F3, according to the 10-20 international system for EEG electrode placement. The cathode will be placed over the contralateral supraorbital area. They will be placed via two saline soaked electrode sponges (3 cm x 4.5 cm).After electrodes have been placed, the participants will be instructed to log into CRT software using a unique patient identifier. The CRT software that will be used will be Cogmed working memory training program (Pearson Education, Inc.)Active tDCS will be applied at a ramp-like fashion from 0 to 2mA over 10 seconds, and will be ramped down for the last 10 seconds of stimulation. Active tDCS will last 20 minutes each session. The sham procedure involves only 30 seconds of stimulation at 2mA.
Cognitive Remediation Therapy
The CRT software that will be used will be Cogmed working memory training program (Pearson Education, Inc.). Cogmed is a targeted computerized training program that has been shown to improve working memory and attention. (Spencer-Smith 2015).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Epilepsy diagnosis confirmed by the UMN Comprehensive Epilepsy Center
* Complete seizure logs of the type in standard clinic use at the UMN Comprehensive Epilepsy Center for at least 12 weeks prior to study entry
* Stable CNS medications for the 2 weeks prior to the initiation visit and expected to continue with current medication doses for the two weeks of the intervention
* No diagnosis of mental retardation (IQ not less than 70) or pervasive developmental disorder
* At least one subtest of learning and memory less than --1.5 SD
* Sufficient spoken English so as to be able to comprehend testing procedures
* Competent and willing to provide consent
Exclusion Criteria
* Occurrence of more than 1 generalized tonic-clonic (GTC) seizure per month, or more than 4 complex partial (CP) seizures per week, as reported in the subject's seizure logs for 12 weeks prior to study entry
* Occurrence of GTC seizure within 48 hours before testing
* Any anti-epileptic medication changes or hospitalizations in the previous 4 weeks
* Additional neurologic disorder other epilepsy and cognitive dysfunctions
* History of metallic cranial plates, screws, or implanted devices
* History of craniotomy
18 Years
64 Years
ALL
No
Sponsors
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University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Thomas Henry, MD
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Locations
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University of Minnesota Comprehensive Epilepsy Center(MINCEP)
Saint Louis Park, Minnesota, United States
Countries
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References
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Andrews SC, Hoy KE, Enticott PG, Daskalakis ZJ, Fitzgerald PB. Improving working memory: the effect of combining cognitive activity and anodal transcranial direct current stimulation to the left dorsolateral prefrontal cortex. Brain Stimul. 2011 Apr;4(2):84-9. doi: 10.1016/j.brs.2010.06.004. Epub 2010 Jul 11.
Benedict, Ralph H B, David Schretlen, Lowell Groninger, and Jason Brandt. 1998. "Hopkins Verbal Learning Test - Revised: Normative Data and Analysis of Inter-Form and Test-Retest Reliability." The Clinical Neuropsychologist 12 (1): 43-55.
Benson N, Hulac DM, Kranzler JH. Independent examination of the Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV): what does the WAIS-IV measure? Psychol Assess. 2010 Mar;22(1):121-30. doi: 10.1037/a0017767.
Boggio PS, Ferrucci R, Rigonatti SP, Covre P, Nitsche M, Pascual-Leone A, Fregni F. Effects of transcranial direct current stimulation on working memory in patients with Parkinson's disease. J Neurol Sci. 2006 Nov 1;249(1):31-8. doi: 10.1016/j.jns.2006.05.062. Epub 2006 Jul 14.
Brandt, J. & Benedict, R. (2001). Hopkins Verbal Learning Test-Revised: Professional Manual. PAR: Florida
Brunelin J, Mondino M, Haesebaert F, Saoud M, Suaud-Chagny MF, Poulet E. Efficacy and safety of bifocal tDCS as an interventional treatment for refractory schizophrenia. Brain Stimul. 2012 Jul;5(3):431-432. doi: 10.1016/j.brs.2011.03.010. Epub 2011 Apr 24. No abstract available.
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.
Cramer JA, Perrine K, Devinsky O, Bryant-Comstock L, Meador K, Hermann B. Development and cross-cultural translations of a 31-item quality of life in epilepsy inventory. Epilepsia. 1998 Jan;39(1):81-8. doi: 10.1111/j.1528-1157.1998.tb01278.x.
Del Felice A, Magalini A, Masiero S. Slow-oscillatory Transcranial Direct Current Stimulation Modulates Memory in Temporal Lobe Epilepsy by Altering Sleep Spindle Generators: A Possible Rehabilitation Tool. Brain Stimul. 2015 May-Jun;8(3):567-73. doi: 10.1016/j.brs.2015.01.410. Epub 2015 Jan 30.
Denboer, John W, Christopher Nicholls, Corrine Corte, and Kali Chestnut. 2014. "National Institutes of Health Toolbox Cognition Battery." Archives of Clinical Neuropsychology: The Official Journal of the National Academy of Neuropsychologists, August. doi:10.1093/arclin/acu033.
Dikmen SS, Bauer PJ, Weintraub S, Mungas D, Slotkin J, Beaumont JL, Gershon R, Temkin NR, Heaton RK. Measuring episodic memory across the lifespan: NIH Toolbox Picture Sequence Memory Test. J Int Neuropsychol Soc. 2014 Jul;20(6):611-9. doi: 10.1017/S1355617714000460. Epub 2014 Jun 24.
Engelberts NH, Klein M, Ader HJ, Heimans JJ, Trenite DG, van der Ploeg HM. The effectiveness of cognitive rehabilitation for attention deficits in focal seizures: a randomized controlled study. Epilepsia. 2002 Jun;43(6):587-95. doi: 10.1046/j.1528-1157.2002.29401.x.
Falleti MG, Maruff P, Collie A, Darby DG. Practice effects associated with the repeated assessment of cognitive function using the CogState battery at 10-minute, one week and one month test-retest intervals. J Clin Exp Neuropsychol. 2006 Oct;28(7):1095-112. doi: 10.1080/13803390500205718.
Fregni F, Thome-Souza S, Nitsche MA, Freedman SD, Valente KD, Pascual-Leone A. A controlled clinical trial of cathodal DC polarization in patients with refractory epilepsy. Epilepsia. 2006 Feb;47(2):335-42. doi: 10.1111/j.1528-1167.2006.00426.x.
Fregni F, Boggio PS, Nitsche M, Bermpohl F, Antal A, Feredoes E, Marcolin MA, Rigonatti SP, Silva MT, Paulus W, Pascual-Leone A. Anodal transcranial direct current stimulation of prefrontal cortex enhances working memory. Exp Brain Res. 2005 Sep;166(1):23-30. doi: 10.1007/s00221-005-2334-6. Epub 2005 Jul 6.
Gazzaley A. Influence of early attentional modulation on working memory. Neuropsychologia. 2011 May;49(6):1410-24. doi: 10.1016/j.neuropsychologia.2010.12.022. Epub 2010 Dec 22.
Haut KM, Lim KO, MacDonald A 3rd. Prefrontal cortical changes following cognitive training in patients with chronic schizophrenia: effects of practice, generalization, and specificity. Neuropsychopharmacology. 2010 Aug;35(9):1850-9. doi: 10.1038/npp.2010.52. Epub 2010 Apr 28.
Heaton RK, Akshoomoff N, Tulsky D, Mungas D, Weintraub S, Dikmen S, Beaumont J, Casaletto KB, Conway K, Slotkin J, Gershon R. Reliability and validity of composite scores from the NIH Toolbox Cognition Battery in adults. J Int Neuropsychol Soc. 2014 Jul;20(6):588-98. doi: 10.1017/S1355617714000241. Epub 2014 Jun 24.
Henry TR, Roman DD. Presurgical epilepsy localization with interictal cerebral dysfunction. Epilepsy Behav. 2011 Feb;20(2):194-208. doi: 10.1016/j.yebeh.2010.12.008. Epub 2011 Jan 22.
Johnson MD, Lim HH, Netoff TI, Connolly AT, Johnson N, Roy A, Holt A, Lim KO, Carey JR, Vitek JL, He B. Neuromodulation for brain disorders: challenges and opportunities. IEEE Trans Biomed Eng. 2013 Mar;60(3):610-24. doi: 10.1109/TBME.2013.2244890. Epub 2013 Feb 1.
Jo JM, Kim YH, Ko MH, Ohn SH, Joen B, Lee KH. Enhancing the working memory of stroke patients using tDCS. Am J Phys Med Rehabil. 2009 May;88(5):404-9. doi: 10.1097/PHM.0b013e3181a0e4cb.
Lin JJ, Mula M, Hermann BP. Uncovering the neurobehavioural comorbidities of epilepsy over the lifespan. Lancet. 2012 Sep 29;380(9848):1180-92. doi: 10.1016/S0140-6736(12)61455-X.
Loring DW, Strauss E, Hermann BP, Barr WB, Perrine K, Trenerry MR, Chelune G, Westerveld M, Lee GP, Meador KJ, Bowden SC. Differential neuropsychological test sensitivity to left temporal lobe epilepsy. J Int Neuropsychol Soc. 2008 May;14(3):394-400. doi: 10.1017/S1355617708080582.
Mattioli F, Bellomi F, Stampatori C, Capra R, Miniussi C. Neuroenhancement through cognitive training and anodal tDCS in multiple sclerosis. Mult Scler. 2016 Feb;22(2):222-30. doi: 10.1177/1352458515587597. Epub 2015 May 26.
Medalia A, Revheim N, & Herlands T. Cognitive remediation for psychological disorders: therapist guide. Treatments that work. Oxford ; New York: Oxford University Press, 2009.
Golden, Charles J. 2002. "Stroop Color and Word Test : A Manual for Clinical and Experimental Uses". Wood Dale, IL.
Nitsche MA, Cohen LG, Wassermann EM, Priori A, Lang N, Antal A, Paulus W, Hummel F, Boggio PS, Fregni F, Pascual-Leone A. Transcranial direct current stimulation: State of the art 2008. Brain Stimul. 2008 Jul;1(3):206-23. doi: 10.1016/j.brs.2008.06.004. Epub 2008 Jul 1.
Nowinski CJ, Victorson D, Cavazos JE, Gershon R, Cella D. Neuro-QOL and the NIH Toolbox: implications for epilepsy. Therapy. 2010 Sep 1;7(5):533-540. doi: 10.2217/thy.10.55.
Oliveira JF, Zanao TA, Valiengo L, Lotufo PA, Bensenor IM, Fregni F, Brunoni AR. Acute working memory improvement after tDCS in antidepressant-free patients with major depressive disorder. Neurosci Lett. 2013 Mar 14;537:60-4. doi: 10.1016/j.neulet.2013.01.023. Epub 2013 Jan 28.
Oyegbile TO, Dow C, Jones J, Bell B, Rutecki P, Sheth R, Seidenberg M, Hermann BP. The nature and course of neuropsychological morbidity in chronic temporal lobe epilepsy. Neurology. 2004 May 25;62(10):1736-42. doi: 10.1212/01.wnl.0000125186.04867.34.
Ponds RW, Hendriks M. Cognitive rehabilitation of memory problems in patients with epilepsy. Seizure. 2006 Jun;15(4):267-73. doi: 10.1016/j.seizure.2006.02.011. Epub 2006 Mar 23.
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.
Rzezak P, Moschetta SP, Lima E, Castro CX, Vincentiis S, Coan AC, Guerreiro C, Filho GB, Valente KD. Distinct domains of impulsivity are impaired in juvenile myoclonic epilepsy but not in temporal lobe epilepsy. Epilepsy Behav. 2015 Apr;45:44-8. doi: 10.1016/j.yebeh.2015.02.028. Epub 2015 Mar 25.
Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.
Spencer-Smith M, Klingberg T. Benefits of a working memory training program for inattention in daily life: a systematic review and meta-analysis. PLoS One. 2015 Mar 20;10(3):e0119522. doi: 10.1371/journal.pone.0119522. eCollection 2015.
Strauss E, Sherman E, Spreen O (2006). Rey Auditory Verbal Learning Test. In Compendium of Neuropsychological Tests (3rd Edition) Oxford University Press.776- 807
Tam JW, Schmitter-Edgecombe M. The role of processing speed in the Brief Visuospatial Memory Test - revised. Clin Neuropsychol. 2013;27(6):962-72. doi: 10.1080/13854046.2013.797500. Epub 2013 May 20.
Weintraub S, Dikmen SS, Heaton RK, Tulsky DS, Zelazo PD, Slotkin J, Carlozzi NE, Bauer PJ, Wallner-Allen K, Fox N, Havlik R, Beaumont JL, Mungas D, Manly JJ, Moy C, Conway K, Edwards E, Nowinski CJ, Gershon R. The cognition battery of the NIH toolbox for assessment of neurological and behavioral function: validation in an adult sample. J Int Neuropsychol Soc. 2014 Jul;20(6):567-78. doi: 10.1017/S1355617714000320. Epub 2014 Jun 24.
Other Identifiers
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CTSI24219
Identifier Type: -
Identifier Source: org_study_id
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