Therapeutic Efficacy of Transcranial Magnetic Stimulation in Schizophrenia
NCT ID: NCT01551979
Last Updated: 2018-04-12
Study Results
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View full resultsBasic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2012-02-29
2015-11-30
Brief Summary
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Detailed Description
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The primary goal of the present study is to assess efficacy of iTBS to the cerebellar vermis on positive and negative symptoms of schizophrenia. A second, added goal is to investigate the mechanisms of the expected clinical improvement.
Schizophrenia is a leading cause of mental disability and current treatments still remain only partially successful for many patients. Our underlying hypothesis is that modulation of the cerebellar vermis may enhance activity of the neural systems that sub-serve cognition and emotion, reestablish the disturbed cerebellar regulation in schizophrenic patients, and produce clinical improvement.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Active rTMS
High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.
Repetitive Transcranial Magnetic Stimulation
intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.
Sham participants will undergo the same procedures as those in the active rTMS group.
Sham rTMS
Sham rTMS to the vermis (lobule VII) of the cerebellum.
Repetitive Transcranial Magnetic Stimulation
intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.
Sham participants will undergo the same procedures as those in the active rTMS group.
Interventions
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Repetitive Transcranial Magnetic Stimulation
intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.
Sham participants will undergo the same procedures as those in the active rTMS group.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of schizophrenia according to DSM-IV criteria (Diagnostic and Statistical Manual) by a board-certified psychiatrist
Exclusion Criteria
* Prior neurological procedures
* Previous head injury
* Change in antipsychotic medication during the last 4 weeks
* Been an inpatient in a psychiatry clinic within the last month
* Any other axis 1 diagnosis
* Patients may not be actively enrolled in a separate intervention study
* Patients unable to undergo a brain MRI
* Any unstable medical condition
* History of seizures, diagnosis of epilepsy, history of abnormal (epileptiform\_ EEG, or family history of treatment resistant epilepsy
* Possible pregnancy. All female participants of child bearing age are required to have a pregnancy test.
* Any metal in the brain, skull, or elsewhere unless approved by the responsible MD
* Any medical devices (ie. cardiac pacemaker, deep brain stimulator, medication infusion pump, cochlear implant, vagal nerve stimulator) unless otherwise approved by the responsible MD
* Substance abuse (alcohol, amphetamines, cocaine, MDMA \[methylenedioxymethamphetamine\], ecstasy, PCP \[phencyclidine\], Angle dust) or dependence within the past six months
* No medication is an absolute exclusion from TMS. Medications will be reviewed by the responsible MD and a decision about inclusion will be made based on the following: the patient's past medical history, drug dose, history of recent medication changes or duration of treatment, and combination with other CNS (central nervous system) active drugs (the published TMS guidelines review of medications to be considered with TMS)
18 Years
65 Years
ALL
No
Sponsors
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Sidney R. Baer, Jr. Foundation
OTHER
Beth Israel Deaconess Medical Center
OTHER
Responsible Party
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Mark Halko
Instructor in Neurology
Principal Investigators
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Mark Halko, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Countries
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References
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Demirtas-Tatlidede A, Freitas C, Cromer JR, Safar L, Ongur D, Stone WS, Seidman LJ, Schmahmann JD, Pascual-Leone A. Safety and proof of principle study of cerebellar vermal theta burst stimulation in refractory schizophrenia. Schizophr Res. 2010 Dec;124(1-3):91-100. doi: 10.1016/j.schres.2010.08.015.
Demirtas-Tatlidede A, Freitas C, Pascual-Leone A, Schmahmann JD. Modulatory effects of theta burst stimulation on cerebellar nonsomatic functions. Cerebellum. 2011 Sep;10(3):495-503. doi: 10.1007/s12311-010-0230-5.
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Fregni F, Thome-Souza S, Bermpohl F, Marcolin MA, Herzog A, Pascual-Leone A, Valente KD. Antiepileptic effects of repetitive transcranial magnetic stimulation in patients with cortical malformations: an EEG and clinical study. Stereotact Funct Neurosurg. 2005;83(2-3):57-62. doi: 10.1159/000086674. Epub 2005 Jun 30.
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George MS, Wassermann EM, Williams WA, Callahan A, Ketter TA, Basser P, Hallett M, Post RM. Daily repetitive transcranial magnetic stimulation (rTMS) improves mood in depression. Neuroreport. 1995 Oct 2;6(14):1853-6. doi: 10.1097/00001756-199510020-00008.
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Heath RG. Modulation of emotion with a brain pacemamer. Treatment for intractable psychiatric illness. J Nerv Ment Dis. 1977 Nov;165(5):300-17.
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Huber TJ, Schneider U, Rollnik J. Gender differences in the effect of repetitive transcranial magnetic stimulation in schizophrenia. Psychiatry Res. 2003 Aug 30;120(1):103-5. doi: 10.1016/s0165-1781(03)00170-7.
Jardri R, Lucas B, Delevoye-Turrell Y, Delmaire C, Delion P, Thomas P, Goeb JL. An 11-year-old boy with drug-resistant schizophrenia treated with temporo-parietal rTMS. Mol Psychiatry. 2007 Apr;12(4):320. doi: 10.1038/sj.mp.4001968. No abstract available.
Jin Y, Potkin SG, Kemp AS, Huerta ST, Alva G, Thai TM, Carreon D, Bunney WE Jr. Therapeutic effects of individualized alpha frequency transcranial magnetic stimulation (alphaTMS) on the negative symptoms of schizophrenia. Schizophr Bull. 2006 Jul;32(3):556-61. doi: 10.1093/schbul/sbj020. Epub 2005 Oct 27.
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Rollnik JD, Huber TJ, Mogk H, Siggelkow S, Kropp S, Dengler R, Emrich HM, Schneider U. High frequency repetitive transcranial magnetic stimulation (rTMS) of the dorsolateral prefrontal cortex in schizophrenic patients. Neuroreport. 2000 Dec 18;11(18):4013-5. doi: 10.1097/00001756-200012180-00022.
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Related Links
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Related Information
Other Identifiers
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2011P000373
Identifier Type: -
Identifier Source: org_study_id
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