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Transcranial Magnetic Stimulation (TMS) in Schizophrenia
This study is currently recruiting participants.
Verified by BeerYaakov Mental Health Center, January 2009
First Received: November 25, 2007   Last Updated: January 25, 2009   History of Changes
Sponsors and Collaborators: BeerYaakov Mental Health Center
Weizmann Institute of Science
Information provided by: BeerYaakov Mental Health Center
ClinicalTrials.gov Identifier: NCT00564096
  Purpose

Until recently stimulation of nervous tissue deeper than approximately 2 cm from the scalp (will hence be called non-deep TMS) was not possible (3).A new coil ("H"-coil invented in Weizmann Institute of Science, Neurobiology Department, Rehovot, Israel ) capable of stimulating more than twice this depth (Up to 5 cm)was recently developed.Deep TMS is using this h-coil. Auditory hallucinations are reported by 50% to 70% of patients with schizophrenia and generally consist of spoken speech or "voices." .

Patients usually describe the hallucinatory experience as distressing, consistent with evidence that the most common hallucinated utterances are abusive terms,contributing in up to 25% of the cases to a serious suicide attempt.The neuroanatomical basis of auditory hallucinations is thought to involve increasing blood flow of the speech perception areas of the brain, such as the superior temporal cortex of the dominant hemisphere as well as right and left superior temporal cortex.Brain imaging studies of patients with auditory hallucinations have revealed an active area in the right and left superior temporal cortex, Broca's area, and the left temporoparietal cortex. Shergill et al. reported the presence of active areas in the anterior cingulate cortex, right thalamus, left hippocampus, and parahippocampal cortex when subjects were experiencing auditory hallucinations.

Magnetic Stimulation of Left Temporoparietal Cortex suggest that the mechanism of auditory hallucinations involves activation of the left temporoparietal cortex.Reasons to believe that right frontotemporal TMS stimulation cortex can ameliorate auditory hallucinations include evidence that right temporoparietal stimulation achieved significant changes in the frequency of auditory hallucinations,in the patients with auditory hallucinations an increase in blood flow is noted in the right superior temporal gyrus,right temporal lobe activation during auditory hallucination,effect of rTMS can spread to the opposite hemisphere through interhemispheric connections,some evidence that brain circuits involved in the production of auditory hallucinations and symptoms of schizophrenia are widespread and not confined in the left temporoparietal cortex.Deep TMS can reach brain structures as deep as 5 cm whereas non-deep TMS can reach structures less than half that distance. As deep brain structures such as thalamic, limbic and paralimbic regions have been shown to be activated during auditory hallucinations and suspected to play a role in the pathogenesis of auditory hallucinations, their stimulation may attenuate auditory hallucinations. Non-deep TMS can stimulate the cortex but not the neuronal pathways connecting it to deeper brain structures and which stimulation may be additive.


Condition Intervention Phase
Schizophrenia
Device: DEEP TMS
Phase II
Phase III

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources
Study Type: Interventional
Study Design: Basic Science, Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study
Official Title: Research of Deep TMS Treatment in Patients With Schizophrenia Experiencing Auditory Hallucinations an Open Study

Further study details as provided by BeerYaakov Mental Health Center:

Primary Outcome Measures:
  • 1.Auditory hallucinations Rating Scale developed by Hoffman and colleagues (2003) 2.SAPS 3.CGI 4.SANS [ Time Frame: Prospective ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: October 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1- TMS left: Experimental
Ten patients will be given 10 minutes stimulation with deep H-Coil TMS to the Left Temporoparietal Cortex in frequency of 1 Hz with 110% motor threshold during 10 consecutive working days
Device: DEEP TMS
A new coil ("H"-coil invented in Weizmann Institute of Science, Neurobiology Department, Rehovot, Israel) capable of stimulating more than twice this depth (Up to 5 cm) was recently developed and hence will be called deep TMS.
2- TMS right: Experimental
Ten patients will be given 10 minutes stimulation with deep H-Coil TMS to the Right fronto-temporal Cortex in frequency of 1 Hz with 110% motor threshold during 10 consecutive working days
Device: DEEP TMS
A new coil ("H"-coil invented in Weizmann Institute of Science, Neurobiology Department, Rehovot, Israel) capable of stimulating more than twice this depth (Up to 5 cm) was recently developed and hence will be called deep TMS.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients will fulfill DSM-IV-TR diagnostic criteria for schizophrenia
  • Patients reporting auditory hallucinations on average at least 5 times per day based on prospective assessment using a diary or handheld counter.
  • Patients are maintained on their psychotropic medication at steady dosages for at least 4 weeks before study entry and for the duration of the trial.

Exclusion Criteria:

  • Cardiac pacemaker implant, or a history of epilepsy, neurosurgery, or brain trauma patients suffering from chronic medical conditions of any sort
  • History of current hypertension
  • History of seizure or heat convulsion
  • History of epilepsy or seizure in first degree relatives
  • History of head injury
  • History of any metal in the head (outside the mouth)
  • Known history of any metallic particles in the eye
  • Implanted cardiac pacemaker or any intra-cardiac lines
  • Implanted neuro-stimulators
  • Surgical clips or any medical pumps
  • History of frequent or severe headaches
  • History of migraine
  • History of hearing loss
  • Known history of cochlear implants
  • History of drug abuse or alcoholism
  • Pregnancy or not using a reliable method of birth control (non-pregnancy will be proved by beta-HCG test)
  • Systemic and metabolic disorders
  • Inadequate communication skills or under custodial care.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00564096

Contacts
Contact: Oded Rosenderg, M.D. 972-8-9206398 oded35@netvision.net.il

Locations
Israel
Beer-Yaacov MHC Recruiting
Beer Yaacov, Israel, 70350
Contact: Dr.Rosenberg     97289258396     research@beerness.health.gov.il    
Principal Investigator: Oded Rosenberg, M.D.            
Sponsors and Collaborators
BeerYaakov Mental Health Center
Weizmann Institute of Science
Investigators
Principal Investigator: Oded Rosenberg, M.D. Beer Yaakov Mental Health Center
  More Information

No publications provided

Responsible Party: Beer Yaakov ( Dr. Oded Rosenberg )
Study ID Numbers: TMS-218CTIL, HT4413
Study First Received: November 25, 2007
Last Updated: January 25, 2009
ClinicalTrials.gov Identifier: NCT00564096     History of Changes
Health Authority: United States: Food and Drug Administration;   Israel: Ministry of Health

Study placed in the following topic categories:
Schizophrenia
Mental Disorders
Hallucinations
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 07, 2009