Transcranial Magnetic Stimulation (TMS) in Schizophrenia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by BeerYaakov Mental Health Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Weizmann Institute of Science
Information provided by:
BeerYaakov Mental Health Center
ClinicalTrials.gov Identifier:
NCT00564096
First received: November 25, 2007
Last updated: March 2, 2010
Last verified: October 2009
  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 H1 coil
Device: Deep H1 coil TMS
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: A Prospective Multicenter Double Blind Randomized Controlled Trial to Explore the Tolerability, Safety and Efficacy of the H1-Coil Deep Transcranial Magnetic Stimulation (TMS) in Subjects With Schizophrenia Experiencing Auditory Hallucinations

Resource links provided by NLM:


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 5.GAF [ Time Frame: Prospective ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Q-LES-Q [ Time Frame: prospective ] [ Designated as safety issue: No ]
    Quality of Life Enjoyment and Satisfaction Questionnaire

  • QIDS-SR16 [ Time Frame: prospective ] [ Designated as safety issue: No ]
    Quick Inventory of Depressive Symptomatology

  • CTAHE [ Time Frame: prospective ] [ Designated as safety issue: No ]
    The care taker evaluation will take place one week prior to first TMS session, continuing on daily basis until one week after the last TMS session. This evaluation will hence be called "Care taker auditory hallucinations evaluation" or CTAHE. The care taker will evaluate the patient's hallucinatory behavior on a scale from 0 to 10, in which "0" is completely hallucination free and "10" being behavior dictated by hallucinations alone.


Estimated Enrollment: 20
Study Start Date: October 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Real TMS
10 patients will be given 20 minutes stimulation with real deep H1-Coil TMS to the Left Temporo-parietal Cortex in frequency of 1 Hz with 120% motor threshold during 20 consecutive working days.
Device: DEEP TMS H1 coil
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.
Placebo Comparator: Sham & real TMS
10 patients will be given 20 minutes stimulation with sham deep H1-Coil TMS to the Left Temporo-parietal Cortex in frequency of 1 Hz with 120% motor threshold during 10 consecutive working days, and thereafter 20 sessions of real TMS with the same parameters (=Left Tempor-oparietal Cortex in frequency of 1 Hz with 120% motor threshold).
Device: Deep H1 coil 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Dr. Oded Rosenberg, Beer Yaakov
ClinicalTrials.gov Identifier: NCT00564096     History of Changes
Other Study ID Numbers: TMS-218CTIL, HT4413
Study First Received: November 25, 2007
Last Updated: March 2, 2010
Health Authority: United States: Food and Drug Administration
Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on July 29, 2014