Transcranial Magnetic Stimulation (TMS) in Schizophrenia

NCT00564096 | Unknown Phase 2

• 2 other identifiers: TMS-218CTILHT4413
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• 1.Auditory hallucinations Rating Scale developed by Hoffman and colleagues (2003) 2.SAPS 3.CGI 4.SANS 5.GAF

  Prospective

Secondary Outcomes (3)

• Q-LES-Q

  prospective

• QIDS-SR16

  prospective

• CTAHE

  prospective

Study Arms (2)

Real TMS

ACTIVE COMPARATOR

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

Sham & real TMS

PLACEBO COMPARATOR

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

Interventions

DEEP TMS H1 coil DEVICE

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.

Real TMS

Deep H1 coil TMS DEVICE

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.

Sham & real TMS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• BeerYaakov Mental Health Center: lead
• Weizmann Institute of Science: collaborator

Study Sites (1)

Beer-Yaacov MHC

Beer Yaacov, Israel, 70350, Israel

RECRUITING

Related Publications (2)

• Rosenberg O, Gersner R, Klein LD, Kotler M, Zangen A, Dannon P. Deep transcranial magnetic stimulation add-on for the treatment of auditory hallucinations: a double-blind study. Ann Gen Psychiatry. 2012 May 6;11:13. doi: 10.1186/1744-859X-11-13.

  PMID: 22559192 DERIVED

• Rosenberg O, Roth Y, Kotler M, Zangen A, Dannon P. Deep transcranial magnetic stimulation for the treatment of auditory hallucinations: a preliminary open-label study. Ann Gen Psychiatry. 2011 Feb 9;10(1):3. doi: 10.1186/1744-859X-10-3.

  PMID: 21303566 DERIVED

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Oded Rosenberg, M.D.

  Beer Yaakov Mental Health Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oded Rosenderg, M.D.

CONTACT

972-8-9206398; oded35@netvision.net.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: November 25, 2007
• First Posted: November 27, 2007
• Study Start: October 1, 2008
• Primary Completion: November 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 3, 2010

Record last verified: 2009-10

Locations

IL (1)