CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 22 enrolled
Drug / intervention
Transcranial Magnetic Stimulation +1 moredevice
Likely dose
15 bilateral rTMS sessions administered daily, 5 days per weekAI-extracted
Key inclusion· 5
  • DSM-IV diagnosis of schizophrenia or schizoaffective disorder
  • Age over 18 years
  • Persistent negative symptoms of moderate to severe intensity
  • Failed to respond to a minimum of two antipsychotic medications
Key exclusion· 8
  • Prominent positive symptoms
  • Unstable medical condition or neurological disorder
  • History of seizure disorder
  • Currently pregnant or lactating

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00168311
NCT00168311N/ACompleted

A Double-Blind Placebo Controlled Trial of Repetitive Transcranial Magentic Stimulation (rTMS) in the Treatment of Negative Symptoms in Schizophrenia and Related Disorders

The Alfred·interventional·Posted Sep 15, 2005·Updated May 14, 2012

In Brief

A clinical study evaluating Transcranial Magnetic Stimulation and sham TMS for Schizophrenia. Completed, enrolled 22 participants across 1 site.

Detailed Summary

There is pilot data to suggest the therapeutic value of rTMS applied to the left prefrontal cortex in the treatment of negative symptoms. Neuroimaging studies demonstrate abnormal activity in this region in patients experiencing negative symptoms. Finally rTMS applied at high frequency shows the capacity to up-regulate cortical activity in a way that would provide an explanation for a therapeutic response. The study involves participants receiving 15 sessions of high frequency rTMS treatment applied bilaterally to the prefrontal cortex over a 3 week period or sham rTMS. Following this double blind phase, participants randomised to placebo treatment will be offered 15 sessions of active treatment. In addition, ppTMS (paired pulse TMS) will be conducted prior to the onset of treatment and after completion of the course, as a means of measuring cortical inhibition and facilitation. NIRS (Near Infra red spectroscopy) will also be conducted prior to, during and after the first and last treatment sessions to allow monitoring of oxygenated and deoxygenated haemoglobin.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesAustralia
Collaborators--

Timeline

N/ACompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 15, 2005
Enrollment StartAug 1, 2002
Primary CompletionJul 1, 2007
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 20.8 years ago

Interventions

Transcranial Magnetic Stimulationdevice

Participants were sequentially randomly assigned to either 15 active bilateral treatments or 15 sham bilateral treatments that were administered on a daily basis, five days per week.

sham TMSdevice