CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 85 enrolled
Drug / intervention
1-hertz Repetitive Transcranial Magnetic Stimulation +1 moredevice
Likely dose
1-Hertz repetitive transcranial magnetic stimulation: 16 minutes per session, 5 days per week for weeks I and II (with hemisphere switch), then 5 additional sessions (16 minutes each) to the side producing greater benefit in week IIIAI-extracted
Key inclusion· 2
  • Auditory hallucinations occurring at least 5 times per day on average
  • Diagnosis of schizophrenia or schizoaffective disorder
Key exclusion· 9
  • Pregnant
  • History of non-drug-induced or non-alcohol-withdrawal seizure
  • Drug or alcohol abuse within 6 weeks of study entry
  • Antipsychotic dose changes within 4 weeks of study entry

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

Search/NCT00308997
NCT00308997Phase 2Completed

Transcranial Magnetic Stimulation Guided by Neuroimaging for Patients With Persistent "Voices"

Yale University·interventional·Posted Mar 30, 2006·Updated Apr 2, 2020

In Brief

A Phase 2 clinical trial evaluating 1-hertz Repetitive Transcranial Magnetic Stimulation and Active 1-Hertz Repetitive transcranial magnetic stimulation for Schizophrenia and Hallucinations. Completed, enrolled 85 participants across 1 site.

Detailed Summary

This study will determine the efficacy of MRI-guided transcranial magnetic stimulation (TMS)in reducing "voices" and other symptoms experienced by people with schizophrenia and schizoaffective disorder. In addition, the study will determine duration of improvement obtained during the course of trial participation via on-going monthly contact with study participants for up to 1 year after the trial.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 30, 2006
Enrollment StartFeb 1, 2006
Primary CompletionSep 1, 2011
Study CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 20.3 years ago

Interventions

1-hertz Repetitive Transcranial Magnetic Stimulationdevice

Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III.

Active 1-Hertz Repetitive transcranial magnetic stimulationdevice

Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III.