Completed

Repetitive Transcranial Magnetic Stimulation of Speech Processing Brain Areas in Schizophrenic Patients Who Hear "Voices"

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What is being tested

repetitive transcranial magnetic stimulation (rTMS)

+ sham stimulation

Device
Who is being recruted

Nervous System Diseases+7

+ Pathologic Processes

+ Signs and Symptoms

From 18 to 60 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: December 1999
See protocol details

Summary

Principal SponsorYale University
Last updated: August 7, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 1999

Actual date on which the first participant was enrolled.

PROTOCOL OUTLINE: This is a randomized, double blind study. Patients are randomized to one of two treatment arms. Group I: Patients receive 9 sessions of active transcranial magnetic stimulation (rTMS) which consists of 8 minutes of rTMS during session 1, 12 minutes duration during session 2, and 16 minutes duration during sessions 3-9. The total duration of stimulation is 132 minutes. Each session was given on a separate day and in general each session occurred on consecutive days with the exception of weekends. Group II: Patients receive 9 sessions of sham stimulation, which consists of 8 minutes of sham stimulation during session 1, 12 minutes duration sham stimulation during session 2, and 16 minutes duration sham stimulation during sessions 3-9. The total duration of sham stimulation is 132 minutes. Each session was given conducted on a separate day and in general each session occured on consecutive days with the exception of weekends. This study provided pilot data supplying the basis for our current study - NCT00308997 -- see our website for details

NCT00004980
Principal SponsorYale University
Last updated: August 7, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Nervous System DiseasesPathologic ProcessesSigns and SymptomsPathological Conditions, Signs and SymptomsSchizophrenia Spectrum and Other Psychotic DisordersDisease AttributesMental DisordersNeurologic ManifestationsSchizophreniaRare Diseases

Criteria

11 exclusion criteria prevent from participating
active drug or alcohol abuse within prior 6 weeks
cardiac pacemaker
cochlear implants or other metal in the head (surgical, etc.)
current treatment with clozapine or bupropion
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
1-Hz rTMS delivered to left temporoparietal cortex at 90% motor threshold for 16 minutes per session given one session per day for nine consecutive days (with the exception of weekends)

Group II

Placebo
Sham stimulation delivered 16 minutes per session given one session per day for nine consecutive days (with the exception of weekends)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Yale University School of Medicine

New Haven, United StatesOpen Yale University School of Medicine in Google Maps
CompletedOne Study Center