Transcranial Magnetic Stimulation for the Treatment of Auditory Hallucinations in Schizophrenia

University of Michigan

Status

Terminated

Conditions

Schizophrenia

Treatments

Procedure: rTMS with landmark-based targeting

Procedure: rTMS with fMRI-based targeting

Study type

Interventional

Funder types

Other

Identifiers

NCT01595503

HUM00046254

Details and patient eligibility

About

Repetitive transcranial magnetic stimulation (rTMS) is a new noninvasive therapy that uses magnetic energy applied to the scalp to modulate activity in the underlying regions of the brain. In this study we will examine the efficacy of treating auditory hallucinations in schizophrenia with rTMS, comparing two methods to target stimulation to a language processing region of the brain. One method targets the stimulation site using scalp landmarks, while the other uses functional magnetic resonance imaging (fMRI) combined with a language task.

Enrollment

5 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Provide signed and dated informed consent form
Male or female, aged 18 to 60
Willing to comply with all study procedures and be available for the duration of the study
Primary diagnosis of schizophrenia or schizoaffective disorder according to DSM-IV (29)
Currently reporting AHs, rated a minimum of 4 (moderate) on the auditory hallucination item of the Brief Psychiatric Rating Scale (BPRS; 27), and AH will be present daily
AHs must have failed to resolve after a minimum of two adequate trials (doses within standard therapeutic range for a minimum of 8 weeks each) of psychotropic medication including at least one atypical antipsychotic medication; documented trials of antipsychotic medication limited by intolerable side effects, e. g. extra-pyramidal symptoms, tardive dyskinesia, weight gain, neuroleptic-induced dysphoria, will also be considered as equivalent to adequate trials.
Weight and girth compatible with the bore of the MRI scanner; generally men over 6 feet tall < 250 lbs, men under 6 feet tall < 220 lbs, women over 5'11" tall < 220 lbs, or women under 5'10" tall < 200 lbs

Exclusion criteria

Substance abuse or dependence in the past 1 month
Current or past history of serious medical or neurological illness that could compromise brain function or present an increased risk of seizure, e. g. conditions that may significantly alter electrolyte balance, stroke, epilepsy, any history of seizure;
Pregnant or trying to become pregnant;
Inability to tolerate small, enclosed spaces without anxiety;
Metals, implants or metallic substances within or on the body that might cause adverse effects to the subject in a strong magnetic field, or interfere with image acquisition, e. g. aneurysm clips, retained particles, neurostimulators, foil-backed transdermal patches;
Facial tattoos with metallic ink
Inability to follow study protocol
Change in antipsychotic therapy in previous 2 weeks
Currently under an alternative treatment order
Unstable symptoms which could, in the judgment of the study team, exhibit symptomatic worsening over the course of the protocol
Current treatment with another investigational drug or other intervention
Anything that, in the opinion of the investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study;
No quantifiable motor threshold such that TMS dosage cannot be accurately determined