Clinical trial NCT01595503: Transcranial Magnetic Stimulation for the Treatment of Auditory Hallucinations in Schizophrenia
Official title: Functional Targeting of Transcranial Magnetic Stimulation for the Treatment of Refractory Auditory Hallucinations in Schizophrenia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Schizophrenia
Keywords: Schizophrenia, auditory hallucination
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2012-05-10
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Severity of Auditory Hallucinations
timeFrame: Two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Department of Psychiatry Depression Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: Stephan F Taylor, M.D.
role: PRINCIPAL_INVESTIGATOR
References: