Functional Targeting of Transcranial Magnetic Stimulation for the Treatment of Refractory Auditory Hallucinations in Schizophrenia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Schizophrenia
- Sponsor
- University of Michigan
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Change in Severity of Auditory Hallucinations
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
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.
Investigators
Stephan F. Taylor
Professor of Psychiatry
University of Michigan
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
Outcomes
Primary Outcomes
Change in Severity of Auditory Hallucinations
Time Frame: Two weeks
Hallucination Change Scale (Hoffman RE, Gueorguieva R, Hawkins KA, Varanko M, Boutros NN, Wu YT, et al. (2005): Temporoparietal transcranial magnetic stimulation for auditory hallucinations: safety, efficacy and moderators in a fifty patient sample. Biol Psychiatry. 58:97-104.) Baseline score, by definition: 10 Range: 0 (no hallucinations) to 20 (hallucinations twice as bad as baseline) Thus, a score of less than 10 means that hallucinations were reduced, whereas a score of greater than 10 means that hallucinations were increased.