Transcranial Magnetic Stimulation for the Treatment of Auditory Hallucinations in Schizophrenia

Schizophrenia Clinical Trial

Official title:

Functional Targeting of Transcranial Magnetic Stimulation for the Treatment of Refractory Auditory Hallucinations in Schizophrenia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01595503
• Other study ID #: HUM00046254
• Status: Terminated
• Phase: N/A
• Start date: May 2011
• Est. completion date: August 2012

Study information

• Verified date: November 2021
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Hallucinations
• Schizophrenia

Intervention

Procedure:
• rTMS with fMRI-based targeting
Inhibitory (low frequency) 1-Hz rTMS will be applied to the secondary auditory cortex during 10 daily 20-minute treatment sessions. An fMRI scan combined with a language task will be used to localize the secondary auditory cortex, followed by neuronavigation to identify the scalp location overlying the targeted cortex.
• rTMS with landmark-based targeting
Inhibitory (low frequency) 1-Hz rTMS will be applied over the left temporoparietal cortex (TPC) during 10 daily 20-minute treatment sessions, with the stimulating coil located midway between the left temporal (T3) and parietal (P3) scalp landmarks, using the International 10-20 system for EEG.

Locations

Country	Name	City	State
United States	University of Michigan Department of Psychiatry Depression Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Severity of Auditory Hallucinations	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.	Two weeks