Transcranial Magnetic Stimulation for the Treatment of Auditory Hallucinations in Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stephan Taylor, University of Michigan
ClinicalTrials.gov Identifier:
NCT01595503
First received: May 8, 2012
Last updated: July 15, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Schizophrenia
Procedure: rTMS with fMRI-based targeting
Procedure: rTMS with landmark-based targeting

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Functional Targeting of Transcranial Magnetic Stimulation for the Treatment of Refractory Auditory Hallucinations in Schizophrenia

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Change in severity of auditory hallucinations [ Time Frame: Baseline, one week, two weeks, 1 month, 3 months ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: May 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: fMRI-based targeting 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.
Active Comparator: landmark-based targeting Procedure: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01595503

Locations
United States, Michigan
University of Michigan Department of Psychiatry Depression Center
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Stephan F Taylor, M.D. University of Michigan
  More Information

No publications provided

Responsible Party: Stephan Taylor, Professor of Psychiatry, University of Michigan
ClinicalTrials.gov Identifier: NCT01595503     History of Changes
Other Study ID Numbers: HUM00046254
Study First Received: May 8, 2012
Last Updated: July 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Schizophrenia, auditory hallucination

Additional relevant MeSH terms:
Schizophrenia
Hallucinations
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014