search
Back to results

Transcranial Magnetic Stimulation for the Treatment of Auditory Hallucinations in Schizophrenia

Primary Purpose

Schizophrenia

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
rTMS with fMRI-based targeting
rTMS with landmark-based targeting
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, auditory hallucination

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Michigan Department of Psychiatry Depression Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

fMRI-based targeting

landmark-based targeting

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 8, 2012
Last Updated
November 12, 2021
Sponsor
University of Michigan
search

1. Study Identification

Unique Protocol Identification Number
NCT01595503
Brief Title
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

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Terminated
Why Stopped
Insufficient recruitment
Study Start Date
May 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, auditory hallucination

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fMRI-based targeting
Arm Type
Experimental
Arm Title
landmark-based targeting
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
rTMS with fMRI-based targeting
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
rTMS with landmark-based targeting
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Severity of Auditory Hallucinations
Description
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.
Time Frame
Two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan F Taylor, M.D.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Department of Psychiatry Depression Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Transcranial Magnetic Stimulation for the Treatment of Auditory Hallucinations in Schizophrenia

We'll reach out to this number within 24 hrs