Transcranial Magnetic Stimulation for the Treatment of Auditory Hallucinations in Schizophrenia

NCT01595503 | Terminated Results

• 1 other identifier: HUM00046254
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

Schizophrenia, auditory hallucination

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

fMRI-based targeting

EXPERIMENTAL

Procedure: rTMS with fMRI-based targeting

landmark-based targeting

ACTIVE COMPARATOR

Procedure: rTMS with landmark-based targeting

Interventions

rTMS with fMRI-based targeting PROCEDURE

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.

fMRI-based targeting

rTMS with landmark-based targeting PROCEDURE

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.

landmark-based targeting

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Department of Psychiatry Depression Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Schizophrenia; Hallucinations

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Results Point of Contact

• Title: stephan taylor
• Organization: University of Michigan

sftaylor@umich.edu

7349364955

Study Officials

• Stephan F Taylor, M.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: May 8, 2012
• First Posted: May 10, 2012
• Study Start: May 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: December 8, 2021
• Results First Posted: December 8, 2021

Record last verified: 2021-11

Locations

US (1)