Repetitive Transcranial Magnetic Stimulation for "Voices"

NCT00004980 | Completed Phase 2 Results DMC

• 4 other identifiers: R21MH063326YALESM-9281199/14809A5-ETPD
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

OBJECTIVES: I. Determine the effect of repetitive transcranial magnetic stimulation on treatment refractory auditory hallucinations of patients with schizophrenia.

Conditions

Schizophrenia

Keywords

neurologic and psychiatric disorders; rare disease; schizophrenia

Outcome Measures

Primary Outcomes (1)

• Hallucination Change Score (HCS) After 9 Active/Sham rTMS Sessions

  Change in hallucination severity relative to baseline with scores ranging 1 in unit intervals to 20 anchored as follows: 0=hallucinations stopped, 10=no change, 20=hallucinations twice as severe as baseline

  After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)

Secondary Outcomes (3)

• Change From Baseline in Hallucination Frequency After 9 Active/Shame rTMS Sessions

  After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)

• Clinical Global Improvement (CGI) Scale After 9 Active/Shame rTMS Sessions

  After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)

• Responder Status

  After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)

Study Arms (2)

active rTMS

EXPERIMENTAL

1-Hz rTMS delivered to left temporoparietal cortex at 90% motor threshold for 16 minutes per session given one session per day for nine consecutive days (with the exception of weekends)

Device: repetitive transcranial magnetic stimulation (rTMS)

sham stimulation

PLACEBO COMPARATOR

Sham stimulation delivered 16 minutes per session given one session per day for nine consecutive days (with the exception of weekends)

Device: sham stimulation

Interventions

repetitive transcranial magnetic stimulation (rTMS) DEVICE

a total of 132 minutes of stimulation at one hertz, motor threshold set at 80%, delivered to TP3 scalp site

Also known as: MATSTIM SUPER RAPID

active rTMS

sham stimulation DEVICE

132 minutes of stimulation given at 80% motor threshold with coil tilted "single wing" 45 degrees away from scalp deliverd to TP3 site

Also known as: MAGSTIM SUPER RAPID

sham stimulation

Eligibility Criteria

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

You may qualify if:

• Diagnosis of schizophrenia or schizoaffective disorder based on DSM-IV version of SCID
• Auditory hallucinations of spoken speech occurring at least 5 times per day where subject able to discern verbal content
• Right-handed
• At least 4 weeks on stable antipsychotic medication

You may not qualify if:

• history of seizure (unless due to drug withdrawal or medication that is no longer prescribed)
• history of epilepsy in first degree relatives
• estimated IQ less than 80
• unable to provide informed consent
• significant unstable medical condition
• current treatment with clozapine or bupropion
• cochlear implants or other metal in the head (surgical, etc.)
• history of cardiac arrhythmia
• cardiac pacemaker
• active drug or alcohol abuse within prior 6 weeks
• pregnancy

Sponsors & Collaborators

• Yale University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06520-8099, United States

Location

Related Publications (1)

• Hoffman RE, Gueorguieva R, Hawkins KA, Varanko M, Boutros NN, Wu YT, Carroll K, Krystal JH. Temporoparietal transcranial magnetic stimulation for auditory hallucinations: safety, efficacy and moderators in a fifty patient sample. Biol Psychiatry. 2005 Jul 15;58(2):97-104. doi: 10.1016/j.biopsych.2005.03.041.

  PMID: 15936729 RESULT

Related Links

• Click here for the Yale School of Medicine Web site describing current, on-going rTMS trial for auditory hallucinations

MeSH Terms

Conditions

Schizophrenia; Neurologic Manifestations; Mental Disorders; Rare Diseases

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Results Point of Contact

• Title: Ralph Hoffman
• Organization: Yale University School of Medicine

ralph.hoffman@yale.edu

203-688-9734

Study Officials

• Ralph Hoffman

  Yale University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2000
• First Posted: March 13, 2000
• Study Start: December 1, 1999
• Primary Completion: January 1, 2005
• Study Completion: June 1, 2005
• Last Updated: August 7, 2013
• Results First Posted: July 9, 2012

Record last verified: 2013-08

Locations

US (1)