NCT00567281

Brief Summary

This trial is designed to determine if administering repetitive transcranial magnetic stimulation (rTMS) simultaneously to two sites in the temporal lobes, one on the left and one on the right, produces greater improvements in "voices" and other symptoms of schizophrenia compared to rTMS given to just one site in the temporal lobes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Oct 2007

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 4, 2007

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

September 17, 2020

Status Verified

September 1, 2020

Enrollment Period

4.9 years

First QC Date

December 3, 2007

Last Update Submit

September 14, 2020

Conditions

Schizophrenia

Keywords

Schizoaffective disorderAuditory HallucinationsVoicesRepetitive Transcranial Magnetic StimulationrTMSWernicke's AreaMiddle Temporal CortexPersistent Auditory HallucinationsPreviously Participated in "Parent" rTMS Protocol

Outcome Measures

Primary Outcomes (3)

  • Hallucination change score

    Measured at every week over a total 4 weeks

  • Clinical Global Improvement Scale

    Measured at every week over a total of 4 weeks

  • Frequency subscale of Auditory Hallucinations Rating Scale

    Measured at baseline and every week over a total of 4 weeks

Secondary Outcomes (5)

  • Summed scores of Auditory Hallucination Rating Scale

    Measured at baseline and every week over a total of 4 weeks

  • PANSS composite positive symptoms scale

    Measured at baseline and every week over a total of 4 weeks

  • PANSS composite negative symptom scale

    Measured at baseline and every week over a total of 4 weeks

  • PANSS total score

    Measured at baseline and every week over a total of 4 weeks

  • California Verbal Learning Test (CVLT)

    Measured at baseline and every week over a total of 4 weeks

Study Arms (2)

1

EXPERIMENTAL

Active bilateral rTMS to left/right Wernicke's area and opposite side middle temporal gyrus

Device: Magstim Rapid 2 system triggering Magstim Super Rapid system

2

ACTIVE COMPARATOR

Active rTMS to left/right Wernicke's region plus sham rTMS to opposite hemisphere middle temporal cortex

Device: Magstim Rapid-2 system triggering Magstim Super Rapid system

Interventions

Magstim Rapid 2 system triggering Magstim Super Rapid systemDEVICE

Week 1 treatment includes rTMS for 5 sessions to either to left or right Wernicke's area (BA22) synchronous with rTMS to opposite hemisphere middle temporal cortex (BA21). Week 2 treatment includes rTMS given for 5 sessions with positions reversed (e.g., if Wernicke's stimulation was on the left during Week 1, position of rTMS will switch to the right side during Week 2 and vice-versa). As in Week 1, active rTMS will also be given synchronously to the opposite hemisphere middle temporal cortex. Weeks 3 and 4 include 10 stimulation sessions to the configuration of sites producing greater improvement in comparing results of Week 1 and Week 2. rTMS for each stimulation session will be given at 1-Hertz (once per second) for 16 minutes without interruption.

1
Magstim Rapid-2 system triggering Magstim Super Rapid systemDEVICE

Week 1 includes repetitive rTMS for 5 sessions to either to left or right Wernicke's area (BA22) synchronous with sham rTMS to opposite hemisphere middle temporal cortex (BA21). Week 2 includes rTMS given for 5 sessions with positions reversed (e.g., if Wernicke's stimulation was on the left during Week 1, position of rTMS will switch to the right side during Week 2 and vice-versa). As in Week 1, sham rTMS will also be given synchronously to the opposite hemisphere middle temporal cortex. Weeks 3 and 4 include 10 stimulation sessions to the configuration of sites producing greater improvement in comparing results of Week 1 and Week 2. rTMS for each stimulation session will be given at 1-Hertz (once per second) for 16 minutes without interruption.

2

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Previously enrolled in our "parent" rTMS trial with passage of at least six months since last received active rTMS

You may not qualify if:

  • Active substance abuse or alcohol abuse
  • Pregnancy
  • Dose or type of psychiatric medication changed within the 4 weeks prior to study entry
  • Recent head trauma, seizures, or significant unstable medical condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry, Yale School of Medicine

New Haven, Connecticut, 06519, United States

Location

Related Publications (4)

  • 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: 15936729BACKGROUND

  • Hoffman RE, Boutros NN, Hu S, Berman RM, Krystal JH, Charney DS. Transcranial magnetic stimulation and auditory hallucinations in schizophrenia. Lancet. 2000 Mar 25;355(9209):1073-5. doi: 10.1016/S0140-6736(00)02043-2.

    PMID: 10744097BACKGROUND

  • Hoffman RE, Hampson M, Wu K, Anderson AW, Gore JC, Buchanan RJ, Constable RT, Hawkins KA, Sahay N, Krystal JH. Probing the pathophysiology of auditory/verbal hallucinations by combining functional magnetic resonance imaging and transcranial magnetic stimulation. Cereb Cortex. 2007 Nov;17(11):2733-43. doi: 10.1093/cercor/bhl183. Epub 2007 Feb 13.

    PMID: 17298962BACKGROUND

  • Hoffman RE, Anderson AW, Varanko M, Gore JC, Hampson M. Time course of regional brain activation associated with onset of auditory/verbal hallucinations. Br J Psychiatry. 2008 Nov;193(5):424-5. doi: 10.1192/bjp.bp.107.040501.

    PMID: 18978327BACKGROUND

Related Links

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersHallucinations

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ralph Hoffman, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2007

First Posted

December 4, 2007

Study Start

October 1, 2007

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

September 17, 2020

Record last verified: 2020-09

Locations

US(1)