NCT04548622

Brief Summary

The primary purpose of this study was to conduct fMRI neuroimaging studies prior to and subsequent to the rTMS intervention. The intent was to ascertain changes in regional brain activation and connectivity that most robustly predict level of improvement in auditory hallucinations elicited by bilateral rTMS as assessed by the primary outcome variables.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started Sep 2012

Typical duration for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
terminated

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

September 1, 2012

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 14, 2020

Completed
2 months until next milestone

Results Posted

Study results publicly available

October 30, 2020

Completed
Last Updated

October 30, 2020

Status Verified

October 1, 2020

Enrollment Period

4.1 years

First QC Date

September 4, 2020

Results QC Date

September 14, 2020

Last Update Submit

October 8, 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)

  • PANSS Composite Positive Symptoms Hallucination Score

    The Positive and Negative Syndrome Scale (PANSS) is a medical scale used for measuring symptom severity of patients with schizophrenia.The PANSS positive symptoms hallucinication score has a range of 1-7. Higher scores indicate more severe positive symptoms in patients with schizophrenia.

    baseline to 4 weeks

  • PANSS Composite Negative Symptom Scale

    The Positive and Negative Syndrome Scale (PANSS) is a medical scale used for measuring symptom severity of patients with schizophrenia.The PANSS negative scale has 7 Items, with a minimum score of 7 and a maximum score of 49. Higher scores indicate more severe negative symptoms in patients with schizophrenia.

    baseline to 4 weeks

  • PANSS Total Score

    The Positive and Negative Syndrome Scale (PANSS) is a medical scale used for measuring symptom severity of patients with schizophrenia.The PANSS total score has a minimum score of 30 and a maximum score of 210. Higher scores indicate more severe symptoms in patients with schizophrenia.

    baseline to 4 weeks

Study Arms (1)

Non-randomized bilateral rTMS

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

Interventions

Magstim Rapid 2 system triggering Magstim Super Rapid systemDEVICE

Week 1 treatment includes rTMS for 5 sessions to both the left and 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.

Non-randomized bilateral rTMS

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

Results Point of Contact

Title
Dr. Philip R. Corlett PhD
Organization
Yale University Department of Psychiatry
philip.corlett@yale.edu
(203) 974-7866

Study Officials

  • Philip Corlett, PhD

    Yale University Department of Psychiatry

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2020

First Posted

September 14, 2020

Study Start

September 1, 2012

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

October 30, 2020

Results First Posted

October 30, 2020

Record last verified: 2020-10

Locations

US(1)