NCT00042159

Brief Summary

This study will evaluate the long-term effects of repetitive transcranial magnetic stimulation (rTMS) in patients with auditory hallucinations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Jul 2002

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

July 1, 2002

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 26, 2002

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2003

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
Last Updated

August 6, 2013

Status Verified

August 1, 2013

Enrollment Period

1 year

First QC Date

July 24, 2002

Last Update Submit

August 2, 2013

Conditions

Keywords

Auditory hallucinations (voices)

Outcome Measures

Primary Outcomes (1)

  • Hallucination Change Score

    2 weeks

Secondary Outcomes (3)

  • Total AHRS score

    2 weeks

  • CGI

    2 weeks

  • Frequency subscale of AHRS

    2 weeks

Interventions

1 Hertz stimulation for 16 minutes per day at 90% motor threshold, 5 sessions each to the two primary cortical targets

Eligibility Criteria

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

You may qualify if:

  • Have persistent auditory hallucinations

You may not qualify if:

  • History of neurological disorder
  • Serious, unstable medical conditions (persons with hypertension or diabetes mellitus may enroll if these conditions are treated and stable)
  • Active drug or alcohol abuse (persons may enroll if they have a history of drug or alcohol abuse provided that they do not use these substances at least 4 weeks prior to study initiation)
  • History of seizures unrelated to drug withdrawal
  • Estimated IQ less than 80
  • Have a sibling or parent with epilepsy
  • Disorganized thought process or intellectual impairment that inhibits the ability to give an informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale-New Haven Psychiatric Hospital

New Haven, Connecticut, 06519, United States

Location

Related Publications (3)

  • 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, Hawkins KA, Gueorguieva R, Boutros NN, Rachid F, Carroll K, Krystal JH. Transcranial magnetic stimulation of left temporoparietal cortex and medication-resistant auditory hallucinations. Arch Gen Psychiatry. 2003 Jan;60(1):49-56. doi: 10.1001/archpsyc.60.1.49.

    PMID: 12511172BACKGROUND
  • 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.

Related Links

MeSH Terms

Conditions

SchizophreniaHallucinations

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 24, 2002

First Posted

July 26, 2002

Study Start

July 1, 2002

Primary Completion

July 1, 2003

Study Completion

June 1, 2004

Last Updated

August 6, 2013

Record last verified: 2013-08

Locations