NCT00685321

Brief Summary

Objectives:The purpose of the study is to explore the efficacy and safety of H1-Coil deep brain rTMS in subjects with negative symptoms and cognitive deficits of schizophrenia (deficit syndrome), currently treated with atypical antipsychotics. Patient Population: The intention is to treat 45 patients diagnosed with schizophrenia, who are currently suffering mainly from negative symptoms and cognitive deficits (deficit syndrome). The patients will be of all racial, ethnic and gender categories, ranging from 18 to 65 years of age, and have PANSS negative≥21 and PANSS positive\<24. Patients will be recruited from both academic and private research centers. Structure: The study is a randomized, prospective, 8 weeks, double blind study. Blinding: The treatment administrator and the study personnel and patients will be masked to the treatment being administrated. Concurrent Control: The study group will receive active rTMS treatment and the control group will receive an inactive, sham treatment.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Jun 2008

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

2 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

May 25, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 28, 2008

Completed
4 days until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

January 5, 2012

Status Verified

January 1, 2012

Enrollment Period

4.6 years

First QC Date

May 25, 2008

Last Update Submit

January 4, 2012

Conditions

Schizophrenia

Keywords

schizophreniaTMSbrain stimulationnegative symptomsclinical improvementcognitive improvement

Outcome Measures

Primary Outcomes (1)

  • SANS

    1.5 year

Secondary Outcomes (1)

  • SOFAS

    1.5 Year

Study Arms (2)

1

EXPERIMENTAL

deep TMS treatment

Device: H1 deep TMS coil

2

SHAM COMPARATOR

inactive treatment

Device: Sham

Interventions

H1 deep TMS coilDEVICE

20 daily deep rTMS treatment

1
ShamDEVICE

inactive treatment

2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients between the ages of 18-65 (male and female), Diagnosed in the past as suffering from schizophrenia. The diagnosis will be reaffirmed according to ICD criteria.
  • Right hand dominant.
  • Scores in PANSS negative questionnaire above 21.
  • Gave informed consent for participation in the study.
  • Negative answers on safety screening questionnaire for transcranial magnetic stimulation
  • stable on the same antipsychotic medication for at least two months prior to entering the study.
  • Negative answers to all questions in the TMS safety questionnaire (attached ).

You may not qualify if:

  • Diagnosed as suffering from another axis 1 disorder .
  • Scores in PANSS positive questionnaire above 24.
  • History of epilepsy, seizure, or hot spasm.
  • History of epilepsy within first-degree relatives.
  • History of head injuries.
  • History of metal in the head (outside the mouth space).
  • History of surgery including metal implant or history of metal particles in the eye, pacemaker, or any other medical pump.
  • History of migraines.
  • History of hearing loss (not due to aging) or cochlear implants.
  • History of drug or alcohol abuse during the last year.
  • Women - Pregnancy or not using a reliable method of birth control.
  • Inability to achieve satisfying level of communication with the subject.
  • suicide attempt in the year prior to treatment or suicide risk according to a suicide questionnaire
  • Custodians.
  • Participation in another medical study during the experiment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Shalvata Mental Helath Center

Hod HaSharon, Israel

RECRUITING

Shalvata

Hod HaSharon, Israel

NOT YET RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • yechiel levkovitz, MD

    Shalvate mental health center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

liron rabani, Phd. student

CONTACT

972-97478644lironrab@clalit.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2008

First Posted

May 28, 2008

Study Start

June 1, 2008

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

January 5, 2012

Record last verified: 2012-01

Locations

IL(2)