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TMS for Symptom Reduction in Schizophrenia

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2016 by University of Maryland
Sponsor:
Information provided by (Responsible Party):
L. Elliot Hong, University of Maryland
ClinicalTrials.gov Identifier:
NCT02916810
First received: June 28, 2016
Last updated: September 23, 2016
Last verified: September 2016
  Purpose
Major psychotic symptoms such as auditory hallucination (AH) are main features of schizophrenia and other psychotic disorders, resulting in severe social and clinical dysfunction. However, these symptoms are sufficiently unresponsive to antipsychotic medications in a substantial portion of patients. Neuroimaging studies suggest that aberrant activities at specific brain regions such as frontal areas, sensory areas and language-related areas are related to these symptoms. Transcranial magnetic stimulation (TMS) provides a non-invasive means for altering brain electrical neural activity. TMS has been used in a wide range of clinical research especially in neurology and psychiatry. There are preliminary treatments of psychosis and AH using TMS but results are inconsistent. The high inter-subject variability limits the efficacy of TMS treatment for schizophrenia patients. The investigators aim to develop a TMS treatment method with a functional MRI-defined treatment target area, where the TMS target is individually identified to maximize the TMS effects. If the current target-identification successfully identified effective TMS target individually, the treatment efficacy could be significant improved and more patients will benefit from TMS treatment.

Condition Intervention
Schizophrenia and Related Disorders
Device: Active rTMS stimulation
Device: Sham rTMS stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Official Title: TMS for Symptom Reduction in Schizophrenia

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Clinician's Questionnaire for Auditory Hallucinations (CQAH) is used to evaluate the treatment effect of rTMS on auditory hallucination in schizophrenia. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The study will test whether the rTMS stimulations reduce auditory hallucination of schizophrenia after the last rTMS treatment session. The CQAH will be used by an clinician to evaluate the auditory hallucination severity of schizophrenia patients before and after the rTMS series.


Secondary Outcome Measures:
  • Electroencephalogram (EEG) is used to evaluate the brain electrical activities that are corresponding to the treatment effect on auditory hallucination. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The EEG recordings will be done before and after the rTMS series.

  • Functional magnetic resonance imaging (fMRI) is used to evaluate the brain activities that are corresponding to the treatment effect on auditory hallucination. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The fMRI scans will be done before and after the rTMS series.


Estimated Enrollment: 130
Study Start Date: October 2016
Estimated Study Completion Date: July 2021
Estimated Primary Completion Date: July 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active rTMS stimulation
Real active rTMS stimulation.
Device: Active rTMS stimulation
Multiple trains of active transcranial magnetic stimulation in a day, for multiple days.
Sham Comparator: Sham rTMS stimulation
Sham repetitive TMS stimulation.
Device: Sham rTMS stimulation
Multiple trains of sham transcranial magnetic stimulation in a day, for multiple days.

  Eligibility

Ages Eligible for Study:   21 Years to 62 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and Female between ages 21-62
  • Ability to give written informed consent (age 21 or above)
  • For patient participants, Evaluation to Sign Consent (ESC) 10 or greater.
  • Medication stability for 4 weeks (same drugs at same dosages)

Exclusion Criteria:

  • Any history of seizures
  • Any Family history of epilepsy in first degree relatives
  • Significant alcohol or other drug use (substance dependence within 6 months or substance abuse within 1 month) other than nicotine or marijuana dependence.
  • Any major medical illnesses that may affect normal brain functioning. Examples of these conditions include, but not limited to, stroke, CNS infection or tumor, other significant brain neurological conditions.
  • Taking > 400 mg clozapine/day
  • Failed TMS screening questionnaire
  • Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth,that cannot be safely removed.
  • History of head injury with loss of consciousness over 10 minutes; history of brain surgery
  • Can not refrain from using alcohol and/or marijuana 24 hours or more & cigarette smoking half and hour or more prior to experiments.
  • Woman who is pregnant (child-bearing potential but not on contraceptive and missing menstrual period; or by self report; or by positive pregnancy test)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02916810

Contacts
Contact: Xiaoming Du, PhD 410-402-6036 xdu@mprc.umaryland.edu
Contact: Dawn Detamore 410-402-6820 ddetamor@mprc.umaryland.edu

Locations
United States, Maryland
University of Maryland, Baltimore Not yet recruiting
Baltimore, Maryland, United States, 21228
Contact: Xiaoming Du, PhD    410-402-6036    xdu@mprc.umaryland.edu   
Contact: Dawn Detamore    410-402-6820    ddetamor@mprc.umaryland.edu   
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: L Elliot Hong, MD University of Maryland
  More Information

Responsible Party: L. Elliot Hong, Professsor, University of Maryland
ClinicalTrials.gov Identifier: NCT02916810     History of Changes
Other Study ID Numbers: HP-00070464 
Study First Received: June 28, 2016
Last Updated: September 23, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University of Maryland:
transcranial magnetic stimulation
schizophrenia
MRI

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 27, 2016