Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

TMS for Symptom Reduction in Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02916810
Recruitment Status : Recruiting
First Posted : September 27, 2016
Last Update Posted : October 7, 2019
Sponsor:
Information provided by (Responsible Party):
L. Elliot Hong, University of Maryland, Baltimore

Tracking Information
First Submitted Date  ICMJE June 28, 2016
First Posted Date  ICMJE September 27, 2016
Last Update Posted Date October 7, 2019
Actual Study Start Date  ICMJE October 2016
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2016)
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 ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02916810 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2016)
  • Electroencephalogram (EEG) is used to evaluate the brain electrical activities that are corresponding to the treatment effect on auditory hallucination. [ Time Frame: 4 weeks ]
    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 ]
    The fMRI scans will be done before and after the rTMS series.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TMS for Symptom Reduction in Schizophrenia
Official Title  ICMJE TMS for Symptom Reduction in Schizophrenia
Brief Summary Neuroimaging studies suggest that aberrant activities at specific brain regions such as sensory areas and language-related areas are related to psychosis symptoms including auditory and visual hallucination, delusion, and thought disorders. Transcranial magnetic stimulation (TMS) provides a non-invasive means for altering brain electrical neural activity. TMS has been approved by FDA for treatment of depression. Other applications have not been approved but it has been used in a wide range of clinical research especially in neurology and psychiatry. Among psychotic symptoms, there are preliminary significant improvement in treatments of auditory hallucination using TMS with small samples, but those treatments are not robust in larger samples. The high inter-subject variability limits the efficacy of TMS treatment in schizophrenia patients. We aim to develop a TMS treatment method with a fMRI-defined treatment target area, where the TMS target is individually identified to maximize the TMS effects. The identification method uses both the anatomical character and its functional relationship with auditory hallucination and other psychosis symptoms. If the current target-identification successfully identified effective TMS target individually, the treatment efficacy will be significant improved and more patients will benefit from TMS treatment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Schizophrenia and Related Disorders
Intervention  ICMJE
  • Device: Active rTMS stimulation
    Multiple trains of active transcranial magnetic stimulation in a day, for multiple days.
  • Device: Sham rTMS stimulation
    Multiple trains of sham transcranial magnetic stimulation in a day, for multiple days.
Study Arms  ICMJE
  • Active Comparator: Active rTMS stimulation
    Real active rTMS stimulation.
    Intervention: Device: Active rTMS stimulation
  • Sham Comparator: Sham rTMS stimulation
    Sham repetitive TMS stimulation.
    Intervention: Device: Sham rTMS stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 23, 2016)
130
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 62 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Xiaoming Du, PhD 410-402-6036 xdu@mprc.umaryland.edu
Contact: Dawn Detamore 410-402-6820 ddetamor@mprc.umaryland.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02916810
Other Study ID Numbers  ICMJE HP-00070464
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party L. Elliot Hong, University of Maryland, Baltimore
Study Sponsor  ICMJE University of Maryland, Baltimore
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: L E Hong, MD University of Maryland, Baltimore
PRS Account University of Maryland, Baltimore
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP