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Trial record 31 of 3310 for:    schizophrenia

TMS for Symptom Reduction in Schizophrenia

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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

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.

Condition or disease Intervention/treatment Phase
Schizophrenia and Related Disorders Device: Active rTMS stimulation Device: Sham rTMS stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Official Title: TMS for Symptom Reduction in Schizophrenia
Actual Study Start Date : October 2016
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   21 Years to 62 Years   (Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02916810


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

Locations
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United States, Maryland
University of Maryland, Baltimore 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, Baltimore
Investigators
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Principal Investigator: L E Hong, MD University of Maryland, Baltimore

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Responsible Party: L. Elliot Hong, Professsor, University of Maryland, Baltimore
ClinicalTrials.gov Identifier: NCT02916810     History of Changes
Other Study ID Numbers: HP-00070464
First Posted: September 27, 2016    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by L. Elliot Hong, University of Maryland, Baltimore:
transcranial magnetic stimulation
schizophrenia
MRI
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders