Purpose

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

Eligibility

Eligible Ages
Between 21 Years and 62 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
Double (Participant, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

University of Maryland, Baltimore
Baltimore, Maryland 21228
Contact:
Xiaoming Du, PhD
410-402-6036
xdu@mprc.umaryland.edu

More Details

NCT ID
NCT02916810
Status
Recruiting
Sponsor
University of Maryland, Baltimore

Study Contact

Xiaoming Du, PhD
410-402-6036
xdu@mprc.umaryland.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.