TMS for Symptom Reduction in Schizophrenia

Schizophrenia and Related Disorders Clinical Trial

Official title:

TMS for Symptom Reduction in Schizophrenia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02916810
• Other study ID #: HP-00070464
• Status: Recruiting
• Phase: N/A
• Start date: October 2016
• Est. completion date: July 2025

Study information

• Verified date: October 2022
• Source: University of Maryland, Baltimore
• Contact: Xiaoming Du, PhD
• Phone: 410-402-6036
• Email: xdu[@]mprc.umaryland.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To test the hypothesis that functionally navigated repetitive TMS stimulations to the prefrontal cortex (PFC) modulate aberrant cortical electrical activities at PFC circuitry. The TMS location of the PFC site will be individually localized by the symptom-related functional connectivity between PFC and symptom related areas (such as the auditory and language processing cortex). The investigators predict that such modulation will correct abnormal activities in patients with schizophrenia, reduce symptoms, especially auditory hallucination, and improve working memory/sustained attention performance.

Description:

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. The investigators 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 62 Years

Eligibility

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)

Related Conditions & MeSH terms

• Schizophrenia
• Schizophrenia and Related Disorders

Intervention

Device:
• Active rTMS stimulation
Multiple trains of active transcranial magnetic stimulation in a day, for multiple days.
• Sham rTMS stimulation
Multiple trains of sham transcranial magnetic stimulation in a day, for multiple days.

Locations

Country	Name	City	State
United States	University of Maryland, Baltimore	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician's Questionnaire for Auditory Hallucinations (CQAH) is used to evaluate the treatment effect of rTMS on auditory hallucination in schizophrenia.	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, during, and after the rTMS series.	8 weeks
Secondary	Electroencephalogram (EEG) is used to evaluate the brain electrical activities that are corresponding to the treatment effect on auditory hallucination.	The EEG recordings will be done before, during, and after the rTMS series.	8 weeks
Secondary	Functional magnetic resonance imaging (fMRI) is used to evaluate the brain activities that are corresponding to the treatment effect on auditory hallucination.	The fMRI scans will be done before, during, and after the rTMS series.	8 weeks