Back to results

TMS for Symptom Reduction in Schizophrenia

Primary Purpose

Schizophrenia and Related Disorders

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Active rTMS stimulation

Sham rTMS stimulation

About this trial

This is an interventional other trial for Schizophrenia and Related Disorders focused on measuring transcranial magnetic stimulation, schizophrenia, MRI

Eligibility Criteria

21 Years - 62 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

University of Maryland, BaltimoreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active rTMS stimulation

Sham rTMS stimulation

Arm Description

Real active rTMS stimulation.

Sham repetitive TMS stimulation.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT02916810

First Posted

June 28, 2016

Last Updated

March 21, 2023

Sponsor

University of Maryland, Baltimore

1. Study Identification

Unique Protocol Identification Number

NCT02916810

Brief Title

TMS for Symptom Reduction in Schizophrenia

Official Title

TMS for Symptom Reduction in Schizophrenia

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 2016 (Actual)

Primary Completion Date

July 2025 (Anticipated)

Study Completion Date

July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Maryland, Baltimore

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia and Related Disorders

Keywords

transcranial magnetic stimulation, schizophrenia, MRI

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active rTMS stimulation

Arm Type

Active Comparator

Arm Description

Real active rTMS stimulation.

Arm Title

Sham rTMS stimulation

Arm Type

Sham Comparator

Arm Description

Sham repetitive TMS stimulation.

Intervention Type

Device

Intervention Name(s)

Active rTMS stimulation

Intervention Description

Multiple trains of active transcranial magnetic stimulation in a day, for multiple days.

Intervention Type

Device

Intervention Name(s)

Sham rTMS stimulation

Intervention Description

Multiple trains of sham transcranial magnetic stimulation in a day, for multiple days.

Primary Outcome Measure Information:

Title

Clinician's Questionnaire for Auditory Hallucinations (CQAH) is used to evaluate the treatment effect of rTMS on auditory hallucination in schizophrenia.

Description

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Electroencephalogram (EEG) is used to evaluate the brain electrical activities that are corresponding to the treatment effect on auditory hallucination.

Description

The EEG recordings will be done before, during, and after the rTMS series.

Time Frame

8 weeks

Title

Functional magnetic resonance imaging (fMRI) is used to evaluate the brain activities that are corresponding to the treatment effect on auditory hallucination.

Description

The fMRI scans will be done before, during, and after the rTMS series.

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

62 Years

Accepts Healthy Volunteers

Eligibility 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiaoming Du, PhD

Phone

410-402-6036

xdu@mprc.umaryland.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Dawn Detamore

Phone

410-402-6820

ddetamor@mprc.umaryland.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

L E Hong, MD

Organizational Affiliation

University of Maryland, Baltimore

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Maryland, Baltimore

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21228

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiaoming Du, PhD

Phone

410-402-6036

xdu@mprc.umaryland.edu

First Name & Middle Initial & Last Name & Degree

Dawn Detamore

Phone

410-402-6820

ddetamor@mprc.umaryland.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

TMS for Symptom Reduction in Schizophrenia

We'll reach out to this number within 24 hrs