NCT03220438

Brief Summary

The major goal is to determine if Transcranial magnetic stimulation (TMS) enhances visual plasticity in schizophrenia. TMS sessions (sham/placebo and real TMS) will be conducted before two MRI scans with two weeks in-between to assess whether TMS stimulation to the visual cortex will enhance visual plasticity in patients with schizophrenia-spectrum disorders. This project may provide a better understanding of the underlying neurobiological mechanisms responsible for learning and memory deficits in schizophrenia.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 18, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

September 27, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2019

Completed
5.8 years until next milestone

Results Posted

Study results publicly available

April 18, 2025

Completed
Last Updated

April 18, 2025

Status Verified

April 1, 2025

Enrollment Period

1.8 years

First QC Date

July 14, 2017

Results QC Date

March 10, 2023

Last Update Submit

April 17, 2025

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • fMRI Blood Oxygenation Level Dependent (BOLD) Response of Visual Plasticity

    fMRI BOLD response in visual cortex, during visual stimulation (0.9 Hz) before and after high frequency visual stimulation (9 Hz).

    ~1 hour

Secondary Outcomes (1)

  • Magnetic Resonance Spectroscopy (MRS) Assessment of Glutamate

    ~1 hour

Study Arms (2)

TMS

ACTIVE COMPARATOR

rTMS

Device: Transcranial Magnetic Stimulation

Sham TMS

SHAM COMPARATOR

A sham coil will be used. This condition controls for the auditory artifacts induced by rTMS.

Device: Transcranial Magnetic Stimulation

Interventions

Transcranial Magnetic StimulationDEVICE

Transcranial Magnetic Stimulation

Sham TMSTMS

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age: 18-65,
  • no neurological illness, head trauma, or major medical illness,
  • not pregnant or nursing,
  • no contraindication for TMS or MRI scanning,
  • no current substance abuse/dependence.
  • Healthy controls will have no DSM-5 diagnosis and no first-degree relatives with a psychotic disorder.
  • DSM-5 diagnosis of schizophreniform, schizophrenia or schizoaffective and competent to sign an informed consent,
  • not currently taking other medications that affects brain structure (e.g. steroids),
  • less than 12 months antipsychotic exposure and on the same psychotropic medications for 4 weeks prior to study,
  • not be taking clozapine (due to its effects on NMDA receptors and increase of seizure threshold),
  • clinically stable (i.e. no change in psychotic symptoms for at least 4 weeks).

You may not qualify if:

  • age outside of 18-65,
  • neurological illness, head trauma, or major medical illness,
  • pregnant or nursing,
  • contraindication for TMS or MRI scanning,
  • current substance abuse/dependence,
  • currently taking medications that affects brain structure (e.g. steroids).
  • Healthy controls with a DSM-5 diagnosis and/or a first-degree relative with a psychotic disorder. Participants with schizophrenia that are not competent to sign an informed consent, have more than 12 months antipsychotic exposure, not on the same psychotropic medications for 4 weeks prior to study, taking clozapine, and not clinically stable (i.e.a change in psychotic symptoms for at least 4 weeks).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland

Baltimore, Maryland, 21228, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Limitations and Caveats

Early termination leading to small numbers unable to statistically analyze.

Results Point of Contact

Title
Dr Laura Rowland
Organization
University of Maryland Baltimore
lrowland@som.umaryland.edu
410-402-6073

Study Officials

  • Laura M Rowland, PhD

    University of Maryland, Baltimore

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 14, 2017

First Posted

July 18, 2017

Study Start

September 27, 2017

Primary Completion

July 16, 2019

Study Completion

July 16, 2019

Last Updated

April 18, 2025

Results First Posted

April 18, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)