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TMS Enhancement of Visual Plasticity in Schizophrenia

Primary Purpose

Schizophrenia

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. age: 18-65,
  2. no neurological illness, head trauma, or major medical illness,
  3. not pregnant or nursing,
  4. no contraindication for TMS or MRI scanning,
  5. no current substance abuse/dependence.

Healthy controls will have no DSM-5 diagnosis and no first-degree relatives with a psychotic disorder.

Inclusion criteria for patients includes:

  1. DSM-5 diagnosis of schizophreniform, schizophrenia or schizoaffective and competent to sign an informed consent,
  2. not currently taking other medications that affects brain structure (e.g. steroids),
  3. less than 12 months antipsychotic exposure and on the same psychotropic medications for 4 weeks prior to study,
  4. not be taking clozapine (due to its effects on NMDA receptors and increase of seizure threshold),
  5. clinically stable (i.e. no change in psychotic symptoms for at least 4 weeks).

Exclusion Criteria:

  1. age outside of 18-65,
  2. neurological illness, head trauma, or major medical illness,
  3. pregnant or nursing,
  4. contraindication for TMS or MRI scanning,
  5. current substance abuse/dependence,
  6. 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).

Sites / Locations

  • University of Maryland

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

TMS

Sham TMS

Arm Description

rTMS

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

Outcomes

Primary Outcome Measures

fMRI BOLD response of visual plasticity
fMRI BOLD response of visual plasticity

Secondary Outcome Measures

MRS assessment of glutamate
occipital cortical glutamate levels

Full Information

First Posted
July 14, 2017
Last Updated
September 1, 2021
Sponsor
University of Maryland, Baltimore
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1. Study Identification

Unique Protocol Identification Number
NCT03220438
Brief Title
TMS Enhancement of Visual Plasticity in Schizophrenia
Official Title
Testing TMS Enhancement of Visual Plasticity in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
Principal Investigator took another position elsewhere
Study Start Date
September 27, 2017 (Actual)
Primary Completion Date
July 16, 2019 (Actual)
Study Completion Date
July 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Learning and memory impairments are commonly observed in schizophrenia spectrum disorders. Alterations in "long-term potentiation" (LTP), a basic mechanism underlying learning and memory, may explain this impairment. This project will assess fMRI visual plasticity, thought to reflect LTP, in participants with and without schizophrenia spectrum disorders. Previous studies have shown that visual plasticity is impaired in schizophrenia. The major goal is to determine if Transcranial magnetic stimulation (TMS) enhances visual plasticity in schizophrenia. Transcranial magnetic stimulation (TMS) provides a non-invasive means for altering brain electrical neural activity. 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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TMS
Arm Type
Active Comparator
Arm Description
rTMS
Arm Title
Sham TMS
Arm Type
Sham Comparator
Arm Description
A sham coil will be used. This condition controls for the auditory artifacts induced by rTMS.
Intervention Type
Device
Intervention Name(s)
Transcranial Magnetic Stimulation
Intervention Description
Transcranial Magnetic Stimulation
Primary Outcome Measure Information:
Title
fMRI BOLD response of visual plasticity
Description
fMRI BOLD response of visual plasticity
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
MRS assessment of glutamate
Description
occipital cortical glutamate levels
Time Frame
4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Inclusion criteria for patients includes: 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). Exclusion Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura M Rowland, PhD
Organizational Affiliation
University of Maryland, Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21228
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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TMS Enhancement of Visual Plasticity in Schizophrenia

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