TMS Enhancement of Visual Plasticity in Schizophrenia

NCT ID: NCT03220438

Last Updated: 2025-04-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-27
• Study Completion Date: 2019-07-16

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

TMS

rTMS

Group Type: ACTIVE_COMPARATOR

Transcranial Magnetic Stimulation

Intervention Type: DEVICE

Transcranial Magnetic Stimulation

Sham TMS

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

Group Type: SHAM_COMPARATOR

Transcranial Magnetic Stimulation

Intervention Type: DEVICE

Transcranial Magnetic Stimulation

Interventions

Transcranial Magnetic Stimulation

Transcranial Magnetic Stimulation

Intervention Type: DEVICE

Eligibility Criteria

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.

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Laura Rowland

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laura M Rowland, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Locations

University of Maryland

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HP-00072640

Identifier Type: -

Identifier Source: org_study_id