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Clinical Trials/NCT03220438
NCT03220438TerminatedNot Applicable

Testing TMS Enhancement of Visual Plasticity in Schizophrenia

University of Maryland, Baltimore2 sites in 1 country17 target enrollmentStarted: September 27, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
17
Locations
2
Primary Endpoint
fMRI Blood Oxygenation Level Dependent (BOLD) Response of Visual Plasticity

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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).

Outcomes

Primary Outcomes

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

Time Frame: ~1 hour

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

Secondary Outcomes

  • Magnetic Resonance Spectroscopy (MRS) Assessment of Glutamate(~1 hour)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Laura Rowland

Associate Professor

University of Maryland, Baltimore

Study Sites (2)

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