TMS Enhancement of Visual Plasticity in Schizophrenia

• Sponsor: University of Maryland, Baltimore (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03220438
• Collaborator: (none)
• Enrollment: 17
• Location: 1
• Arms: 2
• Actual Duration (Months): 21.6
• Patients Per Site Per Month: 0.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Device: Transcranial Magnetic Stimulation	N/A

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
• Actual Enrollment: 17 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: Testing TMS Enhancement of Visual Plasticity in Schizophrenia
• Actual Study Start Date: Sep 27, 2017
• Actual Primary Completion Date: Jul 16, 2019
• Actual Study Completion Date: Jul 16, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: TMS rTMS	Device: Transcranial Magnetic Stimulation; Transcranial Magnetic Stimulation
Sham Comparator: Sham TMS A sham coil will be used. This condition controls for the auditory artifacts induced by rTMS.	Device: Transcranial Magnetic Stimulation; Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcome Measures

1. fMRI BOLD response of visual plasticity [4 hours]

   fMRI BOLD response of visual plasticity

Secondary Outcome Measures

1. MRS assessment of glutamate [4 hours]

   occipital cortical glutamate levels

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Maryland	Baltimore	Maryland	United States	21228

Sponsors and Collaborators

• University of Maryland, Baltimore

Investigators

• Principal Investigator: Laura M Rowland, PhD, University of Maryland, Baltimore

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Laura Rowland, Associate Professor, University of Maryland, Baltimore
• ClinicalTrials.gov Identifier: NCT03220438
• Other Study ID Numbers: HP-00072640
• First Posted: Jul 18, 2017
• Last Update Posted: Sep 2, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Schizophrenia

Study Results

No Results Posted as of Sep 2, 2021