SchizophreniaNCT03220438

TMS Enhancement of Visual Plasticity in Schizophrenia

A study testing Transcranial Magnetic Stimulation in people with Schizophrenia, run by University of Maryland, Baltimore at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Schizophrenia
What is being tested?: Transcranial Magnetic Stimulation
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 17 participants
Where: 1 siteUnited States
Study dates: 27 Sep 2017to 16 Jul 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

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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).

Who cannot join

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).

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Maryland
Baltimore, Maryland, 21228

Other trials in United States

About this study

Official title: Testing TMS Enhancement of Visual Plasticity in Schizophrenia

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.

Read the 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
Being tested: Transcranial Magnetic Stimulation
Medical subject headings: Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transcranial Magnetic StimulationDevice
Transcranial Magnetic Stimulation

Study groups in NCT03220438
Study group	Role	What they receive
TMS	Active comparator	rTMS Receives: Device: Transcranial Magnetic Stimulation
Sham TMS	Sham comparator	A sham coil will be used. This condition controls for the auditory artifacts induced by rTMS. Receives: Device: Transcranial Magnetic Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: ~1 hour

Secondary outcomes (1)

Magnetic Resonance Spectroscopy (MRS) Assessment of Glutamate
MRS was used to obtain occipital cortical glutamate levels (active, sham). Levels reflect institutional units, as is standard for the field.
Measured: ~1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Sep 201716 Jul 2019

First posted18 Jul 2017
Study start27 Sep 2017
Primary completion16 Jul 2019
Study completion16 Jul 2019

Why it stopped: Principal Investigator took another position elsewhere

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SchizophreniaStudies of the same condition, open and under way.
More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03220438
Sponsor's protocol ID: HP-00072640
Status last verified: Apr 2025
First submitted: 14 Jul 2017
Last updated: 18 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Testing TMS Enhancement of Visual Plasticity in Schizophrenia
ClinicalTrials.gov ID: NCT03220438
Acronym / sponsor ID: HP-00072640
Conditions: Schizophrenia
Study type: Interventional
Recruitment status: TerminatedReason stopped: Principal Investigator took another position elsewhere
Enrolment: 17 participants (actual)
Lead sponsor: University of Maryland, BaltimoreUniversity, hospital or other
Study start: 27 Sep 2017 (actual)
Primary completion: 16 Jul 2019 (actual)
Study completion: 16 Jul 2019 (actual)
First posted: 18 Jul 2017 (actual)
Results: Posted 18 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
TMS	Active comparator	Device: Transcranial Magnetic StimulationrTMS
Sham TMS	Sham comparator	Device: Transcranial Magnetic StimulationA sham coil will be used. This condition controls for the auditory artifacts induced by rTMS.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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.

Key exclusion criteria (7 listed)

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,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Transcranial Magnetic StimulationTranscranial Magnetic Stimulation	Device	Sham TMS, TMS

Primary outcome

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).

1 secondary outcome

Magnetic Resonance Spectroscopy (MRS) Assessment of Glutamate
Time frame: ~1 hour

Results and safety

Results posted to the registry on 18 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TMS (Active Then Sham)	3	3
TMS (Sham Then Active)	0	0
iTBS (Active Then Sham)	6	5
iTBA (Sham Then Active)	5	5

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

Time frame: ~1 hour. Mean (Standard Deviation). Unit: Beta values

Measure	Patient: Active TMS 10 Hz n = 1	Patient: Sham TMS n = 1	Patient: Active iTBS n = 7	Patient: Sham iTBS n = 6	Control: Active TMS 10 Hz n = 2	Control: Sham TMS n = 2	Control: Active iTBS n = 3	Control: Sham iTBS n = 3
Value	-2.95 (0)	-0.66 (0)	-0.29 (2.55)	2.57 (4.17)	-0.7 (4.33)	0.86 (2.33)	-2.44 (3.27)	2.47 (1.36)

Population analysed: 13 participants completed active and/or sham conditions for either TMS or iTBS

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were assessed during active and sham sessions, 3 hours each, for up to 2 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active TMS 10 Hz	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Sham TMS	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Active iTBS	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Sham iTBS	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Limitations and caveats (from the sponsor): Early termination leading to small numbers unable to statistically analyze.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Laura M Rowland, PhD principal investigator

University of Maryland, Baltimore

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial Magnetic Stimulation in people with Schizophrenia, run by University of Maryland, Baltimore at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

fMRI Blood Oxygenation Level Dependent (BOLD) Response of Visual Plasticity (time frame: ~1 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03220438.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.