SchizophreniaTIESNCT06155682
TMS for Inhibition Enhancement in Schizophrenia
A study testing repetitive transcranial magnetic stimulation (active) in people with Schizophrenia, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
This study purpose is to perform a pilot mechanistic trial repetitive transcranial magnetic stimulation (rTMS) clinical trial in 34 people with schizophrenia (Sz). The trial will evaluate whether inhibitory 1 Hertz (Hz) rTMS targeting motor cortex can increase brain inhibition reflected in a decrease in the… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- repetitive transcranial magnetic stimulation (active)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2026to Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-45 years
- Male or Female
- Able to participate in the informed consent process and provide voluntary informed consent.
- A Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) diagnosis of schizophrenia documented by the Structured Clinical Interview for DSM-5 (SCID-5)
Who cannot join
- A history of a DSM-5 substance misuse disorder (other than caffeine or tobacco or mild marijuana misuse) within the past six months; or a positive baseline urine drug screen.
- A history of a current neurological disorder (including, but not limited to Parkinson's Disease, epilepsy, or Multiple Sclerosis)
- History of head trauma resulting in unconsciousness
- Contraindications for TMS, including any history of seizure other than febrile seizure, presence of ferromagnetic metal in cranium, presence of cochlear implant, presence of deep brain stimulation (DBS) electrodes based on medical history
- Contraindications for MRI, including pacemakers or other metal in body
- Suspected DSM-5 intellectual disability based upon clinical interview and psychosocial history
Show all 12Show fewer
- Pregnancy
- Any change in type of antipsychotic medication in the last 30 days and dose in the last 14 days
- Treatment with a benzodiazepine with a dose equivalent to lorazepam 2 mg/day or greater or any anticonvulsant due to the potential of these medications to affect TMS SICI score and the efficacy of rTMS
- Prior history of treatment TMS (equivalent to 5 or more sessions of rTMS or theta-burst) in the past 6 months
- Endorsement of active suicidal ideation on the Columbia-Suicide Severity Rating Scale (version: last 30 days) reflected by "yes" response on items 3, 4, or 5 of the ideation questions and/or "yes" to any of the four suicidal behavior items (actual attempt, interrupted attempt, aborted attempt, preparatory acts/behavior)
- A score of 7 or more on the Simpson-Angus Scale of Extrapyramidal Symptoms (range 0-52 with higher scores indicating worse extrapyramidal symptoms)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jennifer Zaranski contact
United States1 site, 1 recruiting
- Recruiting
Maryland Psychiatric Research Center
Catonsville, Maryland, 21228
Stephanie M Hare, PhD, 410-402-6119, stephanie.hare@som.umaryland.edu
About this study
Official title: Cognitive and Neural Correlates of TMS Motor Intracortical Inhibition in Schizophrenia
This study purpose is to perform a pilot mechanistic trial repetitive transcranial magnetic stimulation (rTMS) clinical trial in 34 people with schizophrenia (Sz). The trial will evaluate whether inhibitory 1 Hertz (Hz) rTMS targeting motor cortex can increase brain inhibition reflected in a decrease in the short-interval intracortical inhibition (SICI) score from pre-to-post-treatment. We will also collect preliminary data on the effect of rTMS on the resting functional connectivity of the motor cortex and other brain regions and the relationship of change in SICI to change in cognitive performance
Read the detailed description
This study is a randomized double blind clinical trial being funded by the National Institute of Mental Health (NIMH). The primary aim is to estimate feasibility and tolerability of a 5-day, 1Hz rTMS intervention in 34 participants with schizophrenia. A secondary aim is to assess target engagement by investigating whether 1 Hz rTMS applied to motor cortex can enhance intracortical inhibition in participants with schizophrenia. The participants with Sz will be randomized in a 1:1 ratio to either active 1Hz rTMS or sham 1Hz rTMS. We do not necessarily anticipate a statistically significant difference between treatment groups, given our limited sample size. Rather, we are focused on generating effect size estimates that will help us determine whether and how to proceed to the next phase of research and a future R01 submission. We will explore the relationship between change in SICI score (pre-to-post-treatment) and total scores of clinical scales (Fagerstrom nicotine dependence, the brief psychiatric rating scale and the brief negative symptoms scale) and medication dose and type. We will also collect preliminary data on the effect of rTMS on the resting state functional connectivity of the motor cortex with other brain regions, and the change performance on cognitive tasks (i.e., stop signal reaction time, spatial working memory) from pre-to-post-treatment.
- Conditions
- Schizophrenia
- Being tested
- repetitive transcranial magnetic stimulation (active), repetitive transcranial magnetic stimulation (sham)
- Keywords
- TMS, brain inhibition, SICI, schizophrenia, fMRI
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive transcranial magnetic stimulation (active)Device
non-invasive active repetitive stimulation applied to the scalp surface
repetitive transcranial magnetic stimulation (sham)Device
non-invasive active repetitive stimulation applied to the scalp surface
| Study group | Role | What they receive |
|---|---|---|
| Active rTMS | Active comparator | multiple trains of active transcranial magnetic stimulation in a day (using the active TMS coil), for multiple days Receives: Device: repetitive transcranial magnetic stimulation (active) |
| sham rTMS | Sham comparator | multiple trains of sham transcranial magnetic stimulation in a day (using the sham comparator TMS coil), for multiple days Receives: Device: repetitive transcranial magnetic stimulation (sham) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in the short interval intracortical inhibition (SICI) score
At baseline, and at the end of 5 days of rTMS treatment, we will perform 24 trials of paired-pulse TMS to calculate SICI score (defined as the ratio of the evoked motor potential to the paired-pulse TMS in our SICI protocol relative to a single suprathreshold pulse). We will average across these 24 trials to get an average SICI score (both pre-TMS and post-TMS). We will calculate the change in SICI score (pre-TMS to post-TMS) for each participant.
Measured: one week
Secondary outcomes (2)
change in motor cortex functional connectivity
The measure will be collected at baseline (pre-treatment) and after week 1 (post-treatment). At each magnetic resonance imaging (MRI) scanning session, we will conduct a resting functional MRI scan. The mean of motor functional connectivity will be defined as the average connectivity between regions of interest in the motor network that is informed by our preliminary data and Research Aim 2. We will use the pre- and post- rTMS functional connectivity values to calculate change in motor functional connectivity.
Measured: one week
change in neurocognitive performance
This measure will be collected at baseline (pre-treatment) and after week 1 (post-treatment). We will also collect preliminary data on the effect of rTMS on the relationship of change in SICI to change in neurocognitive performance. Neurocognitive data will include Stop-Signal task performance, working memory performance, and total and subscale scores on the the Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery (MCCB). We will use the pre- and post- rTMS neurocognitive scores to calculate change in neurocognitive performance.
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start2 Feb 2026
- Primary completionMar 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Stephanie Hare, University of Maryland, Baltimore
- Investigators
- Stephanie Hare, PhD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06155682
- Sponsor's protocol ID
- HP-00108871
- Acronym
- TIES
- Status last verified
- Feb 2026
- First submitted
- 22 Nov 2023
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive and Neural Correlates of TMS Motor Intracortical Inhibition in Schizophrenia
- ClinicalTrials.gov ID
- NCT06155682
- Acronym / sponsor ID
- TIES / HP-00108871
- Conditions
- Schizophrenia
- Keywords
- TMS, brain inhibition, SICI, schizophrenia, fMRI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 4 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study purpose is to perform a pilot mechanistic trial repetitive transcranial magnetic stimulation (rTMS) clinical trial in 34 people with schizophrenia (Sz). The trial will evaluate whether inhibitory 1 Hertz (Hz) rTMS targeting motor cortex can increase brain inhibition reflected in a decrease in the short-interval intracortical inhibition (SICI) score from pre-to-post-treatment. We will also collect preliminary data on the effect of rTMS on the resting functional connectivity of the motor cortex and other brain regions and the relationship of change in SICI to change in cognitive performance
Detailed description
This study is a randomized double blind clinical trial being funded by the National Institute of Mental Health (NIMH). The primary aim is to estimate feasibility and tolerability of a 5-day, 1Hz rTMS intervention in 34 participants with schizophrenia. A secondary aim is to assess target engagement by investigating whether 1 Hz rTMS applied to motor cortex can enhance intracortical inhibition in participants with schizophrenia. The participants with Sz will be randomized in a 1:1 ratio to either active 1Hz rTMS or sham 1Hz rTMS. We do not necessarily anticipate a statistically significant difference between treatment groups, given our limited sample size. Rather, we are focused on generating effect size estimates that will help us determine whether and how to proceed to the next phase of research and a future R01 submission. We will explore the relationship between change in SICI score (pre-to-post-treatment) and total scores of clinical scales (Fagerstrom nicotine dependence, the brief psychiatric rating scale and the brief negative symptoms scale) and medication dose and type. We will also collect preliminary data on the effect of rTMS on the resting state functional connectivity of the motor cortex with other brain regions, and the change performance on cognitive tasks (i.e., stop signal reaction time, spatial working memory) from pre-to-post-treatment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active rTMS | Active comparator | Device: repetitive transcranial magnetic stimulation (active)multiple trains of active transcranial magnetic stimulation in a day (using the active TMS coil), for multiple days |
| sham rTMS | Sham comparator | Device: repetitive transcranial magnetic stimulation (sham)multiple trains of sham transcranial magnetic stimulation in a day (using the sham comparator TMS coil), for multiple days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-45 years
- Male or Female
- Able to participate in the informed consent process and provide voluntary informed consent.
- A Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) diagnosis of schizophrenia documented by the Structured Clinical Interview for DSM-5 (SCID-5)
Key exclusion criteria (12 listed)
- A history of a DSM-5 substance misuse disorder (other than caffeine or tobacco or mild marijuana misuse) within the past six months; or a positive baseline urine drug screen.
- A history of a current neurological disorder (including, but not limited to Parkinson's Disease, epilepsy, or Multiple Sclerosis)
- History of head trauma resulting in unconsciousness
- Contraindications for TMS, including any history of seizure other than febrile seizure, presence of ferromagnetic metal in cranium, presence of cochlear implant, presence of deep brain stimulation (DBS) electrodes based on medical history
- Contraindications for MRI, including pacemakers or other metal in body
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 |
|---|---|---|
| repetitive transcranial magnetic stimulation (active)non-invasive active repetitive stimulation applied to the scalp surface | Device | Active rTMS |
| repetitive transcranial magnetic stimulation (sham)non-invasive active repetitive stimulation applied to the scalp surface | Device | sham rTMS |
Primary outcome
The change in the short interval intracortical inhibition (SICI) score
Time frame: one week
At baseline, and at the end of 5 days of rTMS treatment, we will perform 24 trials of paired-pulse TMS to calculate SICI score (defined as the ratio of the evoked motor potential to the paired-pulse TMS in our SICI protocol relative to a single suprathreshold pulse). We will average across these 24 trials to get an average SICI score (both pre-TMS and post-TMS). We will calculate the change in SICI score (pre-TMS to post-TMS) for each participant.
2 secondary outcomes
change in motor cortex functional connectivity
Time frame: one week
change in neurocognitive performance
Time frame: one week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Maryland Psychiatric Research CenterLink provided by the sponsor.
- 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.
Jennifer Zaranski contact
Stephanie Hare, 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 repetitive transcranial magnetic stimulation (active) 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 4 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 13 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Hare, PhD (410-402-6119, stephanie.hare@som.umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in the short interval intracortical inhibition (SICI) score (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2026.