SchizophreniarTMS-EMNCT04182113
rTMS as a Probe of Episodic Memory Neurocircuitry in Schizophrenia
A study testing 1 Hz rTMS Stimulation in people with Schizophrenia, run by Indiana University at 2 sites in United States.
Trial summary
This will be a single site pilot study. 30 subjects with Early Phase Psychosis (EPP), defined as medical record documentation of the onset of clinically significant psychotic symptoms within the past ten years, will be enrolled. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- 1 Hz rTMS Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Nov 2019to 30 Jun 2022
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Between 18 and 40 years of age
- Within 10 years of illness onset as defined by entry into treatment for psychotic symptoms
- Able to give informed consent
- Willing and able to adhere to the study schedule
- Structured Clinical Interview for DSM-5 (SCID-5) diagnosis of schizophrenia
- Clinical stability defined by:
- Subjects must not have experienced an exacerbation of their illness within 4 weeks prior to randomization, leading to an intensification of psychiatric care in the opinion of the investigator. Examples of intensification of care include, but are not limited to: inpatient hospitalization, day/partial hospitalization, outpatient crisis management, or psychiatric treatment in an emergency room AND
- Antipsychotic treatment stability for at least 4 weeks prior to randomization (no change in antipsychotic dosing or addition of new antipsychotic medication)
Who cannot join
- Lifetime history of a seizure, excluding febrile seizures and those induced by substance withdrawal
- First degree relative with idiopathic epilepsy or other seizure disorder
- History of significant neurological illness
- History of head trauma as defined by a loss of consciousness or a post-concussive syndrome
- Pregnant or breast feeding
- Known intelligence quotient (IQ) < 70 based on subject report
Show all 15Show fewer
- Current acute, serious, or unstable medical conditions
- Metallic objects planted in or near the head, including implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, Transcutaneous Electrical Nerve Stimulation (TENS) unit, ventriculoperitoneal shunt, or cochlear implants
- Contraindications to Magnetic Resonance Imaging (MRI) or otherwise unable to tolerate MRI procedures
- History of electroconvulsive therapy
- Subjects taking clozapine
- Subjects who have participated in a clinical trial with any pharmacological treatment intervention for which they received study-related medication in the 4 weeks prior to randomization
- Subjects considered a high risk for suicidal acts - active suicidal ideation as determined by clinical interview OR any suicide attempt in 90 days prior to screening
- Current DSM-5 diagnosis of alcohol or drug use disorder (excluding nicotine or caffeine)
- Subjects who require concomitant treatment with prohibited medication, as specified in Attachment 2
Trial locations and contacts
2 sites in 1 country.
United States2 sites
IU Center for Neuroimaging
Indianapolis, Indiana, 46202
Prevention and Recovery Center for Early Psychosis
Indianapolis, Indiana, 46202
About this study
Official title: Repetitive Transcranial Magnetic Stimulation (rTMS) as a Probe of Episodic Memory (EM) Neurocircuitry in Schizophrenia
This will be a single site pilot study. 30 subjects with Early Phase Psychosis (EPP), defined as medical record documentation of the onset of clinically significant psychotic symptoms within the past ten years, will be enrolled. Prior to randomization (Session 1), subjects will undergo Functional Magnetic Resonance Imaging (fMRI) during Episodic Memory (EM) and Resting State (RS) paradigms. This baseline scan will also include a high-resolution structural sequence for neuronavigation purposes. Then on three separate days each occurring one-week apart, subjects will receive one session of inhibitory (1 Hertz [Hz]) Repetitive Transcranial Magnetic Stimulation (rTMS), one session of excitatory (20 Hz) rTMS, and one sham stimulation session targeting the precuneus. The order of the three interventions will be randomized. Immediately following each rTMS or sham session, subjects will undergo repeat fMRI during EM and RS paradigms. The investigators will also examine the effect of rTMS on EM performance.
Read the detailed description
In spite of existing work studying rTMS as a treatment modality in schizophrenia, there are no studies that have examined the effects of precuneus directed rTMS on either EM deficits or the neurocircuitry subserving EM in schizophrenia. It is also important to note that the vast majority of studies using rTMS in schizophrenia have examined chronic populations where confounds associated with prolonged duration of illness may be present. Early Phase Psychosis (EPP) is a desirable population to study because these individuals tend to have fewer psychiatric and physical comorbidities and less antipsychotic drug exposure, all of which are factors that may confound investigations of new treatment interventions for this illness. In light of the significant unmet medical need associated with schizophrenia and the grave clinical effect of disrupted EM in the illness, rTMS modulating the precuneus, and potentially EM circuitry, represents an unexplored and potentially novel potential treatment option.
This study proposes to combine functional magnetic resonance imaging (fMRI) with inhibitory Low Frequency (LF) (1 Hz) and excitatory High Frequency (HF) (20 Hz) rTMS protocols to interrogate the effects of rTMS targeting the precuneus on: 1) precuneus activation during EM task performance; 2) functional connectivity between the precuneus and key EM circuitry, specifically the Dorsolateral Prefrontal Cortex (DLPFC), Anterior Cingulate Cortex (ACC), and hippocampus and 3) performance during an in-scanner scene encoding and recognition EM task. This study will provide vital preliminary data on target engagement informing future clinical trials seeking to utilize rTMS to treat EM impairment in schizophrenia. This is an important population for study because if effective, rTMS may represent a novel treatment for EM deficits in schizophrenia. This study will also seek to refine the understanding of the brain circuitry that mediates the potential pro-EM effects of rTMS through the use of fMRI at baseline and following the course of rTMS administration.
- Conditions
- Schizophrenia
- Being tested
- 1 Hz rTMS Stimulation, Sham rTMS Stimulation
- Keywords
- schizophrenia, psychosis, early phase psychosis, rTMS
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 Hz rTMS StimulationDevice
Also called rTMS
rTMS is an electromagnetic device that provides non-invasive stimulation to the cortex or a sham placebo stimulation that mimics properties without stimulation.
Sham rTMS StimulationDevice
rTMS is an electromagnetic device that provides non-invasive stimulation to the cortex or a sham placebo stimulation that mimics properties without stimulation.
| Study group | Role | What they receive |
|---|---|---|
| 1 Hz rTMS Stimulation first, then 20 Hz rTMS Stimulation, then sham rTMS | Experimental | Subjects will receive one session of each: low frequency rTMS within the following stimulation parameters: Continuous 20-minute train of 1 Hz rTMS, at 120% of motor threshold (MT), for a total of 1200 pulses, high frequency rTMS within the following stimulation parameters: 20 Hz, at 120% of MT, 60 trains (1.0 second per train), 20 pulses per train, inter-train interval of 15 seconds, for a total of 1200 pulses over 16 minute, Sham stimulation session targeting the precuneus. The active and sham functions share the same acoustic properties and sham mimics cutaneous stimulation, facilitating double-blinding. Receives: Device: 1 Hz rTMS Stimulation; Device: Sham rTMS Stimulation |
| 1 Hz rTMS Stimulation first, then sham rTMS, then 20 Hz rTMS Stimulation | Experimental | Subjects will receive one session of each: low frequency rTMS within the following stimulation parameters: Continuous 20-minute train of 1 Hz rTMS, at 120% of motor threshold (MT), for a total of 1200 pulses, high frequency rTMS within the following stimulation parameters: 20 Hz, at 120% of MT, 60 trains (1.0 second per train), 20 pulses per train, inter-train interval of 15 seconds, for a total of 1200 pulses over 16 minute, Sham stimulation session targeting the precuneus. The active and sham functions share the same acoustic properties and sham mimics cutaneous stimulation, facilitating double-blinding. Receives: Device: 1 Hz rTMS Stimulation; Device: Sham rTMS Stimulation |
| 20 Hz rTMS Stimulation first, then 1 Hz rTMS Stimulation, then sham rTMS | Experimental | Subjects will receive one session of each: low frequency rTMS within the following stimulation parameters: Continuous 20-minute train of 1 Hz rTMS, at 120% of motor threshold (MT), for a total of 1200 pulses, high frequency rTMS within the following stimulation parameters: 20 Hz, at 120% of MT, 60 trains (1.0 second per train), 20 pulses per train, inter-train interval of 15 seconds, for a total of 1200 pulses over 16 minute, Sham stimulation session targeting the precuneus. The active and sham functions share the same acoustic properties and sham mimics cutaneous stimulation, facilitating double-blinding. Receives: Device: 1 Hz rTMS Stimulation; Device: Sham rTMS Stimulation |
| 20 Hz rTMS Stimulation first, then sham rTMS, then 1 Hz rTMS Stimulation | Experimental | Subjects will receive one session of each: low frequency rTMS within the following stimulation parameters: Continuous 20-minute train of 1 Hz rTMS, at 120% of motor threshold (MT), for a total of 1200 pulses, high frequency rTMS within the following stimulation parameters: 20 Hz, at 120% of MT, 60 trains (1.0 second per train), 20 pulses per train, inter-train interval of 15 seconds, for a total of 1200 pulses over 16 minute, Sham stimulation session targeting the precuneus. The active and sham functions share the same acoustic properties and sham mimics cutaneous stimulation, facilitating double-blinding. Receives: Device: 1 Hz rTMS Stimulation; Device: Sham rTMS Stimulation |
| sham rTMS first, then 1 Hz rTMS Stimulation, then 20 Hz rTMS Stimulation | Experimental | Subjects will receive one session of each: low frequency rTMS within the following stimulation parameters: Continuous 20-minute train of 1 Hz rTMS, at 120% of motor threshold (MT), for a total of 1200 pulses, high frequency rTMS within the following stimulation parameters: 20 Hz, at 120% of MT, 60 trains (1.0 second per train), 20 pulses per train, inter-train interval of 15 seconds, for a total of 1200 pulses over 16 minute, Sham stimulation session targeting the precuneus. The active and sham functions share the same acoustic properties and sham mimics cutaneous stimulation, facilitating double-blinding. Receives: Device: 1 Hz rTMS Stimulation; Device: Sham rTMS Stimulation |
| sham rTMS first, then 20 Hz rTMS Stimulation, then 1 Hz rTMS Stimulation | Experimental | Subjects will receive one session of each: low frequency rTMS within the following stimulation parameters: Continuous 20-minute train of 1 Hz rTMS, at 120% of motor threshold (MT), for a total of 1200 pulses, high frequency rTMS within the following stimulation parameters: 20 Hz, at 120% of MT, 60 trains (1.0 second per train), 20 pulses per train, inter-train interval of 15 seconds, for a total of 1200 pulses over 16 minute, Sham stimulation session targeting the precuneus. The active and sham functions share the same acoustic properties and sham mimics cutaneous stimulation, facilitating double-blinding. Receives: Device: 1 Hz rTMS Stimulation; Device: Sham rTMS Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Precuneus Functional Activation
Change in estimated beta coefficients for the Target vs. Foil contrast during scene recognition in the precuneus. Beta coefficients reflect the strength of the blood oxygen-level dependent (BOLD) signal during each condition.Target images are those previously shown to participants, and Foil images have not been previously shown, as participants indicate whether they have been shown images. A higher measure indicates that the intervention increased brain activity during recognition of previously shown scenes.
Measured: 1 day
Precuneus Functional Connectivity
Blood oxygen level dependent (BOLD) signal functional connectivity with the precuneus in the bilateral dorsolateral prefrontal cortex, hippocampus, and anterior cingulate cortex. Value is the mean Fisher's transform of the correlation of BOLD time-series in the precuneus with the BOLD time-series in other named regions. Higher values indicate greater connectivity with the precuneus following the intervention. Value of zero indicates no relationship (no connectivity). This value has no unit of measurement.
Measured: 1 day
Performance During In-scanner Episodic Memory Task
Percent accuracy (0-100%) on detecting whether an image shown during a scene recognition was among those shown during the previous five-minute session. Higher scores indicate better performance in recalling images.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start8 Nov 2019
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
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 Indiana UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All patients will receive 1 Hz rTMS, 20 Hz rTMS, and Sham rTMS, in a randomized order.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tom Hummer, Indiana University
- Investigators
- Tom Hummer, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04182113
- Sponsor's protocol ID
- 1907931487
- Acronym
- rTMS-EM
- Status last verified
- Jul 2023
- First submitted
- 28 Oct 2019
- Last updated
- 28 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation (rTMS) as a Probe of Episodic Memory (EM) Neurocircuitry in Schizophrenia
- ClinicalTrials.gov ID
- NCT04182113
- Acronym / sponsor ID
- rTMS-EM / 1907931487
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, psychosis, early phase psychosis, rTMS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 8 Nov 2019 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 2 Dec 2019 (actual)
- Results
- Posted 28 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a single site pilot study. 30 subjects with Early Phase Psychosis (EPP), defined as medical record documentation of the onset of clinically significant psychotic symptoms within the past ten years, will be enrolled. Prior to randomization (Session 1), subjects will undergo Functional Magnetic Resonance Imaging (fMRI) during Episodic Memory (EM) and Resting State (RS) paradigms. This baseline scan will also include a high-resolution structural sequence for neuronavigation purposes. Then on three separate days each occurring one-week apart, subjects will receive one session of inhibitory (1 Hertz [Hz]) Repetitive Transcranial Magnetic Stimulation (rTMS), one session of excitatory (20 Hz) rTMS, and one sham stimulation session targeting the precuneus. The order of the three interventions will be randomized. Immediately following each rTMS or sham session, subjects will undergo repeat fMRI during EM and RS paradigms. The investigators will also examine the effect of rTMS on EM performance.
Detailed description
In spite of existing work studying rTMS as a treatment modality in schizophrenia, there are no studies that have examined the effects of precuneus directed rTMS on either EM deficits or the neurocircuitry subserving EM in schizophrenia. It is also important to note that the vast majority of studies using rTMS in schizophrenia have examined chronic populations where confounds associated with prolonged duration of illness may be present. Early Phase Psychosis (EPP) is a desirable population to study because these individuals tend to have fewer psychiatric and physical comorbidities and less antipsychotic drug exposure, all of which are factors that may confound investigations of new treatment interventions for this illness. In light of the significant unmet medical need associated with schizophrenia and the grave clinical effect of disrupted EM in the illness, rTMS modulating the precuneus, and potentially EM circuitry, represents an unexplored and potentially novel potential treatment option.
This study proposes to combine functional magnetic resonance imaging (fMRI) with inhibitory Low Frequency (LF) (1 Hz) and excitatory High Frequency (HF) (20 Hz) rTMS protocols to interrogate the effects of rTMS targeting the precuneus on: 1) precuneus activation during EM task performance; 2) functional connectivity between the precuneus and key EM circuitry, specifically the Dorsolateral Prefrontal Cortex (DLPFC), Anterior Cingulate Cortex (ACC), and hippocampus and 3) performance during an in-scanner scene encoding and recognition EM task. This study will provide vital preliminary data on target engagement informing future clinical trials seeking to utilize rTMS to treat EM impairment in schizophrenia. This is an important population for study because if effective, rTMS may represent a novel treatment for EM deficits in schizophrenia. This study will also seek to refine the understanding of the brain circuitry that mediates the potential pro-EM effects of rTMS through the use of fMRI at baseline and following the course of rTMS administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- All patients will receive 1 Hz rTMS, 20 Hz rTMS, and Sham rTMS, in a randomized order.
| Arm | Type | Receives |
|---|---|---|
| 1 Hz rTMS Stimulation first, then 20 Hz rTMS Stimulation, then sham rTMS | Experimental | Device: 1 Hz rTMS Stimulation, Device: Sham rTMS StimulationSubjects will receive one session of each: low frequency rTMS within the following stimulation parameters: Continuous 20-minute train of 1 Hz rTMS, at 120% of motor threshold (MT), for a total of 1200 pulses, high frequency rTMS within the following stimulation parameters: 20 Hz, at 120% of MT, 60 trains (1.0 second per train), 20 pulses per train, inter-train interval of 15 seconds, for a total of 1200 pulses over 16 minute, Sham stimulation session targeting the precuneus. The active and sham functions share the same acoustic properties and sham mimics cutaneous stimulation, facilitating double-blinding. |
| 1 Hz rTMS Stimulation first, then sham rTMS, then 20 Hz rTMS Stimulation | Experimental | Device: 1 Hz rTMS Stimulation, Device: Sham rTMS StimulationSubjects will receive one session of each: low frequency rTMS within the following stimulation parameters: Continuous 20-minute train of 1 Hz rTMS, at 120% of motor threshold (MT), for a total of 1200 pulses, high frequency rTMS within the following stimulation parameters: 20 Hz, at 120% of MT, 60 trains (1.0 second per train), 20 pulses per train, inter-train interval of 15 seconds, for a total of 1200 pulses over 16 minute, Sham stimulation session targeting the precuneus. The active and sham functions share the same acoustic properties and sham mimics cutaneous stimulation, facilitating double-blinding. |
| 20 Hz rTMS Stimulation first, then 1 Hz rTMS Stimulation, then sham rTMS | Experimental | Device: 1 Hz rTMS Stimulation, Device: Sham rTMS StimulationSubjects will receive one session of each: low frequency rTMS within the following stimulation parameters: Continuous 20-minute train of 1 Hz rTMS, at 120% of motor threshold (MT), for a total of 1200 pulses, high frequency rTMS within the following stimulation parameters: 20 Hz, at 120% of MT, 60 trains (1.0 second per train), 20 pulses per train, inter-train interval of 15 seconds, for a total of 1200 pulses over 16 minute, Sham stimulation session targeting the precuneus. The active and sham functions share the same acoustic properties and sham mimics cutaneous stimulation, facilitating double-blinding. |
| 20 Hz rTMS Stimulation first, then sham rTMS, then 1 Hz rTMS Stimulation | Experimental | Device: 1 Hz rTMS Stimulation, Device: Sham rTMS StimulationSubjects will receive one session of each: low frequency rTMS within the following stimulation parameters: Continuous 20-minute train of 1 Hz rTMS, at 120% of motor threshold (MT), for a total of 1200 pulses, high frequency rTMS within the following stimulation parameters: 20 Hz, at 120% of MT, 60 trains (1.0 second per train), 20 pulses per train, inter-train interval of 15 seconds, for a total of 1200 pulses over 16 minute, Sham stimulation session targeting the precuneus. The active and sham functions share the same acoustic properties and sham mimics cutaneous stimulation, facilitating double-blinding. |
| sham rTMS first, then 1 Hz rTMS Stimulation, then 20 Hz rTMS Stimulation | Experimental | Device: 1 Hz rTMS Stimulation, Device: Sham rTMS StimulationSubjects will receive one session of each: low frequency rTMS within the following stimulation parameters: Continuous 20-minute train of 1 Hz rTMS, at 120% of motor threshold (MT), for a total of 1200 pulses, high frequency rTMS within the following stimulation parameters: 20 Hz, at 120% of MT, 60 trains (1.0 second per train), 20 pulses per train, inter-train interval of 15 seconds, for a total of 1200 pulses over 16 minute, Sham stimulation session targeting the precuneus. The active and sham functions share the same acoustic properties and sham mimics cutaneous stimulation, facilitating double-blinding. |
| sham rTMS first, then 20 Hz rTMS Stimulation, then 1 Hz rTMS Stimulation | Experimental | Device: 1 Hz rTMS Stimulation, Device: Sham rTMS StimulationSubjects will receive one session of each: low frequency rTMS within the following stimulation parameters: Continuous 20-minute train of 1 Hz rTMS, at 120% of motor threshold (MT), for a total of 1200 pulses, high frequency rTMS within the following stimulation parameters: 20 Hz, at 120% of MT, 60 trains (1.0 second per train), 20 pulses per train, inter-train interval of 15 seconds, for a total of 1200 pulses over 16 minute, Sham stimulation session targeting the precuneus. The active and sham functions share the same acoustic properties and sham mimics cutaneous stimulation, facilitating double-blinding. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Between 18 and 40 years of age
- Within 10 years of illness onset as defined by entry into treatment for psychotic symptoms
- Able to give informed consent
- Willing and able to adhere to the study schedule
- Structured Clinical Interview for DSM-5 (SCID-5) diagnosis of schizophrenia
Key exclusion criteria (15 listed)
- Lifetime history of a seizure, excluding febrile seizures and those induced by substance withdrawal
- First degree relative with idiopathic epilepsy or other seizure disorder
- History of significant neurological illness
- History of head trauma as defined by a loss of consciousness or a post-concussive syndrome
- Pregnant or breast feeding
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 |
|---|---|---|
| 1 Hz rTMS StimulationAlso: rTMSrTMS is an electromagnetic device that provides non-invasive stimulation to the cortex or a sham placebo stimulation that mimics properties without stimulation. | Device | 1 Hz rTMS Stimulation first, then 20 Hz rTMS Stimulation, then sham rTMS, 1 Hz rTMS Stimulation first, then sham rTMS, then 20 Hz rTMS Stimulation, 20 Hz rTMS Stimulation first, then 1 Hz rTMS Stimulation, then sham rTMS, 20 Hz rTMS Stimulation first, then sham rTMS, then 1 Hz rTMS Stimulation, sham rTMS first, then 1 Hz rTMS Stimulation, then 20 Hz rTMS Stimulation, sham rTMS first, then 20 Hz rTMS Stimulation, then 1 Hz rTMS Stimulation |
| Sham rTMS StimulationrTMS is an electromagnetic device that provides non-invasive stimulation to the cortex or a sham placebo stimulation that mimics properties without stimulation. | Device | 1 Hz rTMS Stimulation first, then 20 Hz rTMS Stimulation, then sham rTMS, 1 Hz rTMS Stimulation first, then sham rTMS, then 20 Hz rTMS Stimulation, 20 Hz rTMS Stimulation first, then 1 Hz rTMS Stimulation, then sham rTMS, 20 Hz rTMS Stimulation first, then sham rTMS, then 1 Hz rTMS Stimulation, sham rTMS first, then 1 Hz rTMS Stimulation, then 20 Hz rTMS Stimulation, sham rTMS first, then 20 Hz rTMS Stimulation, then 1 Hz rTMS Stimulation |
Primary outcome
Change in Precuneus Functional Activation
Time frame: 1 day
Change in estimated beta coefficients for the Target vs. Foil contrast during scene recognition in the precuneus. Beta coefficients reflect the strength of the blood oxygen-level dependent (BOLD) signal during each condition.Target images are those previously shown to participants, and Foil images have not been previously shown, as participants indicate whether they have been shown images. A higher measure indicates that the intervention increased brain activity during recognition of previously shown scenes.
Precuneus Functional Connectivity
Time frame: 1 day
Blood oxygen level dependent (BOLD) signal functional connectivity with the precuneus in the bilateral dorsolateral prefrontal cortex, hippocampus, and anterior cingulate cortex. Value is the mean Fisher's transform of the correlation of BOLD time-series in the precuneus with the BOLD time-series in other named regions. Higher values indicate greater connectivity with the precuneus following the intervention. Value of zero indicates no relationship (no connectivity). This value has no unit of measurement.
Performance During In-scanner Episodic Memory Task
Time frame: 1 day
Percent accuracy (0-100%) on detecting whether an image shown during a scene recognition was among those shown during the previous five-minute session. Higher scores indicate better performance in recalling images.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- 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.
Tom Hummer principal investigator
Indiana University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1 Hz rTMS Stimulation in people with Schizophrenia, run by Indiana University at 2 sites 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 8 inclusion and 15 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: finished, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 28 Jul 2023). 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?
Change in Precuneus Functional Activation (time frame: 1 day). The study lists 3 primary outcomes in all. 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 28 Jul 2023.