SchizophreniaNCT06107764
Cerebellar Modulation of Cognition in Psychosis
A study testing intermittant theta burst stimulation (iTBS) and continuous theta burst stimulation (cTBS) in people with Schizophrenia and Schizoaffective Disorder, run by Mclean Hospital at 2 sites in United States.
Trial summary
The goal of this clinical trial is to learn about cognition in psychotic disorders (schizophrenia, bipolar disorder, and schizoaffective disorder). The main question it aims to answer is: Can we use magnetic stimulation to change processing speed (how quickly people can solve challenging tasks). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Bipolar Disorder I
- What is being tested?
- intermittant theta burst stimulation (iTBS) and continuous theta burst stimulation (cTBS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Jul 2024to Dec 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18-55 years
- Diagnosis of a psychotic disorder (i.e. schizophrenia or schizoaffective disorder or bipolar disorder type I)
- Must be able to read, speak and understand English
- Must be judged by study staff to be capable of completing the study procedures
- Participants will be in stable outpatient treatment with no recent (within the past 30 days) hospitalizations or changes in their medication regimens.
Who cannot join
- Diagnostic and Statistical Manual 5 diagnosis of moderate substance use disorder within the past month
- Conditions that might result in increased risks of side effects or complications from rTMS or MRI, including:
- Intracranial pathology from a known genetic disorder (e.g., Neurofibromatosis 1, tuberous sclerosis) or from acquired neurologic disease (e.g. stroke, tumor), cerebral palsy, history of severe head injury, or significant dysmorphology;
- History of fainting spells of unknown or undetermined etiology that might constitute seizures
- History of multiple seizures or diagnosis of epilepsy
- Any progressive (e.g., neurodegenerative) neurological disorder such as multiple sclerosis or Parkinson's disease
Show all 17Show fewer
- Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)
- Metal implants (excluding dental fillings) unless cleared by the responsible covering MD (i.e. MRI compatible joint replacement)
- Pacemaker
- Implanted medication pump
- Vagal nerve stimulator
- Deep brain stimulator or transcutaneous electric nerve stimulation unit
- Ventriculo-peritoneal shunt
- Signs of increased intracranial pressure
- Intracranial lesion
- History of head injury resulting in prolonged loss of consciousness (>15minutes) or neurological sequelae
- Pregnancy: All participants capable of becoming pregnant will be required to have a pregnancy test; any participant who is pregnant will not be enrolled in the study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
McLean Hospital
Belmont, Massachusetts, 02478
Madelaine Nye, B.S., 617-855-2370, mnye@mclean.harvard.edu
Kathryn E Lewandowski, Ph.D.
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Madelaine Nye, 617-632-7956, mnye@bidmc.harvard.edu
Roscoe O Brady, MD, PhD
About this study
The goal of this clinical trial is to learn about cognition in psychotic disorders (schizophrenia, bipolar disorder, and schizoaffective disorder). The main question it aims to answer is: Can we use magnetic stimulation to change processing speed (how quickly people can solve challenging tasks).
Participants will be asked to perform cognitive tasks (problem-solving) and undergo brain scans before and after transcranial magnetic stimulation (TMS). TMS is a way to non-invasively change brain activity. Forms of TMS are FDA-approved to treat depression and obsessive compulsive disorder. In this study, we will use a different form of TMS to temporarily change brain activity to observe how that changes speed in problem-solving.
Read the detailed description
Psychotic disorders including schizophrenia, bipolar disorder, and related illnesses are severe, debilitating, and often fatal. Cognitive impairments in psychosis are among the leading predictors of disability and poor quality of life; despite this, there are no first-line interventions to target these symptoms.
This trial will test the hypothesis that cognitive performance in these disorders is modifiable and specifically that it can be modified non-invasively. Transcranial magnetic stimulation (TMS) is a neuromodulation technique that utilizes magnets to alter brain activity non-invasively. TMS has received FDA approval as a therapeutic intervention for multiple psychiatric disorders. In this study, we will use different forms of TMS to modulate a specific brain circuit and we will measure the outcomes of this circuit manipulation. These outcomes include performance on cognitive tests and also changes to the circuit itself that we can measure using magnetic resonance imaging (MRI).
- Conditions
- Schizophrenia, Schizoaffective Disorder, Bipolar Disorder I, Psychosis
- Being tested
- intermittant theta burst stimulation (iTBS), continuous theta burst stimulation (cTBS), sham 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.
intermittant theta burst stimulation (iTBS)Device
iTBS consists of 2 s trains of 3 pulses at 50 Hz, repeated at 5 Hz, every 10s for a total of 600 pulses.
continuous theta burst stimulation (cTBS)Device
cTBS consists of 3 pulses at 50 Hz repeated at 5 Hz (every 200ms) continuously for a total of 600 pulses
sham rTMSDevice
sham rTMS does not deliver a significant change in magnetic field strength
| Study group | Role | What they receive |
|---|---|---|
| Intermittent theta burst stimulation (iTBS) | Active comparator | Participants complete MRI scanning and cognitive testing followed by rTMS (iTBS pattern) followed by repeat cognitive testing and MRI scanning Receives: Device: intermittant theta burst stimulation (iTBS) |
| continuous theta burst stimulation (cTBS) | Active comparator | Participants complete MRI scanning and cognitive testing followed by rTMS (cTBS pattern) followed by repeat cognitive testing and MRI scanning Receives: Device: continuous theta burst stimulation (cTBS) |
| sham rTMS | Sham comparator | Participants complete MRI scanning and cognitive testing followed by sham rTMS followed by repeat cognitive testing and MRI scanning Receives: Device: sham rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
BACS Symbol Coding test
The BACS Symbol coding test is a test of information processing speed
Measured: eight minutes before TMS and one minute after TMS on each of the three TMS visit days
BACS Digit Sequence test
The BACS digit sequence test is a test of working memory performance
Measured: five minutes before TMS and four minutes after TMS on each of the three TMS visit days
functional Magnetic Resonance Imaging
resting-state (task free) functional connectivity
Measured: fifteen minutes before TMS and nine minutes after TMS on each of the three TMS visit days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start31 Jul 2024
- Primary completionDec 2029 (estimated)
- Study completionDec 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.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center
- Responsible party
- Principal investigator, Kathryn Eve Lewandowski, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06107764
- Sponsor's protocol ID
- 2023P002474
- Status last verified
- Aug 2026
- First submitted
- 19 Oct 2023
- Last updated
- 20 Aug 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 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebellar Modulation of Cognition in Psychosis
- ClinicalTrials.gov ID
- NCT06107764
- Acronym / sponsor ID
- 2023P002474
- Conditions
- Schizophrenia, Schizoaffective Disorder, Bipolar Disorder I, Psychosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 30 Oct 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.
The goal of this clinical trial is to learn about cognition in psychotic disorders (schizophrenia, bipolar disorder, and schizoaffective disorder). The main question it aims to answer is: Can we use magnetic stimulation to change processing speed (how quickly people can solve challenging tasks).
Participants will be asked to perform cognitive tasks (problem-solving) and undergo brain scans before and after transcranial magnetic stimulation (TMS). TMS is a way to non-invasively change brain activity. Forms of TMS are FDA-approved to treat depression and obsessive compulsive disorder. In this study, we will use a different form of TMS to temporarily change brain activity to observe how that changes speed in problem-solving.
Detailed description
Psychotic disorders including schizophrenia, bipolar disorder, and related illnesses are severe, debilitating, and often fatal. Cognitive impairments in psychosis are among the leading predictors of disability and poor quality of life; despite this, there are no first-line interventions to target these symptoms.
This trial will test the hypothesis that cognitive performance in these disorders is modifiable and specifically that it can be modified non-invasively. Transcranial magnetic stimulation (TMS) is a neuromodulation technique that utilizes magnets to alter brain activity non-invasively. TMS has received FDA approval as a therapeutic intervention for multiple psychiatric disorders. In this study, we will use different forms of TMS to modulate a specific brain circuit and we will measure the outcomes of this circuit manipulation. These outcomes include performance on cognitive tests and also changes to the circuit itself that we can measure using magnetic resonance imaging (MRI).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intermittent theta burst stimulation (iTBS) | Active comparator | Device: intermittant theta burst stimulation (iTBS)Participants complete MRI scanning and cognitive testing followed by rTMS (iTBS pattern) followed by repeat cognitive testing and MRI scanning |
| continuous theta burst stimulation (cTBS) | Active comparator | Device: continuous theta burst stimulation (cTBS)Participants complete MRI scanning and cognitive testing followed by rTMS (cTBS pattern) followed by repeat cognitive testing and MRI scanning |
| sham rTMS | Sham comparator | Device: sham rTMSParticipants complete MRI scanning and cognitive testing followed by sham rTMS followed by repeat cognitive testing and MRI scanning |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 18-55 years
- Diagnosis of a psychotic disorder (i.e. schizophrenia or schizoaffective disorder or bipolar disorder type I)
- Must be able to read, speak and understand English
- Must be judged by study staff to be capable of completing the study procedures
- Participants will be in stable outpatient treatment with no recent (within the past 30 days) hospitalizations or changes in their medication regimens.
Key exclusion criteria (17 listed)
- Diagnostic and Statistical Manual 5 diagnosis of moderate substance use disorder within the past month
- Conditions that might result in increased risks of side effects or complications from rTMS or MRI, including:
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 |
|---|---|---|
| intermittant theta burst stimulation (iTBS)iTBS consists of 2 s trains of 3 pulses at 50 Hz, repeated at 5 Hz, every 10s for a total of 600 pulses. | Device | Intermittent theta burst stimulation (iTBS) |
| continuous theta burst stimulation (cTBS)cTBS consists of 3 pulses at 50 Hz repeated at 5 Hz (every 200ms) continuously for a total of 600 pulses | Device | continuous theta burst stimulation (cTBS) |
| sham rTMSsham rTMS does not deliver a significant change in magnetic field strength | Device | sham rTMS |
Primary outcome
BACS Symbol Coding test
Time frame: eight minutes before TMS and one minute after TMS on each of the three TMS visit days
The BACS Symbol coding test is a test of information processing speed
BACS Digit Sequence test
Time frame: five minutes before TMS and four minutes after TMS on each of the three TMS visit days
The BACS digit sequence test is a test of working memory performance
functional Magnetic Resonance Imaging
Time frame: fifteen minutes before TMS and nine minutes after TMS on each of the three TMS visit days
resting-state (task free) functional connectivity
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 20 Aug 2026.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intermittant theta burst stimulation (iTBS) and continuous theta burst stimulation (cTBS) in people with Schizophrenia and Schizoaffective Disorder, run by Mclean Hospital 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 5 inclusion and 17 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 20 Aug 2026. 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. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BACS Symbol Coding test (time frame: eight minutes before TMS and one minute after TMS on each of the three TMS visit days). 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 20 Aug 2026.