Cerebellar Modulation of Cognition in Psychosis

This study is looking into how magnetic stimulation can affect thinking skills (cognition) in people with schizophrenia, schizoaffective disorder, or bipolar disorder I. Researchers want to see if using a device called transcranial magnetic stimulation (TMS) can change how quickly people solve problems. You would receive different forms of TMS, including intermittant theta burst stimulation (iTBS), continuous theta burst stimulation (cTBS), or a sham rTMS (which doesn't deliver a significant magnetic field). Before and after TMS, you would complete problem-solving tasks and have brain scans. The study aims to enroll 95 participants aged 18-55 who have one of these diagnoses and are in stable outpatient treatment.

Study design
This is an interventional study planning to enroll 95 participants. It tests different forms of transcranial magnetic stimulation (TMS) against a sham treatment.
What's involved
You would perform cognitive tasks and undergo brain scans before and after TMS on three separate visit days. Each visit involves measurements taken before and after TMS.
Compensation
Not stated in the trial record.
Follow-up
Measurements are taken shortly after TMS on each of the three visit days, but no long-term follow-up is specified.

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NCT06107764

Cerebellar Modulation of Cognition in Psychosis

Recruiting
NAAges 18–55Interventional
Mclean Hospital
~95 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:intermittant theta burst stimulation (iTBS)continuous theta burst stimulation (cTBS)sham rTMS

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
BACS Symbol Coding test
Measured over eight minutes before TMS and one minute after TMS on each of the three TMS visit days
+2 more outcomes measured
Schizophrenia
Schizoaffective Disorder
Bipolar Disorder I
Psychosis
2 sites across 1 states
Massachusetts2

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Eligibility criteria

Inclusion

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.

Exclusion

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
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.
  • BACS Symbol Coding testeight 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 testfive 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 Imagingfifteen minutes before TMS and nine minutes after TMS on each of the three TMS visit days

    resting-state (task free) functional connectivity