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Cerebellar Modulation of Cognition in Psychosis

Sponsor: Mclean Hospital • ClinicalTrials.gov ID: NCT06107764

Registry updated: 2026-08-20

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Description

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.

Interventions

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 rTMS (Device)
sham rTMS does not deliver a significant change in magnetic field strength

Eligibility criteria

Inclusion Criteria: * 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 Criteria: * 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.

Conditions

Schizophrenia Schizoaffective Disorder Bipolar Disorder I Psychosis

Locations

McLean Hospital — Belmont, Massachusetts, United States
Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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