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Cerebellar Modulation of Cognition in Psychosis

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 55 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "These outcomes include performance on cognitive tests and also changes to the circuit itself that we can measure using magnetic resonance imaging (MRI)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether magnetic brain stimulation (TMS) can change how fast people solve hard tasks. It is for adults ages 18–55 with schizophrenia, schizoaffective disorder, or bipolar I disorder. Participants will do problem-solving tasks and have brain scans before and after TMS, which temporarily changes brain activity without surgery.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18–55 years old.
  • You have been diagnosed with schizophrenia, schizoaffective disorder, or bipolar I disorder.
  • You can read, speak, and understand English.
  • Study staff believe you can complete the study activities.
  • You are in stable treatment outside a hospital, with no hospital stays or medicine changes in the past 30 days.

Who can't join

  • You have had a moderate substance use disorder—a problem with alcohol or drug use—in the past month.
  • You have certain brain problems caused by a genetic condition or illness, such as a stroke or tumor; cerebral palsy; or major differences in body structure.
  • You have had a severe head injury, a head injury that left lasting nerve or brain problems, or one that made you pass out for more than 15 minutes.
  • You have had repeated seizures, have epilepsy, or have unexplained fainting spells that might be seizures.
  • You have a nerve or brain disease that gets worse over time, such as multiple sclerosis or Parkinson’s disease.
  • You have a long-term health condition, especially one not well controlled, that could cause an emergency during a seizure, such as certain heart problems or asthma.
  • You have metal implants not cleared by the study doctor (dental fillings are allowed); a pacemaker; an implanted medicine pump; a nerve or brain stimulator; a skin-based electrical nerve stimulation device; a tube draining brain fluid to the belly; or signs of high pressure or a damaged area inside the skull.
  • You are pregnant. Anyone who can become pregnant must take a pregnancy test.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (2)

MA