Cerebellar Modulation of Cognition in Psychosis

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Schizophrenia, Schizoaffective Disorder, Bipolar Disorder I, Psychosis

In brief

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.

Key facts

Study ID

NCT06107764

Run by

Mclean Hospital

People needed

95

Starts

2024-07-31

Expected to finish

2029-12-01

Last updated by the study team

2026-03-17

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• McLean Hospital — Belmont, Massachusetts, United States (enrolling)
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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