Actively Recruiting

Phase Not Applicable
Age: 18Years - 55Years
All Genders
NCT06107764

Cerebellar Modulation of Cognition in Psychosis

Led by Mclean Hospital · Updated on 2026-03-17

95

Participants Needed

2

Research Sites

278 weeks

Total Duration

On this page

Sponsors

M

Mclean Hospital

Lead Sponsor

B

Beth Israel Deaconess Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Cerebellar Modulation of Cognition in Psychosis

Who Can Participate

Age: 18Years - 55Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18-55 years
  • Diagnosis of a psychotic disorder (schizophrenia, schizoaffective disorder, or bipolar disorder type I)
  • Ability to read, speak, and understand English
  • Judged capable by study staff to complete study procedures
  • Stable outpatient treatment with no hospitalizations or medication changes in the past 30 days
Not Eligible

You will not qualify if you...

  • Moderate substance use disorder diagnosed within the past month
  • Intracranial pathology from genetic or acquired neurological disease (e.g., Neurofibromatosis 1, tuberous sclerosis, stroke, tumor)
  • Cerebral palsy, history of severe head injury, or significant dysmorphology
  • History of fainting spells of unknown cause that might be seizures
  • History of multiple seizures or diagnosis of epilepsy
  • Progressive neurological disorders like multiple sclerosis or Parkinson's disease
  • Chronic uncontrolled medical conditions that increase seizure risk (e.g., cardiac malformation, dysrhythmia, asthma)
  • Metal implants (except dental fillings) unless MRI compatible and cleared by doctor
  • 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 with prolonged loss of consciousness (>15 minutes) or neurological effects
  • Pregnancy; participants capable of becoming pregnant must have a negative pregnancy test to enroll

AI-Screening

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Trial Site Locations

Total: 2 locations

1

McLean Hospital

Belmont, Massachusetts, United States, 02478

Actively Recruiting

2

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

OTHER

Number of Arms

3

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