RecruitingNot ApplicableNCT06107764

Cerebellar Modulation of Cognition in Psychosis


Sponsor

Mclean Hospital

Enrollment

95 participants

Start Date

Jul 31, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study is exploring how a part of the brain called the cerebellum affects thinking and memory in people with psychotic disorders like schizophrenia. Researchers will use a brain stimulation technique (rTMS) and brain scans (MRI) to better understand this connection. **You may be eligible if...** - You are between 18 and 55 years old - You have been diagnosed with schizophrenia, schizoaffective disorder, or bipolar disorder type I - You read, speak, and understand English - You are in stable outpatient treatment with no hospitalizations or medication changes in the past 30 days **You may NOT be eligible if...** - You have epilepsy or a history of multiple seizures - You have metal implants, a pacemaker, a deep brain stimulator, or other implanted devices - You have a progressive neurological disease like MS or Parkinson's - You have had a serious head injury with prolonged loss of consciousness - You have a moderate substance use disorder in the past month - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEintermittant theta burst stimulation (iTBS)

iTBS consists of 2 s trains of 3 pulses at 50 Hz, repeated at 5 Hz, every 10s for a total of 600 pulses.

DEVICEcontinuous theta burst stimulation (cTBS)

cTBS consists of 3 pulses at 50 Hz repeated at 5 Hz (every 200ms) continuously for a total of 600 pulses

DEVICEsham rTMS

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


Locations(2)

McLean Hospital

Belmont, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

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NCT06107764


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