RECRUITING

Cerebellar Modulation of Cognition in Psychosis

Conditions

Schizophrenia Schizoaffective Disorder Bipolar Disorder I Psychosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Cerebellar Modulation of Cognition in Psychosis

Quick Facts

Study Start:2024-07-31

Study Completion:2029-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06107764

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Locations (Sites)

McLean Hospital

Belmont, Massachusetts, 02478

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

United States

Collaborators and Investigators

Sponsor: Mclean Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-31

Study Completion Date2029-12

Study Record Updates

Study Start Date2024-07-31

Study Completion Date2029-12

Terms related to this study

Additional Relevant MeSH Terms

Schizophrenia
Schizoaffective Disorder
Bipolar Disorder I
Psychosis