Status:
RECRUITING
Cerebellar Modulation of Cognition in Psychosis
Lead Sponsor:
Mclean Hospital
Collaborating Sponsors:
Beth Israel Deaconess Medical Center
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief 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 m...
Detailed Description
Psychotic disorders including schizophrenia, bipolar disorder, and related illnesses are severe, debilitating, and often fatal. Cognitive impairments in psychosis are among the leading predictors of d...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT06107764
Start Date
July 31 2024
End Date
December 1 2029
Last Update
August 7 2024
Active Locations (2)
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1
McLean Hospital
Belmont, Massachusetts, United States, 02478
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215