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Cerebellar Modulation of Cognition in Psychosis

RecruitingNA

Sponsor: Mclean Hospital

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

Interventions: intermittant theta burst stimulation (iTBS), continuous theta burst stimulation (cTBS), sham rTMS

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to 55 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion 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.

Exclusion Criteria:

* 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.

Locations (2)

Belmont, Massachusetts, United States
Boston, Massachusetts, United States