Cerebellar Modulation of Cognition in Psychosis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorMclean Hospital

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Diagnostic and Statistical Manual 5 diagnosis of moderate substance use disorder within the past month

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

Trial design

Treatments tested in this trial

  • intermittant theta burst stimulation (iTBS)
  • continuous theta burst stimulation (cTBS)
  • sham rTMS

Treatment groups

95 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Mclean Hospital

Lead sponsor

Beth Israel Deaconess Medical Center

Collaborator