Actively Recruiting
Cerebellar Modulation of Cognition in Psychosis
Led by Mclean Hospital · Updated on 2026-03-17
95
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Mclean Hospital
Lead Sponsor
B
Beth Israel Deaconess Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating cognition in psychotic disorders such as schizophrenia, bipolar disorder, and schizoaffective disorder. The study aims to understand if magnetic stimulation can influence processing speed, which reflects how quickly people solve challenging tasks. This research focuses on cognitive impairments that contribute to disability and poor quality of life, exploring a non-invasive method to temporarily alter brain activity. Participants will undergo different types of transcranial magnetic stimulation (TMS) including intermittent theta burst stimulation (iTBS), continuous theta burst stimulation (cTBS), and a sham (placebo) version. Each participant completes brain scans using magnetic resonance imaging (MRI) and cognitive testing before and after TMS sessions to observe changes in cognitive performance and brain circuits. The study uses these methods to compare the effects of the various TMS patterns on cognition. During the study, participants perform cognitive tasks and have MRI scans several times to measure brain activity and processing speed before and after each TMS session. The main outcomes measured include scores on cognitive tests such as the BACS Symbol Coding and BACS Digit Sequence tests, as well as functional MRI results. This study involves a randomized design with single masking and follows participants through multiple TMS visits to assess changes over time.
CONDITIONS
Brief Title
Cerebellar Modulation of Cognition in Psychosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 55 years
- Diagnosis of a psychotic disorder such as schizophrenia, schizoaffective disorder, or bipolar disorder type I
- Able to read, speak, and understand English
- Capable of completing study procedures as judged by study staff
- In stable outpatient treatment with no hospitalizations or medication changes in the past 30 days
You will not qualify if you...
- Moderate substance use disorder diagnosis within the past month
- Conditions increasing risk from rTMS or MRI, including:
- Intracranial pathology from genetic or acquired neurological diseases
- History of fainting spells that may indicate seizures
- History of seizures or epilepsy
- Progressive neurological disorders like multiple sclerosis or Parkinson's disease
- Uncontrolled medical conditions that could cause emergencies during seizures
- Presence of metal implants (except dental fillings) unless MRI-compatible joint replacements
- Having a pacemaker, implanted medication pump, vagal nerve stimulator, deep brain stimulator, or transcutaneous electric nerve stimulation unit
- Ventriculo-peritoneal shunt
- Signs of increased intracranial pressure or intracranial lesions
- History of head injury causing prolonged loss of consciousness or neurological complications
- Pregnancy; pregnancy tests required for those who may become pregnant, and pregnant individuals will not enroll
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Three visits spaced according to the study schedule
Participants undergo three separate visits where they receive different transcranial magnetic stimulation (TMS) interventions — intermittent theta burst stimulation (iTBS), continuous theta burst stimulation (cTBS), and sham rTMS — with cognitive testing and MRI scans before and after each TMS session.
3 visits (in-person)
Trial Site Locations
Total: 2 locations
1
McLean Hospital
Belmont, Massachusetts, United States, 02478
Actively Recruiting
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
3
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