Cerebellar Modulation of Cognition in Psychosis

NCT06107764 | Recruiting DMC FDA Device

• 1 other identifier: 2023P002474
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Schizophrenia; Schizoaffective Disorder; Bipolar Disorder I; Psychosis

Outcome Measures

Primary Outcomes (3)

• BACS Symbol Coding test

  The BACS Symbol coding test is a test of information processing speed

  eight minutes before TMS and one minute after TMS on each of the three TMS visit days

• BACS Digit Sequence test

  The BACS digit sequence test is a test of working memory performance

  five minutes before TMS and four minutes after TMS on each of the three TMS visit days

• functional Magnetic Resonance Imaging

  resting-state (task free) functional connectivity

  fifteen minutes before TMS and nine minutes after TMS on each of the three TMS visit days

Study Arms (3)

Intermittent theta burst stimulation (iTBS)

ACTIVE COMPARATOR

Participants complete MRI scanning and cognitive testing followed by rTMS (iTBS pattern) followed by repeat cognitive testing and MRI scanning

Device: intermittant theta burst stimulation (iTBS)

continuous theta burst stimulation (cTBS)

ACTIVE COMPARATOR

Participants complete MRI scanning and cognitive testing followed by rTMS (cTBS pattern) followed by repeat cognitive testing and MRI scanning

Device: continuous theta burst stimulation (cTBS)

sham rTMS

SHAM COMPARATOR

Participants complete MRI scanning and cognitive testing followed by sham rTMS followed by repeat cognitive testing and MRI scanning

Device: sham rTMS

Interventions

intermittant theta burst stimulation (iTBS) DEVICE

iTBS consists of 2 s trains of 3 pulses at 50 Hz, repeated at 5 Hz, every 10s for a total of 600 pulses.

Intermittent theta burst stimulation (iTBS)

continuous theta burst stimulation (cTBS) DEVICE

cTBS consists of 3 pulses at 50 Hz repeated at 5 Hz (every 200ms) continuously for a total of 600 pulses

continuous theta burst stimulation (cTBS)

sham rTMS DEVICE

sham rTMS does not deliver a significant change in magnetic field strength

sham rTMS

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mclean Hospital: lead
• Beth Israel Deaconess Medical Center: collaborator

Study Sites (2)

McLean Hospital

Belmont, Massachusetts, 02478, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The study design is a crossover design i.e. all participants will receive all three rTMS interventions (iTBS, cTBS, sham rTMS). The participant will be blinded to which intervention is happening on a given study visit. The order of these visits will be determined randomly for each participant.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry, McLean Hospital

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: October 30, 2023
• Study Start: July 31, 2024
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: March 17, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)