Recruiting

Cerebellar Modulation

Sponsor:

Mclean Hospital

Code:

NCT06107764

Conditions

Schizophrenia

Schizoaffective Disorder

Bipolar Disorder I

Psychosis

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

intermittant theta burst stimulation (iTBS)

continuous theta burst stimulation (cTBS)

sham rTMS

Study Details

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

Study ID

NCT06107764

Start date

Jul 31, 2024

Status verified date

Aug, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

95 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Intermittent theta burst stimulation (iTBS)

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

active comparator: continuous theta burst stimulation (cTBS)

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

sham comparator: sham rTMS

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

Interventions

intermittant theta burst stimulation (iTBS)

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

continuous theta burst stimulation (cTBS)

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

sham rTMS

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

Primary outcome measure

  • BACS Symbol Coding test [ Time Frame: eight minutes before TMS and one minute after TMS on each of the three TMS visit days ]
  • BACS Digit Sequence test [ Time Frame: five minutes before TMS and four minutes after TMS on each of the three TMS visit days ]
  • functional Magnetic Resonance Imaging [ Time Frame: fifteen minutes before TMS and nine minutes after TMS on each of the three TMS visit days ]

Central Contacts and Locations

Locations

McLean Hospital

Recruiting

Belmont, Massachusetts, United States, 02478

Contacts

Madelaine Nye, B.S.

617-855-2370mnye@mclean.harvard.edu

Principal Investigator:

Kathryn E Lewandowski, Ph.D.

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Madelaine Nye

617-632-7956mnye@bidmc.harvard.edu

Principal Investigator:

Roscoe O Brady, MD, PhD

More Information

Sponsor

Mclean Hospital

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mclean Hospital on 2026-08-20.