Using magnetic stimulation to improve cognition in psychotic disorders
Cerebellar Modulation of Cognition in Psychosis
This study is testing whether a type of brain stimulation called TMS can help improve thinking skills in people with psychotic disorders like schizophrenia and bipolar disorder.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 95 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Mclean Hospital Academic / other |
| Locations | 2 sites (Belmont, Massachusetts and 1 other locations) |
| Trial ID | NCT06107764 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to investigate the effects of transcranial magnetic stimulation (TMS) on cognitive performance in individuals with psychotic disorders such as schizophrenia, schizoaffective disorder, and bipolar disorder. Participants will perform cognitive tasks and undergo brain scans before and after receiving different forms of TMS to assess changes in processing speed and brain activity. The study seeks to determine if cognitive impairments in these disorders can be modified non-invasively, providing insights into potential new interventions for improving quality of life. TMS is already FDA-approved for other psychiatric conditions, making this approach a promising avenue for treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-55 with a diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder type I who are stable in their outpatient treatment.
Not a fit: Patients with a recent history of substance use disorder or those with certain neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new non-invasive treatments that improve cognitive function in patients with psychotic disorders.
How similar studies have performed: While TMS has been successfully used for other psychiatric disorders, this specific application for cognitive enhancement in psychosis is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Belmont, Massachusetts and 1 other locations
- McLean Hospital — Belmont, Massachusetts, United States (Recruiting)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.