Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
95 participants
INTERVENTIONAL
2024-07-31
2029-12-31
Brief Summary
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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.
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Detailed Description
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This trial will test the hypothesis that cognitive performance in these disorders is modifiable and specifically that it can be modified non-invasively. Transcranial magnetic stimulation (TMS) is a neuromodulation technique that utilizes magnets to alter brain activity non-invasively. TMS has received FDA approval as a therapeutic intervention for multiple psychiatric disorders. In this study, we will use different forms of TMS to modulate a specific brain circuit and we will measure the outcomes of this circuit manipulation. These outcomes include performance on cognitive tests and also changes to the circuit itself that we can measure using magnetic resonance imaging (MRI).
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
SINGLE
Study Groups
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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
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)
Participants complete MRI scanning and cognitive testing followed by rTMS (cTBS pattern) followed by repeat cognitive testing and MRI scanning
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
Participants complete MRI scanning and cognitive testing followed by sham rTMS followed by repeat cognitive testing and MRI scanning
sham rTMS
sham rTMS does not deliver a significant change in magnetic field strength
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
55 Years
ALL
No
Sponsors
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Beth Israel Deaconess Medical Center
OTHER
Mclean Hospital
OTHER
Responsible Party
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Kathryn Eve Lewandowski
Associate Professor of Psychiatry, McLean Hospital
Locations
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McLean Hospital
Belmont, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Countries
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Facility Contacts
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Other Identifiers
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2023P002474
Identifier Type: -
Identifier Source: org_study_id
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