Cerebellar Modulation of Cognition in Psychosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorMclean Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Diagnostic and Statistical Manual 5 diagnosis of moderate substance use disorder within the past month
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
Trial design
Design model
Crossover
Treatments tested in this trial
intermittant theta burst stimulation (iTBS)
DeviceiTBS 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)
DevicecTBS consists of 3 pulses at 50 Hz repeated at 5 Hz (every 200ms) continuously for a total of 600 pulses
sham rTMS
Devicesham rTMS does not deliver a significant change in magnetic field strength
Treatment groups
95 Participants
are divided into 3 treatment groupsGroup A: Intermittent theta burst stimulation (iTBS)Active comparator 1 intervention
Group B: continuous theta burst stimulation (cTBS)Active comparator 1 intervention
Group C: sham rTMSSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
BACS Symbol Coding test
The BACS Symbol coding test is a test of information processing speed
Time frame
eight minutes before TMS and one minute after TMS on each of the three TMS visit days2
BACS Digit Sequence test
The BACS digit sequence test is a test of working memory performance
Time frame
five minutes before TMS and four minutes after TMS on each of the three TMS visit days3
functional Magnetic Resonance Imaging
resting-state (task free) functional connectivity
Time frame
fifteen minutes before TMS and nine minutes after TMS on each of the three TMS visit daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Mclean Hospital
Lead sponsor
Beth Israel Deaconess Medical Center
Collaborator
Source ClinicalTrials.gov