A study of antipsychotic response and cognition using TMS-EEG V1
Overview
Participants wanted for brain stimulation –EEG study
A novel TMS-EEG study of GABAergic and glutamatergic neurotransmission and cognitive control in antipsychotic treatment response in schizophrenia
Researchers at the Institute of Psychiatry, Psychology and Neuroscience, King’s College London are seeking healthy volunteers aged 18 – 55 for a Transcranial Magnetic Stimulation (TMS) – Electroencephalography (EEG) study.
We would like to invite you to take part as a healthy control participant in a research study relating to the brain response to antipsychotics in people diagnosed with schizophrenia or schizoaffective disorder.
We will use a brain stimulation technique called Transcranial Magnetic Stimulation (TMS) to activate the brain and we will record the brain activity using electroencephalography (EEG). Both TMS and EEG are normally completely safe and have been used for many years. We will also ask you to complete some tests of thinking abilities. You will not be asked to take any medications during the study.
This study involves three visits to the NIHR/Wellcome King’s Clinical Research Facility (CRF) at King’s College Hospital. Each visit will take no more than 2 and 45 minutes.
Volunteers will be reimbursed for their time.
Recruitment for the study will close at the end of September 2024.
Thank you for your time!
Are you interested in taking part in this study?
Planned end date
31 Dec 2024 19:54Conditions
SchizophreniaInclusion Criteria
Inclusion criteria for all participants
Males or females
Aged between 18-55
Right-handed
Score< = 20 in Beck Depression Inventory
Physically healthy based on medical history as per interview at screening visit and medical notes
Negative urine pregnancy test at screening visit
Sufficient command of English to complete study-related assessments
Capacity to give written informed consent
Additional Inclusion criteria for patients
Schizophrenia/Schizoaffective Disorder diagnosis as per DSM-5
Outpatient with no hospitalisation for worsening of schizophrenia/schizoaffective disorder within at least 3 months prior to screening visit
Stable antipsychotic treatment for at least 3 months prior to screening visit and adherent with treatment, as per self-report and medical notes
AP monotherapy with either olanzapine, aripiprazole, risperidone or paliperidone for both responder and non-responder groups
Responders will have a score of 3 or less on all items of the Positive and Negative Symptom Scale (PANSS)
Non-responders will have: i) a score of at least 4 (moderate) on at least two positive symptom items of the PANSS and ii) at least two prior antipsychotic trials of at least 4-6 weeks duration with inadequate clinical improvement
Additional inclusion criteria for Healthy controls
No personal or family history of psychotic disorder
Exclusion Criteria
Exclusion criteria for all participants
Diagnosis of alcohol or substance dependence (other than nicotine) in the last 6 months preceding the screening visit as per Mini International Neuropsychiatric Interview (MINI) and the participant’s medical notes
Treatment with CNS active medications (other than antipsychotics for patients) that may affect performance on the study-related tasks, such as benzodiazepines, sleep medications or stimulants in the last 3 months prior to screening visit
Severe/uncontrolled/unstable physical illnesses that may affect participation in the study or pose a risk to the participant’s safety such as, uncontrolled diabetes, hypertension, asthma, cardiac-related problems including syncopal episodes
Systematic neurological disorder, including stroke, significant traumatic brain injury, epilepsy, multiple sclerosis, Parkinson's disease
Significant head or spinal cord injury
Diagnosis of migraine
Pregnancy or lactation
Unwillingness or inability to follow the protocol procedures
Participation in research studies using brain stimulation or cognitive enhancing medications in the last 3
months prior to screening visit
Contraindications to TMS as per TMS safety guidelines including:
History of epileptic seizures and/or previous or current diagnosis of epilepsy as per participant’s medical r records
On medications with seizure threshold lowering potential including imipramine, amitriptyline, doxepine, nortriptyline, maprotiline, chlorpromazine, foscarnet, ganciclovir, ritonavir, theophylline, chloroquine, mefloquine, imipenem, penicillin, ampicillin, cephalosporins, metronidazole, isoniazid, levofloxacin, cyclosporin, chlorambucil, vincristine, methotrexate, cytosine arabinoside, lithium, sympathomimetics.
Presence of metallic hardware and /or implants that contain magnets on the skull/brain, such as intracranial ferromagnetic metal implants, cochlear implants or medications pumps, implanted neurostimulators, such as Deep Brain Stimulators
Cardiac pacemaker or intracardiac lines
Presence of metal in the body
Additional exclusion criteria for patients:
Current treatment with Clozapine or unsuccessful trial with Clozapine in the last 3 months prior to screening visit
Electroconvulsive therapy (ECT) in the last 6 months prior to the screening visit
