Status:
COMPLETED
Behavioral Impact and Neural Correlates of Network-based Brain Stimulation in Schizophrenia
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
Beth Israel Deaconess Medical Center
Conditions:
SCHIZOPHRENIA 1 (Disorder)
Nicotine Use
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The primary aims of this study are to investigate the behavioral effects of applying targeted transcranial magnetic stimulation (TMS) to a node of the brain network subserving attention in schizophren...
Detailed Description
The primary aims of this study are to investigate the behavioral effects of applying targeted transcranial magnetic stimulation (TMS) to a node of the brain network subserving attention in schizophren...
Eligibility Criteria
Inclusion
- Age between 18-65 years
- At pre-visit screening (see attached phone screening questionnaire): Subjects must report that they have been given a diagnosis of schizophrenia or schizoaffective disorder by a mental health professional
- Current smoker (expired air CO of 5ppm or higher)
- Must be able to read, speak and understand English
- Must be judged by study staff to be capable of completing the study procedures
- Diagnosis of either schizophrenia or schizoaffective disorder according to DSM-V criteria and confirmed by SCID\[26\]
- Participants will be in stable outpatient treatment with no recent (within the past 30 days) hospitalizations or changes in their medication regimens.
Exclusion
- DSM-V intellectual disability
- Substance use disorder within the past three months
- Any history of a progressive or genetic neurologic disorder (e.g. Parkinson's disease, multiple sclerosis, tuberous sclerosis, Alzheimer's Disease) or acquired neurological disease (e.g. stroke, traumatic brain injury, tumor), including intracranial lesions
- History of head trauma resulting in any loss of consciousness (\>15 minutes) or neurological sequelae
- Current history of poorly controlled headaches including chronic medication for migraine prevention
- History of fainting spells of unknown or undetermined etiology that might constitute seizures
- History of seizures, diagnosis of epilepsy, or immediate (1st degree relative) family history epilepsy with the exception of a single seizure of benign etiology (e.g. febrile seizures) in the judgment of a board-certified neurologist
- Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)
- Any metal in the brain or skull (excluding dental fillings) or elsewhere in the body unless cleared by the responsible covering MD (e.g. MRI compatible joint replacement)
- Any devices such as pacemaker, medication pump, nerve stimulator, TENS unit, ventriculo-peritoneal shunt unless cleared by the responsible covering MD
- All female participants of child-bearing age will be required to have a pregnancy test; any participant who is pregnant will not be enrolled in the study
- Medications will be reviewed by the responsible covering physician and a decision about inclusion will be made based on the participant's past medical history, drug dose, history of recent medication changes or duration of treatment, and use of CNS active drugs. The published TMS guidelines review of medications to be considered with rTMS will be taken into consideration given their described effects on cortical excitability measures.
- Any changes in medications or hospitalizations within the past 30 days.
- Subjects who, in the investigator's opinion, might not be suitable for the study or would be unable to tolerate the study visit.
Key Trial Info
Start Date :
October 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 3 2022
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT07190352
Start Date
October 4 2021
End Date
October 3 2022
Last Update
September 24 2025
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215