Behavioral Impact and Neural Correlates of Network-based Brain Stimulation in Schizophrenia

Completed · Not applicable · Has a placebo group

Conditions studied: SCHIZOPHRENIA 1 (Disorder), Nicotine Use

In brief

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 schizophrenia and schizoaffective disorder and to correlate these effects to changes in brain network connectivity. Assumptions: -Cerebral activity can be investigated through the correlated activity of cortical nodes that constitute functional brain networks -Behavior can be correlated to the strength of correlated activity between and within nodes of these cortical networks -TMS to targeted nodes leads to changes in patterns of activity in these cortical networks Hypothesis: TMS to a node of the attention network in schizophrenia or schizoaffective disorder will influence network connectivity leading to measurable and predictable effects on attention.

Key facts

Study ID

NCT07190352

Run by

Beth Israel Deaconess Medical Center

People needed

15

Starts

2021-10-04

Expected to finish

2022-10-03

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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